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  7. Competitive Generic Therapy Approvals
  1. Generic Drugs

Competitive Generic Therapy Approvals

The Office of Generic Drugs is providing a public list of all approved abbreviated new drug application (ANDAs) for drug products that received a Competitive Generic Therapy (CGT) designation under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and is also noting which ANDAs on this list cover drug products that were also eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.  This list will be updated on a bi-weekly basis with new ANDA approvals where at least one of the drug products, i.e., one of the strengths, in the approved application received a CGT designation.

The Agency is including the following information for individual drug products on the CGT Approvals List:

  • Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number
    This column reflects the proprietary name, if any, of the RLD and its NDA number.
  • ANDA Number
  • ANDA Applicant
  • Active Ingredient Name, Dosage Form, Strength
    This column reflects the established (nonproprietary) name of the active ingredient(s) in the drug product, as well as the product’s dosage form and strength(s).
  • Date of Approval
    This column indicates the date on which an ANDA for a CGT-designated drug product(s) received final approval.
  • Eligible for CGT Exclusivity
    In this column, drug products that, at the time of approval, were eligible for CGT exclusivity will be indicated with a “Yes,” while drug products that were not eligible for CGT exclusivity at the time of approval will be indicated with a “No.”  Certain products in ANDAs designated as CGTs can qualify for CGT exclusivity if the applicant is a “first approved applicant” as defined in section 505(j)(5)(B)(v) of the FD&C Act.  There is only one exclusivity period available for each CGT, and receiving a CGT designation does not ensure that a drug product will be eligible for CGT exclusivity.  For example, a drug product in an ANDA that receives a CGT designation will not be eligible for CGT exclusivity if there were unexpired patents or exclusivities listed in the Orange Book at the time of the original submission of the ANDA for the CGT-designated drug product.
  • CGT Exclusivity Forfeiture
    This column indicates whether or not a drug product that was eligible for CGT exclusivity upon approval forfeited eligibility because it was not commercially marketed within 75 days after the date of approval of the ANDA (see section 505(j)(5)(D)(iv) of the FD&C Act).  A forfeiture event is indicated with “Yes.” Non-forfeiture is indicated with “No.”  If the forfeiture determination has not yet been made, the column will be blank, and if the CGT was not eligible for exclusivity upon approval, the column will reflect “N/A.” If the first approved applicant has voluntarily relinquished the CGT exclusivity, the column will reflect “Relinquished.”
  • Date of First Commercial Marketing of CGT with Exclusivity
    This column reflects the date of first commercial marketing of a CGT by a first approved applicant of a drug product that was eligible for CGT exclusivity and did not forfeit its eligibility.  The 180-day CGT exclusivity period described under section 505(j)(5)(B)(v) of the FD&C Act is triggered by the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.  This 180-day CGT exclusivity period, once triggered, blocks the approval of an ANDA for a drug that is the same as the CGT.  If the CGT was not granted exclusivity, or the exclusivity was forfeited, the column will reflect “N/A.”

FDA intends that the information on the list will provide transparency to prospective applicants and other interested parties with respect to the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity.  FDA believes that this information will be useful to help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition, and will also aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (as noted above, there is only one exclusivity period for each CGT).  By providing the commercial marketing start date for CGT exclusivity periods, this list will also provide useful information to applicants whose ANDAs have been blocked from final approval by CGT exclusivity regarding when the exclusivity period will expire.  To note, FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) also posts a Competitive Generic Therapy (CGT) code in the “Exclusivity Data” section of the Orange Book for the approved drug products eligible for 180-day CGT exclusivity upon any first approved applicant’s commercial marketing, indicating the date the 180-day CGT exclusivity will expire.

