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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.

February 23, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Beyfortus
BLA #761328
Nirsevimab-Alip Injectable; Injection SUPPL-7 Astrazeneca Ab Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-18 Gilead Sciences Inc Efficacy Approved
Entyvio
BLA #125476
Vedolizumab Injectable; Injection SUPPL-54 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Injection SUPPL-3 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Injection SUPPL-3 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Intravenous SUPPL-3 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Intravenous SUPPL-3 Takeda Pharms Usa Labeling Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-7 Mylan Labeling Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-7 Mylan Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-16 Amneal Pharms Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-16 Amneal Pharms Labeling Approved
Paxil Cr
NDA #020936
Paroxetine Hydrochloride Tablet, Extended Release; Oral SUPPL-65 Apotex Labeling Approved
Simlandi
BLA #761299
Adalimumab-Ryvk Injectable; Injection ORIG-1 Alvotech Usa Inc Approved

February 22, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Exblifep
NDA #216165
Cefepime;Enmetazobactam Injectable; Injection ORIG-1 Allecra Therapeutics Sas Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Imbruvica
NDA #217003
Ibrutinib Capsule; Oral SUPPL-2 Pharmacyclics Llc Labeling Approved
Imbruvica
NDA #217003
Ibrutinib Suspension; Oral SUPPL-2 Pharmacyclics Llc Labeling Approved
Imbruvica
NDA #217003
Ibrutinib Tablet; Oral SUPPL-2 Pharmacyclics Llc Labeling Approved
Intralipid 30%
NDA #019942
Soybean Oil Injectable; Injection SUPPL-22 Fresenius Labeling Approved
Lenalidomide
ANDA #217265
Lenalidomide Capsule; Oral ORIG-1 Qilu Approved
Oxcarbazepine
ANDA #217659
Oxcarbazepine Tablet, Extended Release; Oral ORIG-1 Ajanta Pharma Ltd Approved
Topiramate
ANDA #077627
Topiramate Tablet; Oral SUPPL-24 Glenmark Generics Labeling Approved

February 21, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Depo-Estradiol
ANDA #085470
Estradiol Cypionate Injectable; Injection SUPPL-27 Pfizer Labeling Approved
Gattex Kit
NDA #203441
Teduglutide Recombinant Powder; Subcutaneous SUPPL-21 Takeda Pharms Usa Manufacturing (CMC) Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-25 Amneal Pharms Labeling Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-25 Amneal Pharms Labeling Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-25 Amneal Pharms Labeling Approved
Zetia
NDA #021445
Ezetimibe Tablet; Oral SUPPL-43 Organon Labeling Approved

February 20, 2024

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate and Valsartan
ANDA #202829
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-2 Novel Labs Inc Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202829
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-3 Novel Labs Inc Labeling Approved
Dorzolamide Hydrochloride
ANDA #202053
Dorzolamide Hydrochloride Solution/Drops; Ophthalmic SUPPL-5 Indoco Labeling Approved
Dorzolamide Hydrochloride
ANDA #202053
Dorzolamide Hydrochloride Solution/Drops; Ophthalmic SUPPL-5 Indoco Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #202054
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-7 Indoco Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #202054
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-7 Indoco Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #205295
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-8 Fdc Ltd Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #205295
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-8 Fdc Ltd Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #205295
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-8 Fdc Ltd Labeling Approved
Doxylamine Succinate
ANDA #040167
Doxylamine Succinate Tablet; Oral SUPPL-51 Perrigo Manufacturing (CMC) Approved
Gabapentin
ANDA #207099
Gabapentin Capsule; Oral SUPPL-7 Graviti Pharms Labeling Approved
Guanfacine Hydrochloride
ANDA #205430
Guanfacine Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Apotex Labeling Approved
Guanfacine Hydrochloride
ANDA #205430
Guanfacine Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Apotex Labeling Approved
Lactulose
ANDA #076645
Lactulose Solution; Oral, Rectal SUPPL-7 Bajaj Labeling Approved
Lidocaine Hydrochloride Viscous
ANDA #218138
Lidocaine Hydrochloride Solution; Oral ORIG-1 Pai Holdings Pharm Approved
Mycophenolate Mofetil
ANDA #217937
Mycophenolate Mofetil Tablet; Oral ORIG-1 Aurobindo Pharma Approved
Nitroglycerin
ANDA #209779
Nitroglycerin Tablet; Sublingual SUPPL-3 Rubicon Labeling Approved
Nitroglycerin
ANDA #209779
Nitroglycerin Tablet; Sublingual SUPPL-3 Rubicon Labeling Approved
Solifenacin Succinate
ANDA #204374
Solifenacin Succinate Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Synthroid
NDA #021402
Levothyroxine Sodium Tablet; Oral SUPPL-38 Abbvie Labeling Approved
Talvey
BLA #761342
Talquetamab-Tgvs Injectable; Injection SUPPL-4 Janssen Biotech REMS Approved
Tecvayli
BLA #761291
Teclistamab-Cqyv Injectable; Injection SUPPL-3 Janssen Biotech Efficacy Approved
Teriflunomide
ANDA #209613
Teriflunomide Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Teriflunomide
ANDA #209613
Teriflunomide Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Teriflunomide
ANDA #209613
Teriflunomide Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Teriflunomide
ANDA #209700
Teriflunomide Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Teriflunomide
ANDA #209700
Teriflunomide Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Tobramycin
ANDA #207444
Tobramycin Solution/Drops; Ophthalmic SUPPL-1 Somerset Theraps Llc Labeling Approved
Tobramycin
ANDA #207444
Tobramycin Solution/Drops; Ophthalmic SUPPL-3 Somerset Theraps Llc Labeling Approved
Tobramycin
ANDA #207444
Tobramycin Solution/Drops; Ophthalmic SUPPL-4 Somerset Theraps Llc Labeling Approved
Venlafaxine Hydrochloride
ANDA #214691
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Ajanta Pharma Ltd Labeling Approved

