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Drugs@FDA: FDA-Approved Drugs

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

May 23, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Mesalamine
ANDA #208954
Mesalamine Capsule, Extended Release; Oral SUPPL-4 Zydus Pharms Labeling Approved
Nicotrol
NDA #020385
Nicotine Spray, Metered; Nasal SUPPL-12 Pfizer Inc Labeling Approved
Nicotrol
NDA #020714
Nicotine Inhalant; Oral SUPPL-19 Pfizer Labeling Approved
Rivaroxaban
ANDA #218768
Rivaroxaban Tablet; Oral ORIG-1 Invagen Pharma Inc Tentative Approval
Sumatriptan Succinate
ANDA #202758
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-8 Eugia Pharma Labeling Approved
Sumatriptan Succinate
ANDA #202758
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-8 Eugia Pharma Labeling Approved
Sumatriptan Succinate
ANDA #202758
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-8 Eugia Pharma Labeling Approved

May 22, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cefepime Hydrochloride
ANDA #214402
Cefepime Hydrochloride Injectable; Injection ORIG-1 Hikma Approved
Dabigatran Etexilate Mesylate
ANDA #213879
Dabigatran Etexilate Mesylate Capsule; Oral ORIG-1 Msn Approved
Dabigatran Etexilate Mesylate
ANDA #213879
Dabigatran Etexilate Mesylate Capsule; Oral ORIG-2 Msn Tentative Approval
Hepzato
NDA #201848
Melphalan Hydrochloride Powder; Intra-Arterial SUPPL-3 Delcath Systems Inc Labeling Approved
Irbesartan
ANDA #211056
Irbesartan Tablet; Oral ORIG-1 Ipca Labs Ltd Approved
Savella
NDA #022256
Milnacipran Hydrochloride Tablet; Oral SUPPL-29 Abbvie Labeling Approved
Xyrem
NDA #021196
Sodium Oxybate Solution; Oral SUPPL-44 Jazz Pharms REMS Approved
Xywav
NDA #212690
Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate Solution; Oral SUPPL-15 Jazz REMS Approved

May 21, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #212447
Albuterol Sulfate Aerosol, Metered; Inhalation ORIG-1 Armstrong Pharms Approved
Cimerli
BLA #761165
Ranibizumab-Eqrn Injectable; Injection SUPPL-5 Coherus Biosciences Inc Bioequivalence Approved
Cyclosporine
ANDA #209811
Cyclosporine Emulsion; Ophthalmic ORIG-1 Deva Holding As Approved
Eligard Kit
NDA #021343
Leuprolide Acetate Powder; Subcutaneous SUPPL-52 Tolmar Labeling Approved
Eligard Kit
NDA #021379
Leuprolide Acetate Powder; Subcutaneous SUPPL-55 Tolmar Labeling Approved
Eligard Kit
NDA #021488
Leuprolide Acetate Powder; Subcutaneous SUPPL-50 Tolmar Labeling Approved
Eligard Kit
NDA #021731
Leuprolide Acetate Powder; Subcutaneous SUPPL-52 Tolmar Labeling Approved
Lanreotide Acetate
ANDA #217193
Lanreotide Acetate Solution; Subcutaneous ORIG-1 Invagen Pharms Approved
Sucralfate
ANDA #216474
Sucralfate Suspension; Oral ORIG-1 Strides Pharma Approved
Theophylline
ANDA #218063
Theophylline Tablet, Extended Release; Oral ORIG-1 Zydus Pharms Approved

