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 25, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Thalomid
NDA #020785
Thalidomide Capsule; Oral SUPPL-69 Celgene Labeling Approved

February 24, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ampyra
NDA #022250
Dalfampridine Tablet, Extended Release; Oral SUPPL-18 Acorda Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-8 Gilead Sciences Inc Efficacy Approved
Fludeoxyglucose F18
ANDA #204333
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-5 Ma General Hosp Labeling Approved
Humira
BLA #125057
Adalimumab Syringe SUPPL-417 Abbvie Inc Efficacy Approved
Humira
BLA #125057
Adalimumab Vial SUPPL-417 Abbvie Inc Efficacy Approved
Hyrimoz
BLA #761071
Adalimumab-Adaz Injectable; Injection SUPPL-1 Sandoz Inc Labeling Approved
Naloxegol
ANDA #212625
Naloxegol Unknown ORIG-1 Msn Labs Pvt Ltd Tentative Approval
Nortriptyline Hydrochloride
ANDA #213441
Nortriptyline Hydrochloride Capsule; Oral ORIG-1 Zydus Approved
Succinylcholine Chloride
ANDA #211432
Succinylcholine Chloride Injectable; Injection SUPPL-6 Amneal Labeling Approved

February 23, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetaminophen, Aspirin and Caffeine
ANDA #214039
Acetaminophen; Aspirin; Caffeine Tablet; Oral ORIG-1 Granules Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-2 Mylan Labeling Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-2 Mylan Labeling Approved
Ezetimibe and Simvastatin
ANDA #201890
Ezetimibe; Simvastatin Tablet; Oral SUPPL-10 Ani Pharms Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #201890
Ezetimibe; Simvastatin Tablet; Oral SUPPL-10 Ani Pharms Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #209222
Ezetimibe; Simvastatin Tablet; Oral SUPPL-8 Alkem Labs Ltd Labeling Approved
Fludeoxyglucose F18
ANDA #204385
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-2 Childrens Hosp Mi Labeling Approved
Pemazyre
NDA #213736
Pemigatinib Tablet; Oral SUPPL-1 Incyte Corp Labeling Approved
Pemetrexed
NDA #214218
Pemetrexed Injectable; Injection ORIG-1 Hospira Inc Type 5 - New Formulation or New Manufacturer Tentative Approval
Rufinamide
ANDA #213410
Rufinamide Suspension; Oral ORIG-1 Alkem Labs Ltd Approved

February 22, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #211372
Acetazolamide Tablet; Oral ORIG-1 Appco Approved
Exforge Hct
NDA #022314
Amlodipine Besylate; Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-36 Novartis Labeling Approved
Ibuprofen
ANDA #211666
Ibuprofen Suspension; Oral ORIG-1 Strides Pharma Approved
Libtayo
BLA #761097
Cemiplimab-Rwlc Injectable; Intravenous SUPPL-7 Regeneron Pharmaceuticals Efficacy Approved
Singulair
NDA #020829
Montelukast Sodium Tablet; Oral SUPPL-74 Msd Merck Co Labeling Approved
Singulair
NDA #020830
Montelukast Sodium Tablet, Chewable; Oral SUPPL-76 Msd Merck Co Labeling Approved
Singulair
NDA #021409
Montelukast Sodium Granule; Oral SUPPL-52 Merck Labeling Approved
Spironolactone
ANDA #091426
Spironolactone Tablet; Oral SUPPL-17 Amneal Pharms Labeling Approved
Sumatriptan
ANDA #214209
Sumatriptan Spray; Nasal ORIG-1 Cipla Approved
Veklury
NDA #214787
Remdesivir Powder; Intravenous SUPPL-5 Gilead Sciences Inc Labeling Approved
Veklury
NDA #214787
Remdesivir Solution; Intravenous SUPPL-5 Gilead Sciences Inc Labeling Approved