February 23, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Beyfortus
BLA #761328
Nirsevimab-Alip Injectable; Injection SUPPL-7 Astrazeneca Ab Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-18 Gilead Sciences Inc Efficacy Approved
Entyvio
BLA #125476
Vedolizumab Injectable; Injection SUPPL-54 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Injection SUPPL-3 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Injection SUPPL-3 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Intravenous SUPPL-3 Takeda Pharms Usa Labeling Approved
Entyvio
BLA #761133
Vedolizumab Injectable; Intravenous SUPPL-3 Takeda Pharms Usa Labeling Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-7 Mylan Labeling Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-7 Mylan Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-16 Amneal Pharms Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #078267
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-16 Amneal Pharms Labeling Approved
Paxil Cr
NDA #020936
Paroxetine Hydrochloride Tablet, Extended Release; Oral SUPPL-65 Apotex Labeling Approved
Simlandi
BLA #761299
Adalimumab-Ryvk Injectable; Injection ORIG-1 Alvotech Usa Inc Approved

February 22, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Exblifep
NDA #216165
Cefepime;Enmetazobactam Injectable; Injection ORIG-1 Allecra Therapeutics Sas Type 1 - New Molecular Entity and Type 4 - New Combination Approved
Imbruvica
NDA #217003
Ibrutinib Capsule; Oral SUPPL-2 Pharmacyclics Llc Labeling Approved
Imbruvica
NDA #217003
Ibrutinib Suspension; Oral SUPPL-2 Pharmacyclics Llc Labeling Approved
Imbruvica
NDA #217003
Ibrutinib Tablet; Oral SUPPL-2 Pharmacyclics Llc Labeling Approved
Intralipid 30%
NDA #019942
Soybean Oil Injectable; Injection SUPPL-22 Fresenius Labeling Approved
Lenalidomide
ANDA #217265
Lenalidomide Capsule; Oral ORIG-1 Qilu Approved
Oxcarbazepine
ANDA #217659
Oxcarbazepine Tablet, Extended Release; Oral ORIG-1 Ajanta Pharma Ltd Approved
Topiramate
ANDA #077627
Topiramate Tablet; Oral SUPPL-24 Glenmark Generics Labeling Approved

February 21, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Depo-Estradiol
ANDA #085470
Estradiol Cypionate Injectable; Injection SUPPL-27 Pfizer Labeling Approved
Gattex Kit
NDA #203441
Teduglutide Recombinant Powder; Subcutaneous SUPPL-21 Takeda Pharms Usa Manufacturing (CMC) Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-25 Amneal Pharms Labeling Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-25 Amneal Pharms Labeling Approved
Oxycodone and Acetaminophen
ANDA #040777
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral SUPPL-25 Amneal Pharms Labeling Approved
Zetia
NDA #021445
Ezetimibe Tablet; Oral SUPPL-43 Organon Labeling Approved