May 20, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5193 Genzyme Labeling Approved
Estradiol
ANDA #217882
Estradiol Gel; Topical ORIG-1 Novitium Pharma Tentative Approval
Hydroxychloroquine Sulfate
ANDA #210577
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-15 Amneal Pharms Co Labeling Approved
Hydroxychloroquine Sulfate
ANDA #210577
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-16 Amneal Pharms Co Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5193 Genzyme Labeling Approved
Montelukast Sodium
ANDA #078723
Montelukast Sodium Tablet, Chewable; Oral SUPPL-16 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #078723
Montelukast Sodium Tablet, Chewable; Oral SUPPL-16 Teva Pharms Labeling Approved
Opuviz
BLA #761350
Aflibercept-Yszy Injectable; Injection ORIG-1 Samsung Bioepis Co Ltd Type 3 - New Dosage Form Approved
Paliperidone Palmitate
ANDA #212290
Paliperidone Palmitate Injectable; Suspension, Extended Release ORIG-1 Mylan Pharms Inc Tentative Approval
Paliperidone Palmitate
ANDA #216228
Paliperidone Palmitate Suspension, Extended Release; Injectable ORIG-1 Mylan Pharms Inc Tentative Approval
Pazopanib Hydrochloride
ANDA #217713
Pazopanib Hydrochloride Tablet; Oral SUPPL-1 Apotex Labeling Approved
Quetiapine Fumarate
ANDA #205983
Quetiapine Fumarate Tablet; Oral ORIG-1 Ipca Labs Ltd Approved
Trazodone Hydrochloride
ANDA #211116
Trazodone Hydrochloride Tablet; Oral ORIG-1 Crossmedika Sa Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-14 Novel Labs Inc Labeling Approved
Yesafili
BLA #761274
Aflibercept-Jbvf Injectable; Injection ORIG-1 Biocon Biologics Inc Approved

May 17, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-2 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-12 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-20 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-12 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-20 Alembic Labeling Approved
Anastrozole
ANDA #078058
Anastrozole Tablet; Oral SUPPL-14 Teva Pharms Labeling Approved
Anastrozole
ANDA #078058
Anastrozole Tablet; Oral SUPPL-14 Teva Pharms Labeling Approved
Arformoterol Tartrate
ANDA #216303
Arformoterol Tartrate Solution; Inhalation ORIG-1 Cf Pharmtech Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-49 Pharmacia Labeling Approved
Deferasirox
ANDA #206585
Deferasirox Tablet, For Suspension; Oral ORIG-1 Mylan Approved
Emtricitabine and Tenofovir Alafenamide Fumarate
ANDA #214053
Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral ORIG-1 Apotex Approved
Eprontia
NDA #214679
Topiramate Solution; Oral SUPPL-7 Azurity Labeling Approved
Eprontia
NDA #214679
Topiramate Solution; Oral SUPPL-7 Azurity Labeling Approved
Frovatriptan Succinate
ANDA #211292
Frovatriptan Succinate Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Gemfibrozil
ANDA #074270
Gemfibrozil Tablet; Oral SUPPL-19 Chartwell Molecules Manufacturing (CMC) Approved
Gemfibrozil
ANDA #074270
Gemfibrozil Tablet; Oral SUPPL-19 Chartwell Molecules Manufacturing (CMC) Approved
Memantine Hydrochloride
ANDA #212947
Memantine Hydrochloride Tablet; Oral SUPPL-1 Yiling Manufacturing (CMC) Approved
Montelukast Sodium
ANDA #209011
Montelukast Sodium Tablet, Chewable; Oral SUPPL-1 Rising Labeling Approved
Montelukast Sodium
ANDA #209011
Montelukast Sodium Tablet, Chewable; Oral SUPPL-3 Rising Labeling Approved
Montelukast Sodium
ANDA #209012
Montelukast Sodium Tablet; Oral SUPPL-1 Graviti Pharms Labeling Approved
Montelukast Sodium
ANDA #209012
Montelukast Sodium Tablet; Oral SUPPL-3 Graviti Pharms Labeling Approved
Muse
NDA #020700
Alprostadil Suppository; Urethral SUPPL-32 Mylan Speciality Lp Labeling Approved
Muse
NDA #020700
Alprostadil Suppository; Urethral SUPPL-32 Mylan Speciality Lp Labeling Approved
Muse
NDA #020700
Alprostadil Suppository; Urethral SUPPL-32 Mylan Speciality Lp Labeling Approved
Pregabalin
ANDA #208113
Pregabalin Capsule; Oral ORIG-1 Indoco Approved
Syndros
NDA #205525
Dronabinol Solution; Oral SUPPL-13 Benuvia Operations Labeling Approved