Competitive Generic Therapy Approvals

  RLD Name and NDA Number ANDA Number ANDA Applicant Active Ingredient Name, Dosage Form, Strength  Date of Approval Eligible for CGT Exclusivity CGT Exclusivity Forfeiture Date of First Commercial Marketing of CGT with Exclusivity
209 Fosamax Oral Solution, NDA 021575 214512 Novitium Pharma LLC Alendronate Sodium Oral Solution, 70 mg (base)/75 mL 5/12/2023 Yes    
208 Dexamethasone Tablets, ANDA 081916 217696 Novitium Pharma LLC Dexamethasone Tablets USP, 2 mg 5/9/2023 No N/A N/A
207 Calcium DisodiumVersenate Injection, NDA 008922 216435 Casper Pharma LLC Edetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial 5/2/2023 Yes    
206 Celontin, NDA 010596 217213 Novitium Pharma LLC Methsuximide Capsules USP, 300 mg 5/1/2023 Yes No 5/1/2023
205 Dexamethasone Tablets USP, ANDA 087916 217538 Bionpharma Inc. Dexamethasone Tablets USP, 2 mg 4/26/2023 No N/A N/A
204 Tazorac Gel, NDA 020600 213079 Padagis Israel Pharmaceuticals Ltd. Tazarotene Gel, 0.05% and 0.1% 4/25/2023 No N/A N/A
203 Alrex Ophthalmic Suspension, NDA 020803 215933 Akorn Operating Company LLC Loteprednol Etabonate Ophthalmic Suspension, 0.2% 4/12/2023 Yes    
202 Uceris Rectal Foam, NDA 205613 215328 Padagis Israel Pharmaceuticals Ltd. Budesonide Rectal Foam, 2 mg/dose 4/12/2023 Yes No 4/27/2023
201 Paraflex Tablets, NDA 011300 214702 Corepharma, LLC Chlorzoxazone Tablets USP, 250 mg 4/10/2023 No N/A N/A
200 Arranon Injection, NDA 021877 216346 Amneal Pharmaceuticals LLC Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial 4/4/2023 No N/A N/A
199 Alphagan P Ophthalmic Solution, NDA 021262 215225 Syneos Health, LLC Brimonidine Tartrate Ophthalmic Solution, 0.15% 3/29/2023 No N/A N/A
198 Amitiza Capsules, NDA 021908 214131 Zydus Pharmaceuticals (USA) Inc. Lubiprostone Capsules, 8 mcg and 24 mcg 3/23/2023 No N/A N/A
197 Enstilar Foam, NDA 207589 214688 Glenmark Pharmaceuticals Inc., USA Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% 3/21/2023 No N/A N/A
196 Tazorac Gel, NDA 020600 213644 Solaris Pharma Corporation Tazarotene Gel, 0.05% and 0.1% 3/20/2023 No N/A N/A
195 Prednisolone Tablet USP, ANDA 080354 215673 Aurobindo Pharma Limited Prednisolone Tablets USP, 5 mg 3/17/2023 Yes    
194 Arranon Injection, NDA 021877 214809 Shorla Pharma Limited Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial   3/3/2023     No N/A N/A
193 Advil Dual Action with Acetaminophen Tablets, NDA 211733 214836 L. Perrigo Company Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) 2/28/2023 No N/A N/A
192 Thiola EC Tablets, NDA 211843 217219 Par Pharmaceutical Inc. Tiopronin Delayed-Release Tablets, 100 mg and 300 mg 2/24/2023 No N/A N/A
191 Zonalon Cream, NDA 021026 215408 Teva Pharmaceutical Development, Inc. Doxepin Hydrochloride Cream, 5% 2/17/2023 Yes No 2/17/2023
190 Trokendi XR Extended Release Capsules, NDA 201635 216167 Zydus Pharmaceuticals (USA) Inc. Topiramate Extended-Release Capsules, 200 mg 2/9/2023 No N/A N/A
189 Parafon Forte DSC, NDA 011529 212047 Appco Pharma LLC Chlorzoxazone Tablets USP, 375 mg and 750 mg 1/27/2023 No N/A N/A
188 Cysteine Hydrochloride Injection, NDA 019523 213073 Nivagen Pharmaceuticals, Inc. Cysteine Hydrochloride Injection USP, 725 mg/10 mL (72.5 mg/mL) Single-Dose Vial 1/26/2023 Yes    
187 Phenylephrine Hydrochloride, NDA 207926 216496 Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution USP, 10% 1/11/2023 Yes No 1/18/2023
186 Arranon Injection, NDA 021877 216038 Meitheal Pharmaceuticals, Inc. Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial 1/10/2023 No N/A N/A
185 Orfadin Capsules, NDA 021232 215908 Torrent Pharma Inc. Nitisinone Capsules, 20 mg 1/9/2023 Yes Yes N/A
184 Zinc Sulfate Injection, NDA 209377 216145 Fresenius Kabi USA, LLC Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package 12/27/2022 Yes (10 mg/10 mL); No (30 mg/10 mL); No (25 mg/5 mL) No 2/15/2023
183 Cupric Sulfate Injection, NDA 019350 216324 American Regent, Inc. Cupric Sulfate Injection USP, 4 mg/10 mL (0.4 mg/mL) Pharmacy Bulk Package 12/26/2022 Yes Yes N/A
182 Uptravi Tablets, NDA 207947 214302 Zydus Worldwide DMCC Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg 12/21/2022 No N/A N/A
181 Perforomist Inhalation Solution, NDA 22007 215621 Slayback Pharma LLC Formoterol Fumarate Solution 20 mcg/2 mL per Unit Dose Vial 12/13/2022 No N/A N/A
180 Potassium Chloride Oral Solution, NDA 206814 211665 Strides Pharma Global Pte Limited Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%) 11/17/2022 No N/A N/A