February 20, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amlodipine Besylate and Valsartan
ANDA #202829
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-2 Novel Labs Inc Labeling Approved
Amlodipine Besylate and Valsartan
ANDA #202829
Amlodipine Besylate; Valsartan Tablet; Oral SUPPL-3 Novel Labs Inc Labeling Approved
Dorzolamide Hydrochloride
ANDA #202053
Dorzolamide Hydrochloride Solution/Drops; Ophthalmic SUPPL-5 Indoco Labeling Approved
Dorzolamide Hydrochloride
ANDA #202053
Dorzolamide Hydrochloride Solution/Drops; Ophthalmic SUPPL-5 Indoco Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #202054
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-7 Indoco Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #202054
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-7 Indoco Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #205295
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-8 Fdc Ltd Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #205295
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-8 Fdc Ltd Labeling Approved
Dorzolamide Hydrochloride and Timolol Maleate
ANDA #205295
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-8 Fdc Ltd Labeling Approved
Doxylamine Succinate
ANDA #040167
Doxylamine Succinate Tablet; Oral SUPPL-51 Perrigo Manufacturing (CMC) Approved
Gabapentin
ANDA #207099
Gabapentin Capsule; Oral SUPPL-7 Graviti Pharms Labeling Approved
Guanfacine Hydrochloride
ANDA #205430
Guanfacine Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Apotex Labeling Approved
Guanfacine Hydrochloride
ANDA #205430
Guanfacine Hydrochloride Tablet, Extended Release; Oral SUPPL-5 Apotex Labeling Approved
Lactulose
ANDA #076645
Lactulose Solution; Oral, Rectal SUPPL-7 Bajaj Labeling Approved
Lidocaine Hydrochloride Viscous
ANDA #218138
Lidocaine Hydrochloride Solution; Oral ORIG-1 Pai Holdings Pharm Approved
Mycophenolate Mofetil
ANDA #217937
Mycophenolate Mofetil Tablet; Oral ORIG-1 Aurobindo Pharma Approved
Nitroglycerin
ANDA #209779
Nitroglycerin Tablet; Sublingual SUPPL-3 Rubicon Labeling Approved
Nitroglycerin
ANDA #209779
Nitroglycerin Tablet; Sublingual SUPPL-3 Rubicon Labeling Approved
Solifenacin Succinate
ANDA #204374
Solifenacin Succinate Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Synthroid
NDA #021402
Levothyroxine Sodium Tablet; Oral SUPPL-38 Abbvie Labeling Approved
Talvey
BLA #761342
Talquetamab-Tgvs Injectable; Injection SUPPL-4 Janssen Biotech REMS Approved
Tecvayli
BLA #761291
Teclistamab-Cqyv Injectable; Injection SUPPL-3 Janssen Biotech Efficacy Approved
Teriflunomide
ANDA #209613
Teriflunomide Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Teriflunomide
ANDA #209613
Teriflunomide Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Teriflunomide
ANDA #209613
Teriflunomide Tablet; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Teriflunomide
ANDA #209700
Teriflunomide Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Teriflunomide
ANDA #209700
Teriflunomide Tablet; Oral SUPPL-3 Teva Pharms Usa Labeling Approved
Tobramycin
ANDA #207444
Tobramycin Solution/Drops; Ophthalmic SUPPL-1 Somerset Theraps Llc Labeling Approved
Tobramycin
ANDA #207444
Tobramycin Solution/Drops; Ophthalmic SUPPL-3 Somerset Theraps Llc Labeling Approved
Tobramycin
ANDA #207444
Tobramycin Solution/Drops; Ophthalmic SUPPL-4 Somerset Theraps Llc Labeling Approved
Venlafaxine Hydrochloride
ANDA #214691
Venlafaxine Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Ajanta Pharma Ltd Labeling Approved