February 19, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Accuretic
NDA #020125
Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-28 Pfizer Pharms Labeling Approved
Aldactazide
NDA #012616
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-81 Pfizer Labeling Approved
Amitriptyline Hydrochloride
ANDA #213999
Amitriptyline Hydrochloride Tablet; Oral ORIG-1 Mankind Pharma Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Lannett Co Inc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Lannett Co Inc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Lannett Co Inc Labeling Approved
Cefdinir
ANDA #210220
Cefdinir Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Cefdinir
ANDA #210534
Cefdinir For Suspension; Oral ORIG-1 Alkem Labs Ltd Approved
Cefixime
ANDA #211775
Cefixime For Suspension; Oral ORIG-1 Alkem Labs Ltd Approved
Dexmedetomidine Hydrochloride
ANDA #202126
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-5 Sun Pharm Inds Inc Labeling Approved
Famotidine
ANDA #075786
Famotidine Tablet; Oral SUPPL-6 Celltrion Labeling Approved
Halaven
NDA #201532
Eribulin Mesylate Solution; Intravenous SUPPL-20 Eisai Inc Labeling Approved
Halaven
NDA #201532
Eribulin Mesylate Solution; Intravenous SUPPL-20 Eisai Inc Labeling Approved
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-29 Astrazeneca Uk Ltd Efficacy Approved
Lamotrigine
ANDA #203370
Lamotrigine Tablet, Extended Release; Oral SUPPL-12 Torrent Labeling Approved
Lamotrigine
ANDA #203370
Lamotrigine Tablet, Extended Release; Oral SUPPL-12 Torrent Labeling Approved
Linezolid
ANDA #210702
Linezolid Tablet; Oral SUPPL-4 Celltrion Labeling Approved
Methadone Hydrochloride
ANDA #211228
Methadone Hydrochloride Tablet; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved
Methadone Hydrochloride
ANDA #211228
Methadone Hydrochloride Tablet; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved
Mucinex
NDA #021282
Guaifenesin Tablet, Extended Release; Oral SUPPL-54 Rb Hlth Labeling Approved
Mucinex Dm
NDA #021620
Dextromethorphan Hydrobromide; Guaifenesin Tablet, Extended Release; Oral SUPPL-43 Rb Hlth Labeling Approved
Oxymorphone Hydrochloride
ANDA #203601
Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Avanthi Inc Labeling Approved
Oxymorphone Hydrochloride
ANDA #203601
Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Avanthi Inc Labeling Approved
Potassium Citrate
ANDA #214426
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Eywa Approved