May 23, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Mesalamine
ANDA #208954
Mesalamine Capsule, Extended Release; Oral SUPPL-4 Zydus Pharms Labeling Approved
Nicotrol
NDA #020385
Nicotine Spray, Metered; Nasal SUPPL-12 Pfizer Inc Labeling Approved
Nicotrol
NDA #020714
Nicotine Inhalant; Oral SUPPL-19 Pfizer Labeling Approved
Rivaroxaban
ANDA #218768
Rivaroxaban Tablet; Oral ORIG-1 Invagen Pharma Inc Tentative Approval
Sumatriptan Succinate
ANDA #202758
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-8 Eugia Pharma Labeling Approved
Sumatriptan Succinate
ANDA #202758
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-8 Eugia Pharma Labeling Approved
Sumatriptan Succinate
ANDA #202758
Sumatriptan Succinate Injectable; Subcutaneous SUPPL-8 Eugia Pharma Labeling Approved

May 22, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cefepime Hydrochloride
ANDA #214402
Cefepime Hydrochloride Injectable; Injection ORIG-1 Hikma Approved
Dabigatran Etexilate Mesylate
ANDA #213879
Dabigatran Etexilate Mesylate Capsule; Oral ORIG-1 Msn Approved
Dabigatran Etexilate Mesylate
ANDA #213879
Dabigatran Etexilate Mesylate Capsule; Oral ORIG-2 Msn Tentative Approval
Hepzato
NDA #201848
Melphalan Hydrochloride Powder; Intra-Arterial SUPPL-3 Delcath Systems Inc Labeling Approved
Irbesartan
ANDA #211056
Irbesartan Tablet; Oral ORIG-1 Ipca Labs Ltd Approved
Savella
NDA #022256
Milnacipran Hydrochloride Tablet; Oral SUPPL-29 Abbvie Labeling Approved
Xyrem
NDA #021196
Sodium Oxybate Solution; Oral SUPPL-44 Jazz Pharms REMS Approved
Xywav
NDA #212690
Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate Solution; Oral SUPPL-15 Jazz REMS Approved

May 21, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Albuterol Sulfate
ANDA #212447
Albuterol Sulfate Aerosol, Metered; Inhalation ORIG-1 Armstrong Pharms Approved
Cimerli
BLA #761165
Ranibizumab-Eqrn Injectable; Injection SUPPL-5 Coherus Biosciences Inc Bioequivalence Approved
Cyclosporine
ANDA #209811
Cyclosporine Emulsion; Ophthalmic ORIG-1 Deva Holding As Approved
Eligard Kit
NDA #021343
Leuprolide Acetate Powder; Subcutaneous SUPPL-52 Tolmar Labeling Approved
Eligard Kit
NDA #021379
Leuprolide Acetate Powder; Subcutaneous SUPPL-55 Tolmar Labeling Approved
Eligard Kit
NDA #021488
Leuprolide Acetate Powder; Subcutaneous SUPPL-50 Tolmar Labeling Approved
Eligard Kit
NDA #021731
Leuprolide Acetate Powder; Subcutaneous SUPPL-52 Tolmar Labeling Approved
Lanreotide Acetate
ANDA #217193
Lanreotide Acetate Solution; Subcutaneous ORIG-1 Invagen Pharms Approved
Sucralfate
ANDA #216474
Sucralfate Suspension; Oral ORIG-1 Strides Pharma Approved
Theophylline
ANDA #218063
Theophylline Tablet, Extended Release; Oral ORIG-1 Zydus Pharms Approved