February 16, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Allopurinol
ANDA #075798
Allopurinol Tablet; Oral SUPPL-23 Vintage Pharms Labeling Approved
Apixaban
ANDA #210091
Apixaban Tablet; Oral ORIG-1 Apotex Approved
Balsalazide Disodium
ANDA #077806
Balsalazide Disodium Capsule; Oral SUPPL-9 Hikma Labeling Approved
Balsalazide Disodium
ANDA #077883
Balsalazide Disodium Capsule; Oral SUPPL-13 Apotex Inc Labeling Approved
Balsalazide Disodium
ANDA #217592
Balsalazide Disodium Capsule; Oral SUPPL-1 Zydus Labeling Approved
Balsalazide Disodium
ANDA #217592
Balsalazide Disodium Capsule; Oral SUPPL-1 Zydus Labeling Approved
Brimonidine Tartrate
ANDA #216361
Brimonidine Tartrate Solution/Drops; Ophthalmic ORIG-1 Dr Reddys Labs Sa Approved
Carbamazepine
ANDA #218221
Carbamazepine Tablet; Oral ORIG-1 Bionpharma Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-2 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-1 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-2 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-3 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-4 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-1 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-2 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-3 Lupin Labeling Approved
Dimethyl Fumarate
ANDA #210226
Dimethyl Fumarate Capsule, Delayed Release; Oral SUPPL-4 Lupin Labeling Approved
Estradiol
ANDA #040114
Estradiol Tablet; Oral SUPPL-28 Dr Reddys Labs Sa Labeling Approved
Estradiol
ANDA #040275
Estradiol Tablet; Oral SUPPL-13 Epic Pharma Llc Labeling Approved
Estradiol
ANDA #209767
Estradiol Cream; Vaginal SUPPL-13 Alvogen Labeling Approved
Estradiol
ANDA #210194
Estradiol Cream; Vaginal SUPPL-11 Padagis Israel Labeling Approved
Estradiol
ANDA #212313
Estradiol Cream; Vaginal SUPPL-2 Prasco Labeling Approved
Estradiol
ANDA #212313
Estradiol Cream; Vaginal SUPPL-2 Prasco Labeling Approved
Estradiol Cypionate
ANDA #085620
Estradiol Cypionate Injectable; Injection SUPPL-20 Dr Reddys Labeling Approved
Estropipate
ANDA #081213
Estropipate Tablet; Oral SUPPL-30 Watson Labs Labeling Approved
Estropipate
ANDA #081214
Estropipate Tablet; Oral SUPPL-30 Watson Labs Labeling Approved
Estropipate
ANDA #081214
Estropipate Tablet; Oral SUPPL-30 Watson Labs Labeling Approved
Estropipate
ANDA #081215
Estropipate Tablet; Oral SUPPL-30 Watson Labs Teva Labeling Approved
Estropipate
ANDA #081215
Estropipate Tablet; Oral SUPPL-30 Watson Labs Teva Labeling Approved
Ezetimibe
ANDA #078560
Ezetimibe Tablet; Oral SUPPL-8 Glenmark Pharms Ltd Labeling Approved
Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #076766
Fluconazole Injectable; Injection SUPPL-16 Baxter Hlthcare Labeling Approved
Fyavolv
ANDA #204213
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-8 Lupin Ltd Labeling Approved
Fyavolv
ANDA #204213
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-8 Lupin Ltd Labeling Approved
Icosapent Ethyl
ANDA #216811
Icosapent Ethyl Capsule; Oral ORIG-2 Ascent Pharms Inc Approved
Irbesartan
ANDA #206194
Irbesartan Tablet; Oral SUPPL-4 Hisun Pharm Hangzhou Labeling Approved
Irbesartan
ANDA #206194
Irbesartan Tablet; Oral SUPPL-6 Hisun Pharm Hangzhou Labeling Approved
Irbesartan
ANDA #206194
Irbesartan Tablet; Oral SUPPL-7 Hisun Pharm Hangzhou Labeling Approved
Leribane
ANDA #203435
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-7 Novast Labs Labeling Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-39 Upsher Smith Labs Labeling Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-34 Upsher Smith Labs Labeling Approved
Myorisan
ANDA #076485
Isotretinoin Capsule; Oral SUPPL-39 Upsher Smith Labs Labeling Approved
Nitroglycerin
ANDA #216103
Nitroglycerin Ointment; Intra-Anal ORIG-1 Cosette Approved
Nivestym
BLA #761080
Filgrastim-Aafi Injectable; Injection SUPPL-14 Hospira Inc Labeling Approved
Nivestym
BLA #761080
Filgrastim-Aafi Vial; Single-Dose SUPPL-14 Hospira Inc Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #203038
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-8 Glenmark Generics Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #203038
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-8 Glenmark Generics Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #207259
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-4 Mylan Labs Ltd Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #207260
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-4 Mylan Labs Ltd Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #207260
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-4 Mylan Labs Ltd Labeling Approved
Ortho-Est
ANDA #089567
Estropipate Tablet; Oral SUPPL-21 Sun Pharm Inds Inc Labeling Approved
Ortho-Est
ANDA #089582
Estropipate Tablet; Oral SUPPL-20 Sun Pharm Inds Inc Labeling Approved
Ortho-Est
ANDA #089582
Estropipate Tablet; Oral SUPPL-20 Sun Pharm Inds Inc Labeling Approved
Ritonavir
ANDA #205024
Ritonavir Capsule; Oral ORIG-1 Mylan Approved
Sehippy
NDA #218328
Vortioxetine Tablet; Orally Disintegrating ORIG-1 Seasons Biotechnology (Taizhou) Co Ltd Type 2 - New Active Ingredient and Type 3 - New Dosage Form Tentative Approval
Tagrisso
NDA #208065
Osimertinib Mesylate Tablet; Oral SUPPL-30 Astrazeneca Efficacy Approved
Tobramycin
ANDA #209554
Tobramycin Solution; Inhalation SUPPL-1 Mylan Labeling Approved
Tobramycin
ANDA #209554
Tobramycin Solution; Inhalation SUPPL-1 Mylan Labeling Approved
Ursodiol
ANDA #211301
Ursodiol Capsule; Oral SUPPL-7 Amneal Pharms Co Labeling Approved
Xolair
BLA #103976
Omalizumab Syringe SUPPL-5245 Genentech Efficacy Approved
Xolair
BLA #103976
Omalizumab Vial SUPPL-5245 Genentech Efficacy Approved