February 18, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetaminophen
NDA #204957
Acetaminophen Solution; Intravenous ORIG-1 B Braun Medical Inc Type 5 - New Formulation or New Manufacturer Approved
Azelastine Hydrochloride and Fluticasone Propionate
ANDA #208111
Azelastine Hydrochloride; Fluticasone Propionate Spray, Metered; Nasal ORIG-1 Perrigo Uk Finco Approved
Clindamycin Phosphate In 0.9% Sodium Chloride
NDA #208083
Clindamycin Phosphate Solution; Intravenous SUPPL-4 Baxter Hlthcare Corp Labeling Approved
Clozapine
ANDA #074949
Clozapine Tablet; Oral SUPPL-81 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-46 Mylan REMS Approved
Clozapine
ANDA #075713
Clozapine Tablet; Oral SUPPL-50 Sun Pharm Inds Inc REMS Approved
Clozapine
ANDA #076809
Clozapine Tablet; Oral SUPPL-44 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #090308
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-8 Barr Labs Inc REMS Approved
Clozapine
ANDA #201824
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-13 Mylan REMS Approved
Clozapine
ANDA #202873
Clozapine Tablet; Oral SUPPL-8 Accord Hlthcare REMS Approved
Clozapine
ANDA #203039
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-9 Teva Pharms Usa REMS Approved
Clozapine
ANDA #203807
Clozapine Tablet; Oral SUPPL-10 Mayne Pharma REMS Approved
Clozapine
ANDA #206433
Clozapine Tablet; Oral SUPPL-9 Aurobindo Pharma Ltd REMS Approved
Clozaril
NDA #019758
Clozapine Tablet; Oral SUPPL-96 Heritage Life REMS Approved
Droxidopa
ANDA #211652
Droxidopa Capsule; Oral ORIG-1 Lupin Pharms Approved
Droxidopa
ANDA #211726
Droxidopa Capsule; Oral ORIG-1 Annora Approved
Droxidopa
ANDA #211741
Droxidopa Capsule; Oral ORIG-1 Msn Pharms Inc Approved
Droxidopa
ANDA #211818
Droxidopa Capsule; Oral ORIG-1 Zydus Pharms Approved
Droxidopa
ANDA #212835
Droxidopa Capsule; Oral ORIG-1 Hikma Approved
Droxidopa
ANDA #213162
Droxidopa Capsule; Oral ORIG-1 Teva Pharms Usa Inc Approved
Droxidopa
ANDA #213661
Droxidopa Capsule; Oral ORIG-1 Tasman Pharma Approved
Droxidopa
ANDA #213911
Droxidopa Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Droxidopa
ANDA #214017
Droxidopa Capsule; Oral ORIG-1 Sciegen Pharms Inc Approved
Droxidopa
ANDA #214384
Droxidopa Capsule; Oral ORIG-1 Sun Pharm Approved
Droxidopa
ANDA #214387
Droxidopa Capsule; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Droxidopa
ANDA #214391
Droxidopa Capsule; Oral ORIG-1 Ajanta Pharma Ltd Approved
Ellence
NDA #050778
Epirubicin Hydrochloride Injectable; Injection SUPPL-26 Pfizer Inc Labeling Approved
Famotidine
ANDA #077351
Famotidine Tablet; Oral SUPPL-23 Perrigo R and D Labeling Approved
Famotidine
ANDA #077351
Famotidine Tablet; Oral SUPPL-23 Perrigo R and D Labeling Approved
Methadone Hydrochloride
ANDA #207368
Methadone Hydrochloride Concentrate; Oral SUPPL-2 Specgx Llc Labeling Approved
Methadone Hydrochloride
ANDA #207368
Methadone Hydrochloride Concentrate; Oral SUPPL-2 Specgx Llc Labeling Approved
Methadone Hydrochloride
ANDA #208305
Methadone Hydrochloride Tablet; Oral SUPPL-4 Sun Pharm Industries Labeling Approved
Methadone Hydrochloride
ANDA #208305
Methadone Hydrochloride Tablet; Oral SUPPL-4 Sun Pharm Industries Labeling Approved
Olopatadine Hydrochloride
ANDA #209919
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-2 Alembic Pharms Ltd Labeling Approved
Olopatadine Hydrochloride
ANDA #209919
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-2 Alembic Pharms Ltd Labeling Approved
Piperacillin and Tazobactam
ANDA #065458
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-12 Mylan Labs Ltd Labeling Approved
Piperacillin and Tazobactam
ANDA #203719
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-3 Fresenius Kabi Labeling Approved
Qudexy Xr
NDA #205122
Topiramate Capsule, Extended Release; Oral SUPPL-11 Upsher Smith Labs Labeling Approved
Qudexy Xr
NDA #205122
Topiramate Capsule, Extended Release; Oral SUPPL-11 Upsher Smith Labs Labeling Approved
Versacloz
NDA #203479
Clozapine Suspension; Oral SUPPL-15 Tasman Pharma REMS Approved