May 20, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Campath
BLA #103948
Alemtuzumab Vial; Intravenous SUPPL-5193 Genzyme Labeling Approved
Estradiol
ANDA #217882
Estradiol Gel; Topical ORIG-1 Novitium Pharma Tentative Approval
Hydroxychloroquine Sulfate
ANDA #210577
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-15 Amneal Pharms Co Labeling Approved
Hydroxychloroquine Sulfate
ANDA #210577
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-16 Amneal Pharms Co Labeling Approved
Lemtrada
BLA #103948
Alemtuzumab Injectable; Injection SUPPL-5193 Genzyme Labeling Approved
Montelukast Sodium
ANDA #078723
Montelukast Sodium Tablet, Chewable; Oral SUPPL-16 Teva Pharms Labeling Approved
Montelukast Sodium
ANDA #078723
Montelukast Sodium Tablet, Chewable; Oral SUPPL-16 Teva Pharms Labeling Approved
Opuviz
BLA #761350
Aflibercept-Yszy Injectable; Injection ORIG-1 Samsung Bioepis Co Ltd Type 3 - New Dosage Form Approved
Paliperidone Palmitate
ANDA #212290
Paliperidone Palmitate Injectable; Suspension, Extended Release ORIG-1 Mylan Pharms Inc Tentative Approval
Paliperidone Palmitate
ANDA #216228
Paliperidone Palmitate Suspension, Extended Release; Injectable ORIG-1 Mylan Pharms Inc Tentative Approval
Pazopanib Hydrochloride
ANDA #217713
Pazopanib Hydrochloride Tablet; Oral SUPPL-1 Apotex Labeling Approved
Quetiapine Fumarate
ANDA #205983
Quetiapine Fumarate Tablet; Oral ORIG-1 Ipca Labs Ltd Approved
Trazodone Hydrochloride
ANDA #211116
Trazodone Hydrochloride Tablet; Oral ORIG-1 Crossmedika Sa Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-14 Novel Labs Inc Labeling Approved
Yesafili
BLA #761274
Aflibercept-Jbvf Injectable; Injection ORIG-1 Biocon Biologics Inc Approved

May 17, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-2 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-12 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-20 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-12 Alembic Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202713
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-20 Alembic Labeling Approved
Anastrozole
ANDA #078058
Anastrozole Tablet; Oral SUPPL-14 Teva Pharms Labeling Approved
Anastrozole
ANDA #078058
Anastrozole Tablet; Oral SUPPL-14 Teva Pharms Labeling Approved
Arformoterol Tartrate
ANDA #216303
Arformoterol Tartrate Solution; Inhalation ORIG-1 Cf Pharmtech Approved
Caduet
NDA #021540
Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-49 Pharmacia Labeling Approved
Deferasirox
ANDA #206585
Deferasirox Tablet, For Suspension; Oral ORIG-1 Mylan Approved
Emtricitabine and Tenofovir Alafenamide Fumarate
ANDA #214053
Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral ORIG-1 Apotex Approved
Eprontia
NDA #214679
Topiramate Solution; Oral SUPPL-7 Azurity Labeling Approved
Eprontia
NDA #214679
Topiramate Solution; Oral SUPPL-7 Azurity Labeling Approved
Frovatriptan Succinate
ANDA #211292
Frovatriptan Succinate Tablet; Oral SUPPL-4 Amneal Pharms Co Labeling Approved
Gemfibrozil
ANDA #074270
Gemfibrozil Tablet; Oral SUPPL-19 Chartwell Molecules Manufacturing (CMC) Approved
Gemfibrozil
ANDA #074270
Gemfibrozil Tablet; Oral SUPPL-19 Chartwell Molecules Manufacturing (CMC) Approved
Memantine Hydrochloride
ANDA #212947
Memantine Hydrochloride Tablet; Oral SUPPL-1 Yiling Manufacturing (CMC) Approved
Montelukast Sodium
ANDA #209011
Montelukast Sodium Tablet, Chewable; Oral SUPPL-1 Rising Labeling Approved
Montelukast Sodium
ANDA #209011
Montelukast Sodium Tablet, Chewable; Oral SUPPL-3 Rising Labeling Approved
Montelukast Sodium
ANDA #209012
Montelukast Sodium Tablet; Oral SUPPL-1 Graviti Pharms Labeling Approved
Montelukast Sodium
ANDA #209012
Montelukast Sodium Tablet; Oral SUPPL-3 Graviti Pharms Labeling Approved
Muse
NDA #020700
Alprostadil Suppository; Urethral SUPPL-32 Mylan Speciality Lp Labeling Approved
Muse
NDA #020700
Alprostadil Suppository; Urethral SUPPL-32 Mylan Speciality Lp Labeling Approved
Muse
NDA #020700
Alprostadil Suppository; Urethral SUPPL-32 Mylan Speciality Lp Labeling Approved
Pregabalin
ANDA #208113
Pregabalin Capsule; Oral ORIG-1 Indoco Approved
Syndros
NDA #205525
Dronabinol Solution; Oral SUPPL-13 Benuvia Operations Labeling Approved