February 15, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Activella
NDA #020907
Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-30 Amneal Labeling Approved
Alora
NDA #020655
Estradiol Film, Extended Release; Transdermal SUPPL-23 Abbvie Labeling Approved
Angeliq
NDA #021355
Drospirenone; Estradiol Tablet; Oral SUPPL-12 Bayer Hlthcare Labeling Approved
Bijuva
NDA #210132
Estradiol; Progesterone Capsule; Oral SUPPL-11 Mayne Pharma Labeling Approved
Bupropion Hydrochloride
ANDA #202304
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-16 Prinston Inc Labeling Approved
Bupropion Hydrochloride
ANDA #202304
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-16 Prinston Inc Labeling Approved
Cenestin
NDA #020992
Estrogens, Conjugated Synthetic A Tablet; Oral SUPPL-41 Aspen Labeling Approved
Climara
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-49 Bayer Hlthcare Labeling Approved
Climara
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-50 Bayer Hlthcare Labeling Approved
Climara Pro
NDA #021258
Estradiol; Levonorgestrel Film, Extended Release; Transdermal SUPPL-15 Bayer Hlthcare Labeling Approved
Combipatch
NDA #020870
Estradiol; Norethindrone Acetate Film, Extended Release; Transdermal SUPPL-33 Noven Pharms Inc Labeling Approved
Delestrogen
NDA #009402
Estradiol Valerate Injectable; Injection SUPPL-63 Par Sterile Products Labeling Approved
Dihydroergotamine Mesylate
ANDA #206621
Dihydroergotamine Mesylate Injectable; Injection SUPPL-2 Hikma Pharms Labeling Approved
Divigel
NDA #022038
Estradiol Gel; Transdermal SUPPL-12 Vertical Pharms Labeling Approved
Elestrin
NDA #021813
Estradiol Gel, Metered; Transdermal SUPPL-14 Mylan Speciality Lp Labeling Approved
Enhertu
BLA #761139
Fam-Trastuzumab Deruxtecan-Nxki Injectable; Injection SUPPL-26 Daiichi Sankyo Efficacy Approved
Enjuvia
NDA #021443
Estrogens, Conjugated Synthetic B Tablet; Oral SUPPL-13 Aspen Labeling Approved
Estrace
ANDA #086069
Estradiol Cream; Vaginal SUPPL-27 Allergan Labeling Approved
Estradiol
NDA #020538
Estradiol Film, Extended Release; Transdermal SUPPL-43 Sandoz Labeling Approved
Estradiol
ANDA #040197
Estradiol Tablet; Oral SUPPL-33 Barr Labs Inc Labeling Approved
Estradiol
ANDA #040197
Estradiol Tablet; Oral SUPPL-33 Barr Labs Inc Labeling Approved
Estradiol
ANDA #040326
Estradiol Tablet; Oral SUPPL-16 Mylan Labeling Approved
Estradiol
ANDA #208788
Estradiol Cream; Vaginal SUPPL-3 Mylan Labeling Approved
Estradiol
ANDA #208788
Estradiol Cream; Vaginal SUPPL-3 Mylan Labeling Approved
Estradiol
ANDA #210488
Estradiol Cream; Vaginal SUPPL-3 Teva Pharms Usa Labeling Approved
Estradiol
ANDA #210488
Estradiol Cream; Vaginal SUPPL-3 Teva Pharms Usa Labeling Approved
Estradiol and Norgestimate
ANDA #076812
Estradiol; Norgestimate Tablet; Oral SUPPL-21 Barr Labeling Approved
Estradiol and Norgestimate
ANDA #076812
Estradiol; Norgestimate Tablet; Oral SUPPL-21 Barr Labeling Approved
Estrasorb
NDA #021371
Estradiol Hemihydrate Emulsion; Topical SUPPL-10 Exeltis Usa Inc Labeling Approved
Estring
NDA #020472
Estradiol Insert, Extended Release; Vaginal SUPPL-20 Pfizer Labeling Approved
Estrogel
NDA #021166
Estradiol Gel, Metered; Transdermal SUPPL-19 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel, Metered; Transdermal SUPPL-19 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel; Topical SUPPL-19 Ascend Theraps Us Labeling Approved
Estrogel
NDA #021166
Estradiol Gel; Topical SUPPL-19 Ascend Theraps Us Labeling Approved
Estropipate
ANDA #040359
Estropipate Tablet; Oral SUPPL-6 Mylan Labeling Approved
Estropipate
ANDA #040359
Estropipate Tablet; Oral SUPPL-6 Mylan Labeling Approved
Estropipate
ANDA #040359
Estropipate Tablet; Oral SUPPL-6 Mylan Labeling Approved
Evamist
NDA #022014
Estradiol Spray; Transdermal SUPPL-15 Padagis Us Labeling Approved
Femring
NDA #021367
Estradiol Acetate Insert, Extended Release; Vaginal SUPPL-21 Millicent Labeling Approved
Ganciclovir Sodium
ANDA #207645
Ganciclovir Sodium Injectable; Injection SUPPL-2 Pharmascience Inc Labeling Approved
Glatiramer Acetate
ANDA #091646
Glatiramer Acetate Injectable; Subcutaneous SUPPL-19 Mylan Labeling Approved
Glatiramer Acetate
ANDA #091646
Glatiramer Acetate Injectable; Subcutaneous SUPPL-20 Mylan Labeling Approved
Glatiramer Acetate