179 AmBisome Liposome for Injection, NDA 050740 214010 Eugia US LLC Amphotericin B Injection, 50 mg/vial Single-Dose Vial 11/17/2022 No N/A N/A
178 Durezol Ophthalmic Emulsion, NDA 022212 214894 Dr. Reddy's Laboratories Limited Difluprednate Ophthalmic Emulsion, 0.05% 11/16/2022 No N/A N/A
177 Calcium Gluconate Injection, NDA 208418 213071 Nivagen Pharmaceuticals, Inc. Calcium Gluconate Injection USP, 1,000 mg per 10 mL (100 mg per mL) Single-Dose Vial 10/14/2022  Yes No 11/6/2022
176 Briviact Tablets, NDA 205836 214501 Zydus Pharmaceuticals (USA) Inc. Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg 10/3/2022 No N/A N/A
175 Phenylephrine Hydrochloride Ophthalmic Solution, NDA 207926 216859 Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% w/v (2 mL fill) 9/29/2022 Yes No 10/7/2022
174 Pathocil Capsules, NDA 050011 216845 Aurobindo Pharma USA, Inc. Dicloxacillin Sodium Capsules USP, 250 mg and 500 mg 9/23/2022 Yes No 9/30/2022
173 Timoptic in Ocudose Ophthalmic Solution, NDA 019463 216533 Ingenus Pharmaceuticals, LLC Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials 9/13/2022 No N/A N/A
172 Tazorac Gel, NDA 020600 215433 Cosette Pharmaceuticals, Inc. Tazarotene Gel, 0.05% 9/13/2022 Yes No 9/14/2022
171 Tazorac Gel, NDA 020600 214136 Cosette Pharmaceuticals, Inc. Tazarotene Gel, 0.01% 9/13/2022 Yes No 9/14/2022
170 Carafate Suspension, NDA 19183 212913 Mylan Pharmaceuticals, Inc. Sucralfate Oral Suspension, 1 g/10 mL 9/12/2022 No N/A N/A
169 Dexamethasone Tablets, ANDA 087916 216295 Amneal Pharmaceuticals LLC Dexamethasone Tablets USP, 2 mg 9/8/2022 Yes No 9/9/2022
168 Lyrica CR Tablets, NDA 209501 215577 Zydus Pharmaceuticals (USA) Inc. Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, and 330 mg
                               		 8/26/2022 No N/A N/A
167 Cetrotide Injection, NDA 021197 215737 Akorn Operating Company LLC Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose  8/12/2022 Yes No 10/24/2022
166 Divigel Gel, NDA 022038 211783 Chemo Research S.L. Estradiol Gel, 0.1% 8/10/2022 Yes No 10/10/2022
165 Clindagel Gel, NDA 050782 214668 Amneal Pharmaceuticals LLC Clindamycin Phosphate Gel USP, 1% 8/5/2022 Yes No 8/5/2022
 
164 Bactroban Cream, NDA 050746 212465 Padagis Israel Pharmaceuticals Ltd. Mupirocin Cream USP, 2%
 		 8/3/2022 No N/A N/A
163 Taytulla Capsules, NDA 204426 213418 Glenmark Pharmaceuticals Limited Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg 7/27/2022 No N/A N/A
162 Vasostrict Injection, NDA 204485 211857 Amphastar Pharmaceuticals, Inc. Vasopressin Injection USP, 20 Units/mL Single-Dose Vials 7/18/2022 No N/A N/A
161 Nalfon Capsules, NDA 017604 214475 Rising Pharma Holdings, Inc. Fenoprofen Calcium Capsules USP, 400 mg 7/18/2022 Yes No 8/15/2022
160 Atropine Sulfate Ophthalmic Solution USP, NDA 206289 214752 Amneal Pharmaceuticals LLC Atropine Sulfate Ophthalmic Solution USP, 1% 7/14/2022 No N/A N/A
159 Isordil Tablets, NDA 012093 215723 Rubicon Research Private Limited Isosorbide Dinitrate Tablets USP, 40 mg 7/8/2022 No N/A N/A
158 Neostigmine Methylsulfate Injection USP, NDA 203629 216291 Dr. Reddy's Laboratories Limited Neostigmine Methylsulfate Injection USP, 3 mg/3 mL (1 mg/mL) Single-Dose Prefilled Syringes 7/6/2022 Yes No 7/25/2022
157 Plasma-Lyte 148 Injection, NDA 017378 215370 Fresenius Kabi USA, LLC Multiple Electrolytes Injection Type 1 USP, pH 5.5, Single-Dose Containers 6/29/2022 Yes Yes N/A
156 Carbaglu Tablets for Oral Suspension, NDA 022562 213395 Navinta LLC Carglumic Acid Tablets for Oral Suspension, 200 mg 6/22/2022 No N/A N/A
155 Narcan Nasal Spray, NDA 208411 211951 Padagis Israel Pharmaceuticals Ltd. Naloxone Hydrochloride Nasal Spray, 4 mg/spray 6/21/2022 No N/A N/A
154 Infants’ Advil Concentrated Drops, NDA 020812  214071 Strides Pharma Inc. Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) 6/9/2022 Yes Yes N/A
153 Plasma-Lyte A Injection pH 7.4, NDA 017378  215371 Fresenius Kabi USA, LLC Multiple Electrolytes Injection Type 1 USP, pH 7.4, Single-Dose Containers 6/8/2022 Yes Yes N/A
152 Epiduo Forte Topical Gel, NDA 207917 214553 Zydus Pharmaceuticals (USA) Inc. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 6/3/2022 No N/A N/A
151 Epiduo Forte Topical Gel, NDA 207917 212464 Padagis US, LLC Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 5/31/2022 No N/A N/A
150  Atropine Sulfate Injection, NDA  214652
 		 216120 American Regent, Inc.   Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials 5/26/2022 Yes No 8/2/2022
 