May 16, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Azacitidine
ANDA #212580
Azacitidine Powder; Intravenous, Subcutaneous ORIG-1 Msn Labs Pvt Ltd Approved
Benlysta
BLA #125370
Belimumab Injectable; Injection SUPPL-81 Human Genome Sciences Inc. Labeling Approved
Benlysta
BLA #761043
Belimumab Injectable; Injection SUPPL-27 Glaxosmithkline Llc Efficacy Approved
Brimonidine Tartrate and Timolol Maleate
ANDA #214987
Brimonidine Tartrate; Timolol Maleate Solution/Drops; Ophthalmic ORIG-1 Glenmark Pharms Ltd Approved
Cyclosporine
ANDA #216046
Cyclosporine Capsule; Oral SUPPL-7 Strides Pharma Labeling Approved
Eohilia
NDA #213976
Budesonide Suspension; Oral SUPPL-1 Takeda Pharms Usa Labeling Approved
Eohilia
NDA #213976
Budesonide Suspension; Oral SUPPL-1 Takeda Pharms Usa Labeling Approved
Eohilia
NDA #213976
Budesonide Suspension; Oral SUPPL-1 Takeda Pharms Usa Labeling Approved
Imdelltra
BLA #761344
Tarlatamab-Dlle Injectable; Injection ORIG-1 Amgen Inc Type 1 - New Molecular Entity Approved
Irinotecan Hydrochloride
ANDA #078589
Irinotecan Hydrochloride Injectable; Injection SUPPL-13 Actavis Totowa Labeling Approved
Irinotecan Hydrochloride
ANDA #078589
Irinotecan Hydrochloride Injectable; Injection SUPPL-13 Actavis Totowa Labeling Approved
Methotrexate Sodium
ANDA #216453
Methotrexate Sodium Tablet; Oral ORIG-1 Elite Labs Inc Approved
Mitigare
NDA #204820
Colchicine Capsule; Oral SUPPL-6 Hikma Intl Pharms Labeling Approved
Reblozyl
BLA #761136
Luspatercept-Aamt Powder; Subcutaneous SUPPL-10 Celgene Corp Labeling Approved
Temozolomide
ANDA #204159
Temozolomide Capsule; Oral SUPPL-3 Apotex Labeling Approved