ANDA #091646
Glatiramer Acetate Injectable; Subcutaneous SUPPL-19 Mylan Labeling Approved
Glatiramer Acetate
ANDA #091646
Glatiramer Acetate Injectable; Subcutaneous SUPPL-20 Mylan Labeling Approved
Glatiramer Acetate
ANDA #206936
Glatiramer Acetate Injectable; Subcutaneous SUPPL-19 Mylan Labeling Approved
Glatiramer Acetate
ANDA #206936
Glatiramer Acetate Injectable; Subcutaneous SUPPL-20 Mylan Labeling Approved
Glatiramer Acetate
ANDA #206936
Glatiramer Acetate Injectable; Subcutaneous SUPPL-19 Mylan Labeling Approved
Glatiramer Acetate
ANDA #206936
Glatiramer Acetate Injectable; Subcutaneous SUPPL-20 Mylan Labeling Approved
Imvexxy
NDA #208564
Estradiol Insert; Vaginal SUPPL-6 Mayne Pharma Labeling Approved
Isosorbide Mononitrate
ANDA #218255
Isosorbide Mononitrate Tablet, Extended Release; Oral ORIG-1 Zydus Pharms Approved
Lucentis
BLA #125156
Ranibizumab Injectable; Injection SUPPL-128 Genentech Labeling Approved
Menest
ANDA #084948
Estrogens, Esterified Tablet; Oral SUPPL-24 Monarch Pharms Labeling Approved
Menest
ANDA #084949
Estrogens, Esterified Tablet; Oral SUPPL-24 Monarch Pharms Labeling Approved
Menest
ANDA #084950
Estrogens, Esterified Tablet; Oral SUPPL-21 Monarch Pharms Labeling Approved
Menest
ANDA #084951
Estrogens, Esterified Tablet; Oral SUPPL-25 Monarch Pharms Labeling Approved
Menostar
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-49 Bayer Hlthcare Labeling Approved
Menostar
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-50 Bayer Hlthcare Labeling Approved
Minivelle
NDA #203752
Estradiol Film, Extended Release; Transdermal SUPPL-22 Noven Labeling Approved
Minzoya
ANDA #217087
Ethinyl Estradiol; Levonorgestrel Tablet; Oral ORIG-1 Lupin Ltd Approved
Montelukast Sodium
ANDA #207463
Montelukast Sodium Tablet; Oral SUPPL-5 Cipla Labeling Approved
Montelukast Sodium
ANDA #207464
Montelukast Sodium Tablet, Chewable; Oral SUPPL-4 Chartwell Molecular Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #076221
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-15 Barr Labs Inc Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol
ANDA #076221
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral SUPPL-15 Barr Labs Inc Labeling Approved
Ogen .625
ANDA #083220
Estropipate Tablet; Oral SUPPL-45 Pfizer Labeling Approved
Ogen 1.25
ANDA #083220
Estropipate Tablet; Oral SUPPL-45 Pfizer Labeling Approved
Ogen 2.5
ANDA #083220
Estropipate Tablet; Oral SUPPL-45 Pfizer Labeling Approved
Ogen 5
ANDA #083220
Estropipate Tablet; Oral SUPPL-45 Pfizer Labeling Approved
Osphena
NDA #203505
Ospemifene Tablet; Oral SUPPL-22 Duchesnay Labeling Approved
Prefest
NDA #021040
Estradiol; Norgestimate Tablet; Oral SUPPL-15 Teva Womens Labeling Approved
Prefest
NDA #021040
Estradiol; Norgestimate Tablet; Oral SUPPL-15 Teva Womens Labeling Approved
Premarin
NDA #004782
Estrogens, Conjugated Tablet; Oral SUPPL-181 Wyeth Pharms Labeling Approved
Premarin
NDA #010402
Estrogens, Conjugated Injectable; Injection SUPPL-73 Wyeth Pharms Labeling Approved
Premarin
NDA #020216
Estrogens, Conjugated Cream; Topical, Vaginal SUPPL-91 Wyeth Pharms Labeling Approved
Premphase 14/14
NDA #020527
Estrogens, Conjugated; Medroxyprogesterone Acetate Tablet; Oral-28 SUPPL-68 Wyeth Pharms Labeling Approved
Prempro
NDA #020527
Estrogens, Conjugated; Medroxyprogesterone Acetate Tablet; Oral-28 SUPPL-68 Wyeth Pharms Labeling Approved
Prometrium
NDA #019781
Progesterone Capsule; Oral SUPPL-25 Virtus Labeling Approved
Provera
NDA #011839
Medroxyprogesterone Acetate Tablet; Oral SUPPL-83 Pfizer Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-18 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-19 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-21 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-23 Mylan Labs Ltd Labeling Approved
Rifampin
ANDA #065421
Rifampin Injectable; Injection SUPPL-26 Mylan Labs Ltd Labeling Approved
Tepmetko
NDA #214096
Tepotinib Hydrochloride Tablet; Oral SUPPL-3 Emd Serono Inc Efficacy Approved
Vagifem
NDA #020908
Estradiol Tablet; Vaginal SUPPL-30 Novo Nordisk Inc Labeling Approved
Vivelle
NDA #020323
Estradiol System; Transdermal SUPPL-38 Sandoz Labeling Approved
Vivelle-Dot
NDA #020538
Estradiol System; Transdermal SUPPL-43 Sandoz Labeling Approved