149 Brovana Inhalation Solution, NDA 021912 215385 Sun Pharmaceutical Industries Ltd Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vial 5/26/2022 No N/A N/A
148 Alimta, NDA 021462 214073 Zydus Pharmaceuticals (USA) Inc. Pemetrexed for Injection USP, 1000 mg/vial
 		 5/25/2022 No N/A N/A
147 Lexiscan Injection, NDA 022161 214252 International Medication Systems, Limited Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe 5/23/2022 No N/A N/A
146 Visipaque, NDA 20351 214271 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Iodixanol Injection USP, 270 mg Iodine/mL and 320 mg Iodine/mL Single Dose Bottles     5/19/2022 Yes No 7/13/2022
145 Pentasa Extended-Release Capsules, NDA 020049 214585 Sun Pharmaceutical Industries Inc. Mesalamine Extended Release Capsules USP, 500 mg 5/11/2022 Yes No

5/18/2022
144 Brovana Inhalation Solution, NDA 021912 214779 Alembic Pharmaceuticals Limited Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial 5/10/2022 No N/A N/A
143 Zinc Sulfate Injection USP, NDA 209377 216249 Gland Pharma Limited Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) 5/3/2022 Yes No 6/27/2022 (30mg/10mL (3 mg/mL))
142 Targretin Gel, NDA 021056 215398 Amneal Pharmaceuticals LLC Bexarotene Gel, 1% 4/27/2022 Yes No 5/17/2022
141 AquaMEPHYTON Injection, NDA 012223 214596 Cipla Limited Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Vials 4/22/2022 Yes No 5/3/2022
140 AquaMEPHYTON Injection, NDA 012223 212424 Cipla Limited Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Ampules 4/22/2022 Yes   5/3/2022 (by ANDA 214596)
139 Sinequan Capsules, NDA 016798 213796 Edenbridge Pharmaceuticals, LLC Doxepin Hydrochloride Capsules USP, 150 mg 4/19/2022  Yes No 5/2/2022
138 Mestinon Oral Solution, NDA 015193 212405 Milla Pharmaceuticals, Inc Pyridostigmine Bromide Solution USP, 60 mg/5 mL 4/19/2022  No  N/A N/A
137 Lexiscan Injection, NDA 022161 213210 Dr. Reddy's Laboratories, Inc. Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe 4/11/2022 No N/A N/A
136 Ganirelix Acetate Injection, NDA 021057 212613 Amphastar Pharmaceuticals, Inc. Ganirelix Acetate Injection, 250 mcg/0.5 mL Prefilled Syringe 4/7/2022 No N/A N/A
135 Noxafil Delayed-Released Tablets, NDA 205053 212500 Dr. Reddy's Laboratories, Inc. Posaconazole Delayed-Release Tablets, 100 mg 4/7/2022 No N/A N/A
134 Butalbital and Acetaminophen Tablets, ANDA 89988 214088 Havix Group Inc. Butalbital and Acetaminophen Tablets, 25 mg/325 mg 4/7/2022 Yes Yes N/A
133 BiDil Tablets, NDA 020727 215586 RiconPharma LLC Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg 4/6/2022 Yes No 4/12/2022
132 Revatio for Oral Suspension, NDA 203109 211638 Lupin Pharmaceuticals, Inc. Sildenafil for Oral Suspension, 10 mg/mL 3/23/2022 No N/A N/A
131 Carafate Oral Suspension, NDA 019183 211884 VistaPharm, Inc. Sucralfate Oral Suspension, 1 g/10 mL 3/15/2022 Yes No 3/15/2022
130 Brovana Inhalation Solution, NDA 021912 214736 VistaPharm, Inc. Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL, Unit-Dose Vial 3/2/2022 No N/A N/A
129 Apokyn Injection NDA 021264 212025 Sage Chemical, Inc. Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use Glass Cartridge 2/23/2022 Yes No 2/25/2022
128 Veltin Gel, NDA 050803 212845 Solaris Pharma Corporation Clindamycin Phosphate and Tretinoin Gel, 1.2%/0.025% 2/10/2022 Yes No 4/12/2022
127 Lanoxin Tablets, NDA 020405 214982 Aurobindo Pharma Limited Digoxin Tablets USP, 0.0625 mg 2/8/2022 Yes No 2/17/2022
126 Revex, NDA 020459 212955 Purdue Pharma L.P. Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL) Single-Dose Vials 2/8/2022 Yes Relinquished N/A
125 Cystadane Powder, NDA 020576 210508 Lukare Medical, LLC Betaine Anhydrous for Oral Solution, 180 grams/bottle 1/28/2022 No N/A N/A
124 Atropine Sulfate Injection, NDA 021146 215342 Amneal EU, Limited Atropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL) Single-Dose Syringe 1/26/2022 No N/A N/A
123 Monurol Granules, NDA 050717 211881 Cipla USA, Inc. Fosfomycin Tromethamine Suspension 3 g (base) Single-Dose Sachet 1/26/2022 No N/A N/A
122

Migranal Nasal Spray, NDA 020148

 214105  Amneal Pharmaceuticals LLC Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) 1/4/2022   No N/A N/A
121 AmBisome Liposome for Injection, NDA 050740 212514 Sun Pharmaceutical Industries Inc. Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial 12/14/2021 Yes No 2/15/2022
120 Timoptic Ophthalmic Solution in Ocudose, NDA 019463 212592 Pharmaceutical Project Solutions, Inc. Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials 12/13/2021 Yes No 2/26/2022