May 15, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #214282
Acetazolamide Tablet; Oral SUPPL-18 Mankind Pharma Manufacturing (CMC) Approved
Acetazolamide
ANDA #214282
Acetazolamide Tablet; Oral SUPPL-18 Mankind Pharma Manufacturing (CMC) Approved
Clobazam
ANDA #209853
Clobazam Tablet; Oral SUPPL-3 Apotex Labeling Approved
Clobazam
ANDA #210545
Clobazam Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #210545
Clobazam Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #210545
Clobazam Tablet; Oral SUPPL-5 Lupin Ltd Labeling Approved
Clobazam
ANDA #214404
Clobazam Suspension; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Clobazam
ANDA #214404
Clobazam Suspension; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved
Ketorolac Tromethamine
ANDA #078721
Ketorolac Tromethamine Solution/Drops; Ophthalmic SUPPL-4 Sandoz Labeling Approved
Lacosamide
ANDA #215154
Lacosamide Solution; Oral ORIG-1 Chartwell Rx Approved
Methylphenidate Hydrochloride
ANDA #207515
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Amneal Pharms Labeling Approved
Methylphenidate Hydrochloride
ANDA #207515
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Amneal Pharms Labeling Approved
Methylphenidate Hydrochloride
ANDA #207515
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Amneal Pharms Labeling Approved
Methylphenidate Hydrochloride
ANDA #207515
Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-17 Amneal Pharms Labeling Approved
Nadolol
ANDA #210955
Nadolol Tablet; Oral SUPPL-5 Beximco Pharms Usa Labeling Approved
Nadolol
ANDA #210955
Nadolol Tablet; Oral SUPPL-5 Beximco Pharms Usa Labeling Approved
Nadolol
ANDA #210955
Nadolol Tablet; Oral SUPPL-5 Beximco Pharms Usa Labeling Approved
Sotalol Hydrochloride
ANDA #075429
Sotalol Hydrochloride Tablet; Oral SUPPL-30 Teva Labeling Approved
Sotalol Hydrochloride
ANDA #075429
Sotalol Hydrochloride Tablet; Oral SUPPL-30 Teva Labeling Approved
Temozolomide
ANDA #201528
Temozolomide Capsule; Oral SUPPL-8 Accord Hlthcare Labeling Approved
Temozolomide
ANDA #203490
Temozolomide Capsule; Oral SUPPL-12 Ani Pharms Labeling Approved
Volnea
ANDA #202689
Desogestrel; Ethinyl Estradiol Tablet; Oral-28 SUPPL-6 Xiromed Labeling Approved

May 14, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #218023
Acetazolamide Tablet; Oral ORIG-1 Epic Pharma Llc Approved
Aurlumyn
NDA #217933
Iloprost Solution; Intravenous SUPPL-1 Eicos Sci Labeling Approved
Difluprednate
ANDA #207284
Difluprednate Emulsion; Ophthalmic ORIG-1 Epic Pharma Llc Approved
Fingolimod Hydrochloride
ANDA #207939
Fingolimod Hydrochloride Capsule; Oral SUPPL-10 Hec Pharm Co Ltd Labeling Approved
Fingolimod Hydrochloride
ANDA #207939
Fingolimod Hydrochloride Capsule; Oral SUPPL-12 Hec Pharm Co Ltd Labeling Approved
Lansoprazole
ANDA #202194
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-12 Dr Reddys Labs Ltd Labeling Approved
Lansoprazole
ANDA #202194
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-13 Dr Reddys Labs Ltd Labeling Approved
Likmez
NDA #216755
Metronidazole Suspension; Oral SUPPL-1 Saptalis Pharms Labeling Approved
Likmez
NDA #216755
Metronidazole Suspension; Oral SUPPL-1 Saptalis Pharms Labeling Approved
Likmez
NDA #216755
Metronidazole Suspension; Oral SUPPL-1 Saptalis Pharms Labeling Approved
Loratadine and Pseudoephedrine Sulfate
ANDA #218017
Loratadine; Pseudoephedrine Sulfate Tablet, Extended Release; Oral ORIG-1 Bionpharma Approved
Nimodipine
ANDA #216256
Nimodipine Solution; Oral ORIG-1 Amneal Pharms Llc Tentative Approval
Triglide
NDA #021350
Fenofibrate Tablet; Oral SUPPL-24 Skyepharma Ag Labeling Approved
Xeljanz
NDA #203214
Tofacitinib Citrate Tablet; Oral SUPPL-34 Pf Prism Cv Labeling Approved
Xeljanz
NDA #213082
Tofacitinib Citrate Solution; Oral SUPPL-6 Pfizer Labeling Approved
Xeljanz
NDA #213082
Tofacitinib Citrate Solution; Oral SUPPL-6 Pfizer Labeling Approved
Xeljanz Xr
NDA #208246
Tofacitinib Citrate Tablet, Extended Release; Oral SUPPL-21 Pfizer Labeling Approved