February 14, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-16 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-10 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-12 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-16 Mylan Pharms Inc Labeling Approved
Lansoprazole
ANDA #090763
Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-17 Mylan Pharms Inc Labeling Approved
Lisdexamfetamine Dimesylate
ANDA #215802
Lisdexamfetamine Dimesylate Capsule; Oral SUPPL-1 Lannett Co Inc Labeling Approved
Lisdexamfetamine Dimesylate
ANDA #215802
Lisdexamfetamine Dimesylate Capsule; Oral SUPPL-1 Lannett Co Inc Labeling Approved
Oxcarbazepine
ANDA #217782
Oxcarbazepine Suspension; Oral ORIG-1 Medley Pharms Approved
Pantoprazole Sodium
NDA #217512
Pantoprazole Sodium Injectable; Intravenous ORIG-1 Baxter Hlthcare Type 3 - New Dosage Form Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-3 Novel Labs Inc Labeling Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-4 Novel Labs Inc Labeling Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-7 Novel Labs Inc Labeling Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-8 Novel Labs Inc Labeling Approved
Voriconazole
ANDA #206799
Voriconazole For Suspension; Oral SUPPL-9 Novel Labs Inc Labeling Approved

February 13, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atorvastatin Calcium
ANDA #217118
Atorvastatin Calcium Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Aurlumyn
NDA #217933
Iloprost Solution; Injection ORIG-1 Eicos Sciences, Inc. Type 3 - New Dosage Form Approved
Bimatoprost
ANDA #090449
Bimatoprost Solution/Drops; Ophthalmic SUPPL-7 Apotex Labeling Approved
Eletriptan Hydrobromide
ANDA #202040
Eletriptan Hydrobromide Tablet; Oral SUPPL-6 Teva Pharms Usa Labeling Approved
Eletriptan Hydrobromide
ANDA #202040
Eletriptan Hydrobromide Tablet; Oral SUPPL-6 Teva Pharms Usa Labeling Approved
Ibuprofen
ANDA #217236
Ibuprofen Capsule; Oral ORIG-1 Patheon Softgels Approved
Lacosamide
ANDA #217311
Lacosamide Solution; Intravenous ORIG-1 Hainan Poly Approved
Legubeti
NDA #215040
Acetylcysteine Solution; Oral ORIG-1 Galephar Pharmaceutical Research Inc. Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approved
Onivyde
NDA #207793
Irinotecan Hydrochloride Injectable, Liposomal; Intravenous SUPPL-16 Ipsen Efficacy Approved
Ospemifene
ANDA #215574
Ospemifene Tablet; Oral ORIG-1 Hetero Labs Ltd V Approved
Rukobia
NDA #212950
Fostemsavir Tromethamine Tablet, Extended Release; Oral SUPPL-4 Viiv Hlthcare Labeling Approved
Sumatriptan and Naproxen Sodium
ANDA #090872
Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-2 Rising Labeling Approved
Sumatriptan and Naproxen Sodium
ANDA #090872
Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-2 Rising Labeling Approved