119 Atropine Sulfate Injection, NDA 209260 213561 Hikma Pharmaceuticals USA Inc.

Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multi-Dose Vial

 12/1/2021 No N/A  N/A
118 Atropine Sulfate, NDA 206289 215624 Apotex Atropine Sulfate Ophthalmic Solution, USP 1% 11/26/2021 Yes No   11/26/2021
117 Cystadane, NDA 20576 214864 Novitium Pharma Betaine Anhydrous for Oral Solution, 180 grams/bottle 11/23/2021 Yes No 2/3/2022
116 Isordil, NDA 012093 211290 Par Pharmaceutical, Inc. Isosorbide Dinitrate Tablets USP, 40 mg 11/23/2021 Yes No 12/21/2021
115 Perforomist Inhalation Solution, NDA 022007 215078 Alembic Pharmaceuticals Limited Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial 11/22/2021 No N/A No
114 Revatio, NDA 203109 212312 Tris Pharma, Inc. Sildenafil for Oral Suspension, 10 mg/mL 11/17/2021 No N/A No
113 Arranon, NDA 021877 215037 Zydus Pharmaceuticals (USA) Inc. Nelarabine Injection, 250 mg/50 mL (5 mg/mL), SingleDose Vial 11/17/2021 Yes No 11/23/2021
112 Bactroban 2% Cream, NDA 050746 213053 Aleor Dermaceuticals Limited Mupirocin Cream USP, 2% 11/16/2021 Yes No   12/29/2021
111   Librax Capsules, NDA 012750 211476 Teva Pharmaceuticals USA, Inc.   Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 11/2/2021  No N/A N/A
110 Prexxartan, NDA 209139 214102  Novitium Pharma, LLC Valsartan Oral Solution, 20 mg/5 mL (4 mg/mL) 11/2/2021 Yes Yes N/A
109 Monurol, NDA 050171 214554 Alkem Laboratories Limited Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet 10/21/2021 No   N/A
108 Decadron Tablets, NDA 011664 215106 Amneal EU, Limited Dexamethasone Tablets USP, 4 mg and 6 mg 10/14/2021 Yes No 4 mg - 10/22/2021; 6 mg - 10/21/2021
107 Carbaglu Tablets for Oral Suspension, NDA 016636 213729 Novitium Pharma, LLC Carglumic Acid Tablets for Oral Suspension, 200 mg 10/13/2021 Yes N0 12/20/2021
106 Mexitil Capsules, NDA 018873 214089 Aavis Pharmaceuticals Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg 10/1/2021 No N/A N/A
105 Zomig Nasal Spray, NDA 021450 212469 Padagis US, LLC Zolmitriptan Nasal Spray USP, 2.5 mg/spray and 5 mg/spray 9/30/2021 No N/A N/A
104 Absorica Capsules, NDA 021951 212333 Upsher-Smith Laboratories, LLC Isotretinoin Capsules USP, 10 mg, 20 mg, and 30 mg 9/21/2021 No  N/A N/A
103 Quinaglute ER Tablets, NDA 016647 212589 Eywa Pharma, Inc. Quinidine Gluconate Extended-Release Tablets USP, 324 mg 9/17/2021 Yes Yes N/A
102 Paxil Oral Suspension, NDA 020710 215003 Novitium Pharma LLC Paroxetine Oral Suspension, 10 mg (base)/5 mL 9/3/2021 Yes No 9/13/2021
101 Ortho Evra, NDA 021180 213977 Teva Pharmaceuticals USA, Inc. Onsura (Norelgestromin and Ethinyl Estradiol Transdermal
System), 150 mcg/35 mcg per day		 8/25/2021 No N/A N/A
100 Aramine, NDA 009509 211304 Slayback Pharma LLC Metaraminol Bitartrate Injection USP, 100 mg (base)/10 mL (10 mg (base)/mL), Multi-Dose Vial 8/24/2021 Yes Yes N/A
99 Cuprimine, NDA 019853 213293 InvaGen Pharmaceuticals, Inc. Penicillamine Capsules USP, 250 mg 8/19/2021 No N/A N/A
98 Clindagel, NDA 050782 212842 Solaris Pharma Corporation Clindamycin Phosphate Gel USP, 1% 8/13/2021 No N/A N/A
97 Loperamide Hydrochloride Capsules, NDA 21855  213070 Strides Pharma, Inc. Loperamide Hydrochloride Capsules USP, 2 mg (OTC) 8/11/2021 Yes No 10/22/2021
96 Paraflex Tablets, NDA 011300 215158 Havix Group, Inc. Chlorzoxazone Tablets USP, 250 mg 7/29/2021 Yes No 9/30/2021
95 Daraprim Tablets, NDA 008578 211271 Alvogen Pyrimethamine Tablets USP, 25 mg 7/27/2021 Yes No 10/4/2021
94 Ery-Tabs, ANDA 062298 211975 Torrent Pharma Inc. Erythromycin Delayed-Release Tablets USP, 250 mg and 500 mg 7/26/2021 Yes No 10/4/2021