May 13, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anaprox
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-66 Atnahs Pharma Us Labeling Approved
Anaprox
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-66 Atnahs Pharma Us Labeling Approved
Anaprox Ds
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-66 Atnahs Pharma Us Labeling Approved
Anaprox Ds
NDA #018164
Naproxen Sodium Tablet; Oral SUPPL-66 Atnahs Pharma Us Labeling Approved
Diclofenac Sodium
ANDA #210893
Diclofenac Sodium Gel; Topical SUPPL-5 Padagis Israel Labeling Approved
Diclofenac Sodium
ANDA #210893
Diclofenac Sodium Gel; Topical SUPPL-2 Padagis Israel Labeling Approved
Diclofenac Sodium
ANDA #210893
Diclofenac Sodium Gel; Topical SUPPL-5 Padagis Israel Labeling Approved
Doxycycline
ANDA #065471
Doxycycline Tablet; Oral SUPPL-2 Sun Pharm Industries Labeling Approved
Ec-Naprosyn
NDA #020067
Naproxen Tablet, Delayed Release; Oral SUPPL-25 Atnahs Pharma Us Labeling Approved
Ec-Naprosyn
NDA #020067
Naproxen Tablet, Delayed Release; Oral SUPPL-25 Atnahs Pharma Us Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-8 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-17 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-19 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-21 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-6 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-8 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-17 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-19 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
ANDA #205606
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-21 Aurobindo Pharma Ltd Labeling Approved
Gonal-F Rff Redi-Ject
BLA #021684
Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-50 Emd Serono Labeling Approved
Gonal-F Rff Redi-Ject
BLA #021684
Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-50 Emd Serono Labeling Approved
Gonal-F Rff Redi-Ject
BLA #021684
Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-51 Emd Serono Labeling Approved
Meperidine Hydrochloride
ANDA #040446
Meperidine Hydrochloride Tablet; Oral SUPPL-15 Sun Pharm Inds Inc Labeling Approved
Meperidine Hydrochloride
ANDA #040446
Meperidine Hydrochloride Tablet; Oral SUPPL-15 Sun Pharm Inds Inc Labeling Approved
Methylphenidate Hydrochloride
ANDA #091601
Methylphenidate Hydrochloride Solution; Oral SUPPL-14 Tris Pharma Inc Labeling Approved
Methylphenidate Hydrochloride
ANDA #091601
Methylphenidate Hydrochloride Solution; Oral SUPPL-14 Tris Pharma Inc Labeling Approved
Mycophenolate Mofetil Hydrochloride
ANDA #203575
Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-8 Endo Operations Labeling Approved
Naprosyn
NDA #017581
Naproxen Tablet; Oral SUPPL-116 Atnahs Pharma Us Labeling Approved
Naprosyn
NDA #017581
Naproxen Tablet; Oral SUPPL-116 Atnahs Pharma Us Labeling Approved
Norepinephrine Bitartrate
ANDA #218758
Norepinephrine Bitartrate Injectable; Injection ORIG-1 Ddreg Pharma Approved
Tizanidine Hydrochloride
ANDA #213365
Tizanidine Hydrochloride Capsule; Oral ORIG-1 Appco Approved
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