February 12, 2024

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Atomoxetine Hydrochloride
ANDA #079019
Atomoxetine Hydrochloride Capsule; Oral SUPPL-2 Glenmark Pharms Ltd Labeling Approved
Atomoxetine Hydrochloride
ANDA #079019
Atomoxetine Hydrochloride Capsule; Oral SUPPL-2 Glenmark Pharms Ltd Labeling Approved
Atomoxetine Hydrochloride
ANDA #079019
Atomoxetine Hydrochloride Capsule; Oral SUPPL-5 Glenmark Pharms Ltd Labeling Approved
Atomoxetine Hydrochloride
ANDA #079019
Atomoxetine Hydrochloride Capsule; Oral SUPPL-5 Glenmark Pharms Ltd Labeling Approved
Bupropion Hydrochloride
ANDA #216766
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Yichang Humanwell Labeling Approved
Bupropion Hydrochloride
ANDA #216766
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Yichang Humanwell Labeling Approved
Bupropion Hydrochloride
ANDA #216766
Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Yichang Humanwell Labeling Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-9 Lgm Pharma Labeling Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-10 Lgm Pharma Labeling Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-7 Lgm Pharma Labeling Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-9 Lgm Pharma Labeling Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-10 Lgm Pharma Labeling Approved
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075231
Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-11 Lgm Pharma Labeling Approved
Diflucan
NDA #019949
Fluconazole Tablet; Oral SUPPL-72 Pfizer Labeling Approved
Diflucan
NDA #020090
Fluconazole For Suspension; Oral SUPPL-53 Pfizer Labeling Approved
Diflucan In Dextrose 5% In Plastic Container
NDA #019950
Fluconazole Injectable; Injection SUPPL-71 Pfizer Labeling Approved
Diflucan In Sodium Chloride 0.9%
NDA #019950
Fluconazole Injectable; Injection SUPPL-71 Pfizer Labeling Approved
Diflucan In Sodium Chloride 0.9% In Plastic Container
NDA #019950
Fluconazole Injectable; Injection SUPPL-71 Pfizer Labeling Approved
Fluoxetine Hydrochloride
ANDA #206993
Fluoxetine Hydrochloride Capsule; Oral SUPPL-4 Cadila Pharms Ltd Labeling Approved
Fluoxetine Hydrochloride
ANDA #206993
Fluoxetine Hydrochloride Capsule; Oral SUPPL-3 Cadila Pharms Ltd Labeling Approved
Fluoxetine Hydrochloride
ANDA #206993
Fluoxetine Hydrochloride Capsule; Oral SUPPL-4 Cadila Pharms Ltd Labeling Approved
Fluvoxamine Maleate
ANDA #091482
Fluvoxamine Maleate Capsule, Extended Release; Oral SUPPL-12 Actavis Elizabeth Labeling Approved
Fluvoxamine Maleate
ANDA #091482
Fluvoxamine Maleate Capsule, Extended Release; Oral SUPPL-12 Actavis Elizabeth Labeling Approved
Levetiracetam In Sodium Chloride
ANDA #211356
Levetiracetam Injectable; Intravenous ORIG-1 Hikma Approved
Linezolid
ANDA #205154
Linezolid Solution; Intravenous SUPPL-13 Mylan Labs Ltd Labeling Approved
Lorazepam
ANDA #091383
Lorazepam Concentrate; Oral SUPPL-5 Amneal Pharms Labeling Approved
Lorazepam
ANDA #091383
Lorazepam Concentrate; Oral SUPPL-9 Amneal Pharms Labeling Approved
Mirabegron
ANDA #215948
Mirabegron Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd Approved
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