93 Atropine Sulfate Injection USP, NDA 021146 212868 Accord Healthcare Inc. Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe 7/26/2021 Yes No 7/30/2021
92 Taytulla Capsules, NDA 204426 214292 Amneal Pharmaceuticals Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg 7/20/2021 No N/A N/A
91 Theophylline Extended-Release Tablets, ANDA 90430 212184 Glenmark Pharmaceuticals Limited Theophylline Extended-Release Tablets, 450 mg 6/3/2021 Yes No 6/11/2021
90 Thorazine, NDA 009149 214542 Genus Lifesciences Inc. Chlorpromazine Hydrochloride Oral Concentrate USP, 30 mg/mL and 100 mg/mL 6/2/2021 Yes No 8/2/2021
89 Miacalcin Injection, NDA 017808 212416 Custopharm, Inc. Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial 5/14/2021 Yes No 5/14/2021
88 Revatio for Oral Suspension, NDA 203109 213014 Hetero Labs Limited Sildenafil for Oral Suspension, 10 mg/mL 5/11/2021 No N/A N/A
87 Librax Capsules, NDA 012750 214698 Dr. Reddy's Laboratories Limited Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 5/10/2021 No N/A N/A
86 Sodium Acetate Injection USP, NDA 018893 214805 Milla Pharmaceuticals, Inc. Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials 5/4/2021 Yes No 7/7/2021
85 Thiola, NDA 019569 214326 Teva Pharmaceuticals USA, Inc. Tiopronin Tablets, 100 mg 4/26/2021 No N/A N/A
84 Librax Capsules, NDA 012750 214065 Alkem Laboratories Limited Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 4/26/2021 No N/A N/A
83 Bentyl, NDA 007961 214721 Novitium Pharma LLC Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL 4/23/2021 No N/A N/A
82 Foscavir Injection, NDA 020068 213001 Gland Pharma Limited Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) 4/21/2021 Yes No 7/1/2021
81 Thorazine Tablets, NDA 009149 212144 Glenmark Pharmaceuticals Limited Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg 3/23/2021 Yes No 3/24/2021
80 Cardizem SR Extended-Release Capsules, NDA 019471 212317 Glenmark Pharmaceuticals Limited Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg 3/22/2021 Yes No 3/30/2021
79 Atropine Sulfate Injection NDA 209260 213424 Accord Healthcare Inc. Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial 3/19/2021 Yes No 3/25/2021
78 Lotemax, NDA 020583 212450 Sun Pharmaceutical Industries Inc. Loteprednol Etabonate Ophthalmic Suspension, 0.5% 2/26/2021 Yes No 5/6/2021
77 Ortho Evra, NDA 021180 213950  Amneal Norelgestromin and Ethinyl Estradiol Transdermal System, 150/35 mcg per day 2/25/2021  Yes No 2/26/2021
76 Northera NDA 203202 211818 Zydus Pharmaceuticals (USA) Inc. Droxidopa Capsules, 100 mg, 200 mg, 300 mg 2/18/2021  No N/A N/A
75 Lotemax, NDA 202872 212080 Akorn Operating Company LLC Loteprednol Etabonate Ophthalmic Gel, 0.5% 2/10/2021  No N/A N/A
74 Jadenu, NDA 207968 214194 Amneal Deferasirox Oral Granules, 180 mg and 360 mg 2/9/2021  No N/A N/A
73 Kenalog, NDA 011600 212460  Perrigo Israel Pharmaceuticals Ltd.  Triamcinolone Acetonide Ointment USP, 0.05%  2/5/2021  No N/A N/A
72 Sabril, NDA 020427 211539 Dr. Reddy's Laboratories Limited  Vigabatrin Tablets USP, 500 mg  1/29/2021  Yes  No  2/1/2021
71 Eveko, NDA 209905 212186 Glemark Pharmaceuticals Limited Amphetamine Sulfate Tablets USP, 5 mg and 10 mg 1/27/2021  No N/A N/A
70 Mexitil, NDA 018873 214352 RiconPharma LLC Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg 1/25/2021 No N/A N/A
69 Argatroban Injection, NDA 203049 214235 Caplin Steriles Limited Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial 1/21/2021 Yes Yes N/A
68 Narcan, NDA 016636 213279 Aurobindo Pharma Limited Naloxone Hydrochloride Injection USP, 2 mg/mL (1 mg/mL) prefilled Syringes 1/14/2021 No N/A N/A
67 Taytulla, NDA 204426 212706 Slayback Pharma LLC Merzee (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg) 12/18/2020 Yes No 1/18/2021
66 Jublia Topical Solution, NDA 203567 211827 Teva Pharmaceuticals USA, Inc.
Efinaconazole Topical Solution, 10%
12/16/2020 No N/A N/A
65 Jublia Topical Solution, NDA 203567 211851 Perrigo Pharma International DAC Efinaconazole Topical Solution, 10% 12/16/2020 NO N/A N/A
64 Amicar, NDA 015197 211629 ANI Pharmaceuticals, Inc. Aminocaproic Acid Tablets USP, 500 mg 12/14/2020 No N/A N/A
63 Morphine Sulfate Tablets, NDA 022207 212451 Alkem Laboratories Morphine Sulfate Tablets, 15 mg and 30 mg 12/3/2020 Yes No 2/11/2021
62 Depen Tablets, NDA 019854 212933 Lupin Limited Penicillamine Tablets USP, 250 mg 11/30/2020 No N/A N/A
61 Alinia Tablets, NDA 021497 213820 Rising Pharma Holding, Inc. Nitazoxanide Tablets, 500 mg 11/27/2020 Yes No 12/7/2020
60 Kenalog, NDA 011600 213619 Cintex Services, LLC Triamcinolone Acetonide Ointment USP, 0.05% 11/10/2020  No N/A N/A
59 Parafon Forte DSC Tablets, NDA 011529 212743 Par Pharmaceutical, Inc. Chlorzoxazone Tablets USP, 750 mg 11/2/2020 No N/A N/A
58 Timoptic-XE, NDA 020330 212942 Alembic Pharmaceuticals Limited Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% 10/22/2020 Yes No 11/25/2020
57 Librax Capsules, NDA 012750 213530 ECI Pharmaceuticals, LLC Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 10/20/2020 Yes No 10/26/2020
56 Kerydin 5% Topical Solution, NDA 204427 211848 Perrigo Pharma International DAC Tavaborole Topical Solution, 5% 10/13/2020 No N/A N/A
55 Monurol, NDA 050717 212548 Xiromed Pharma Espana, S.L. Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet 10/6/2020 Yes No 10/6/2020
54 Firazyr Injection, NDA 022150 213054 Dr. Reddy's Laboratories Limited Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Pre-Filled Syringe 10/5/2020 No N/A N/A
53 Claritin RediTabs, NDA 021993 212795 Tenshi Kaizen Private Limited. Loratadine Orally Disintegrating Tablets USP, 5 mg 9/18/2020 Yes Yes N/A
52 Parafon Forte DSC Tablets, NDA 011529 212053 i3 Pharmaceuticals Chlorzoxazone Tablets USP, 375 mg and 750 mg 9/14/2020 No N/A N/A
51 Taclonex, NDA 22185 212367 Perrigo Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% 9/11/2020 No N/A N/A
50 Nascobal, NDA 21642 212458 Perrigo Cyanocobalamin Nasal Solution 500 mcg/spray 9/9/2020 No N/A N/A
49 Daptomycin, NDA 208385  211403 Dr. Reddy's Laboratories Inc. Daptomycin for Injection, 350 mg per vial (single-dose vial) 
 		 8/31/2020  No  N/A N/A
48 Revatio, NDA 203109 213041 AptaPharma, Inc. Sildenafil for Oral Suspension, 10mg/mL 8/6/2020 No N/A N/A
47 Cuprimine, NDA 019853 211867 Dr Reddy's Laboratories, Inc. Penicillamine Capsules USP, 250 mg 8/4/2020 No N/A N/A
46 Metro I.V., NDA 018900 212435 Gland Pharma Limited Metronidazole Injection USP, 500 mg/100 mL (5 mg/mL) 8/3/2020 Yes Yes N/A
45 Demser, NDA 017871 213734 Amneal Metyrosine Capsules USP, 250 mg 7/24/2020 Yes No 7/30/2020
44 Mexitil, NDA 018873 213500 CrossMedika SA Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg 7/22/2020 Yes No 7/22/2020
43 Parafon Forte DSC Tablets, NDA 011529 212898 Teva Pharmaceuticals USA, Inc. Chlorzoxazone Tablets USP, 375 mg and 750 mg 6/17/2020 No N/A N/A
42 Albenza Tablets, NDA 020666 211636 Lupin Limited Albendazole Tablets USP, 200 mg 6/10/2020 Yes Yes N/A
41 Kenalog, NDA 011600 212356 Strides Pharma Inc. Triamcinolone Acetonide Ointment USP, 0.05% 6/1/2020 No N/A N/A
40 Revatio for Oral Suspension, NDA 203109 211534 Teva Pharmaceuticals USA, Inc. Sildenafil for Oral Suspension, 10 mg/mL 5/29/2020 No N/A N/A
39 Parafon Forte DSC Tablets, NDA 011529 212185 Glenmark Pharmaceuticals Limited Chlorzoxazone Tablets USP, 375 mg and 750 mg 5/26/2020 No N/A N/A
38 Bentyl (Dicyclomine Hydrochloride), NDA 007961 212286 Hikma Pharmaceuticals USA Inc. Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL 5/22/2020 Yes No 5/22/2020
37 Migranal Nasal Spray, NDA 020148 212907 Cipla Limited Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) 5/20/2020 Yes No 5/23/2020
36 K-Dur (Potassium Chloride), NDA 019439 
 		 212861  Amneal  Potassium Chloride Extended-Release Tablets USP, 15 mEq  5/8/2020 Yes Yes N/A
35 Butrans (Buprenorphine), NDA
021306 		 211586  Amneal  Buprenorphine Transdermal System, 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour 4/14/2020  Yes (7.5 mcg/hour);
No (20 mcg/hour);
No (15 mcg/hour);
No (10 mcg/hour); No (5 mcg/hour)		 No  4/16/2020
34 Adrenalin, NDA 204640 211880 International Medication Systems, Limited Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) 4/24/2020 No N/A N/A
33 Narcan, NDA 16636  
 		 213209  Dr. Reddy's Laboratories Limited  Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL)  3/16/2020  Yes  No 3/18/2020
32 Tepadina, NDA 208264 213049 MSN Pharmaceuticals Inc. Thiotepa for Injection USP, 15mg/vial and 100 mg/vial 3/4/2020 No N/A N/A
31 Depen, NDA 19854 211497 Teva Pharmaceuticals USA, Inc. Penicillamine Tablets USP, 250mg 2/13/2020 Yes Yes N/A
30 Mestinon, NDA 15193 212702 Amneal Pyridostigmine Bromide Oral Syrup, USP 60 mg/5 mL 1/10/2020 No N/A N/A
29 Valium, NDA 016087 211998 Beloteca, Inc. Diazepam Injection USP, 50 mg/10 mL (5 mg/mL) 12/26/2019 Yes Yes N/A
28 Proglycem Oral Suspension, NDA 017453 211050 e5 Pharma, LLC Diazoxide Oral Suspension USP, 50 mg/mL, 12/20/2019 Yes No 12/20/2019
27 Triamcinolone Acetonide, ANDA 089595 212384 Encube Triamcinolone Acetonide Ointment USP, 0.05% 11/29/2019 Yes No 12/2/2019
26 Amicar, NDA 15197 212492 Amneal  Aminocaproic Acid Tablets USP, 500 mg 11/27/2019 Yes No 12/3/2019
25 Chlorzoxazone Tablets, ANDA 40861 212253 Novitium Pharma Chlorzoxazone Tablets USP, 375 mg and 750 mg 11/27/2019 Yes No 11/27/2019
24 Revatio, NDA 203109 212440 Alkem Laboratories  Sildenafil for Oral Suspension, 10 mg/mL 11/27/2019 No N/A N/A
23 Revatio, NDA 203109 212883 Ajanta Pharma Sildenafil for Oral Suspension, 10 mg/mL 11/27/2019 No N/A N/A
22 Butalbital and Acetaminophen, ANDA 207313 213115 Granules Butalbital and Acetaminophen Capsules, 50 mg/300 mg 11/25/2019 Yes No 1/30/2020
21 Eryped, NDA 050207 211991 Par Pharmaceutical Inc.  Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg /5 mL and 400 mg/ 5 mL 10/23/2019 Yes Yes (400 mg) 11/11/2019 (200 mg)
20 Rapamune, NDA 21083 211406 Apotex Sirolimus Oral Solution, 1 mg/mL 10/22/2019 No N/A N/A
19 Digoxin, NDA 21648 213000 Novitium Pharma Digoxin Oral Solution USP, 0.05 mg/mL 10/4/2019 Yes No 10/4/2019
18 Elidel, NDA 21302 211769 Glenmark Pimecrolimus Cream, 1%  8/29/2019 No N/A N/A
17 Orfadin, NDA 21232 211041 Novitium Pharma Nitisinone Capsules, 2 mg, 5 mg and 10 mg  8/26/2019 No N/A N/A
16 Amicar, NDA 15230 212780 Amneal Aminocaproic Acid Oral Solution USP, 0.25 g/mL                                                                                               8/23/2019 Yes No 8/30/2019
15 Aleve PM, NDA 205352 211830 Apotex Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220/25 mg 8/22/2019 Yes Yes N/A
14 Levocarnitine, NDA 19257 211676 Novitium Pharma Levocarnitine Sugar Free Oral Solution, 1 g/mL  8/14/2019 Yes No 10/16/2019
13 Daptomycin, NDA 208385 212667 Accord Daptomycin for Injection, 350 mg/vial 7/12/2019 Yes No 7/16/2019
12 Hemabate, NDA 17989 211941 Dr. Reddy's Laboratories Carboprost Tromethamine Injection, 250 mcg/mL 7/2/2019 Yes No 7/2/2019
11 Cuprimine, NDA 19853 210976 Watson Penicillamine Capsule, 250 mg 6/24/2019 Yes No 6/25/2019
10 Revatio, NDA 203109 212260 Novitium Pharma Sildenafil Citrate for Oral Suspension, 10 mg/mL 5/31/2019 Yes No 5/31/2019
9 Navane, NDA 16584 211642 Novitium Pharma Thiothixene Capsules, 1 mg, 2 mg, 5 mg and 10 mg  4/5/2019 Yes No 4/5/2019
8 Methergine, NDA 06035 211455 Teva Methylergonovine Maleate Tablets, 0.2 mg 3/20/2019 No N/A N/A
7 Mestinon, NDA 15193 211694 Novitium Pharma Pyridostigmine Bromide Oral Syrup, 60 mg/5 mL 3/8/2019 Yes No 3/8/2019
6 Rapamune, NDA 21083 211040 Novitium Pharma Sirolimus Solution, 1 mg/mL 1/28/2019 No N/A N/A
5 Westcort, NDA 01872 211750 Glenmark Hydrocortisone Valerate Ointment, 0.2 % 12/14/2018 Yes No 1/17/2019
4 Levo-Dromoran, NDA 08720 211484 Virtus Levorphanol Tartrate Tablet, 2 mg 12/13/2018 Yes No 12/13/2018
3 Amphetamine, ANDA 200166 211139 Amneal Amphetamine Sulfate Tablet, 5 mg and 10 mg 9/26/2018 Yes No 9/27/2018 (5 mg)
10/1/2018 (10 mg)
2 Methergine, NDA 06035 211483 Amneal  Methylergonovine Maleate Tablets, 0.2 mg 9/10/2018 Yes No 9/21/2018
1 Potassium Chloride, NDA 206814 211067 Apotex Potassium Chloride Oral Solution, 20 mEq/15 mL and 40 mEq/15 mL 8/8/2018 Yes No 8/29/2018 (20 mg)
9/7/2018 (40 mg) 
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