February 17, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apremilast
ANDA #211819
Apremilast Tablet; Oral ORIG-1 Unichem Approved
Brilinta
NDA #022433
Ticagrelor Tablet; Oral SUPPL-31 Astrazeneca Labeling Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-28 Viiv Hlthcare Labeling Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-28 Viiv Hlthcare Labeling Approved
Estradiol
ANDA #206388
Estradiol Tablet; Vaginal SUPPL-5 Teva Pharms Usa Labeling Approved
Estradiol
ANDA #206388
Estradiol Tablet; Vaginal SUPPL-5 Teva Pharms Usa Labeling Approved
Estradiol
ANDA #210264
Estradiol Tablet; Vaginal SUPPL-1 Glenmark Pharms Ltd Labeling Approved
Fosphenytoin Sodium
ANDA #078476
Fosphenytoin Sodium Injectable; Injection SUPPL-13 Amneal Labeling Approved
Haloperidol
ANDA #071130
Haloperidol Tablet; Oral SUPPL-11 Cycle Pharms Ltd Manufacturing (CMC) Approved
Haloperidol
ANDA #071130
Haloperidol Tablet; Oral SUPPL-11 Cycle Pharms Ltd Manufacturing (CMC) Approved
Haloperidol
ANDA #071131
Haloperidol Tablet; Oral SUPPL-11 Cycle Pharms Ltd Manufacturing (CMC) Approved
Haloperidol
ANDA #071132
Haloperidol Tablet; Oral SUPPL-10 Cycle Pharms Ltd Manufacturing (CMC) Approved
Levonorgestrel and Ethinyl Estradiol
ANDA #202970
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-1 Mylan Labs Ltd Labeling Approved
Levonorgestrel and Ethinyl Estradiol
ANDA #202970
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-1 Mylan Labs Ltd Labeling Approved
Risedronate Sodium
ANDA #205280
Risedronate Sodium Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Risedronate Sodium
ANDA #205280
Risedronate Sodium Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Sumatriptan
ANDA #208967
Sumatriptan Spray; Nasal ORIG-1 Pharmaserve Nw Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-33 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-34 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-35 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-36 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-37 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-38 Genentech Inc Efficacy Approved
Trizivir
NDA #021205
Abacavir Sulfate; Lamivudine; Zidovudine Tablet; Oral SUPPL-41 Viiv Hlthcare Labeling Approved

February 25, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Thalomid
NDA #020785
Thalidomide Capsule; Oral SUPPL-69 Celgene Labeling Approved

February 24, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ampyra
NDA #022250
Dalfampridine Tablet, Extended Release; Oral SUPPL-18 Acorda Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-8 Gilead Sciences Inc Efficacy Approved
Fludeoxyglucose F18
ANDA #204333
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-5 Ma General Hosp Labeling Approved
Humira
BLA #125057
Adalimumab Syringe SUPPL-417 Abbvie Inc Efficacy Approved
Humira
BLA #125057
Adalimumab Vial SUPPL-417 Abbvie Inc Efficacy Approved
Hyrimoz
BLA #761071
Adalimumab-Adaz Injectable; Injection SUPPL-1 Sandoz Inc Labeling Approved
Naloxegol
ANDA #212625
Naloxegol Unknown ORIG-1 Msn Labs Pvt Ltd Tentative Approval
Nortriptyline Hydrochloride
ANDA #213441
Nortriptyline Hydrochloride Capsule; Oral ORIG-1 Zydus Approved
Succinylcholine Chloride
ANDA #211432
Succinylcholine Chloride Injectable; Injection SUPPL-6 Amneal Labeling Approved

February 23, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetaminophen, Aspirin and Caffeine
ANDA #214039
Acetaminophen; Aspirin; Caffeine Tablet; Oral ORIG-1 Granules Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-2 Mylan Labeling Approved
Everolimus
ANDA #210130
Everolimus Tablet, For Suspension; Oral SUPPL-2 Mylan Labeling Approved
Ezetimibe and Simvastatin
ANDA #201890
Ezetimibe; Simvastatin Tablet; Oral SUPPL-10 Ani Pharms Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #201890
Ezetimibe; Simvastatin Tablet; Oral SUPPL-10 Ani Pharms Inc Labeling Approved
Ezetimibe and Simvastatin
ANDA #209222
Ezetimibe; Simvastatin Tablet; Oral SUPPL-8 Alkem Labs Ltd Labeling Approved
Fludeoxyglucose F18
ANDA #204385
Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-2 Childrens Hosp Mi Labeling Approved
Pemazyre
NDA #213736
Pemigatinib Tablet; Oral SUPPL-1 Incyte Corp Labeling Approved
Pemetrexed
NDA #214218
Pemetrexed Injectable; Injection ORIG-1 Hospira Inc Type 5 - New Formulation or New Manufacturer Tentative Approval
Rufinamide
ANDA #213410
Rufinamide Suspension; Oral ORIG-1 Alkem Labs Ltd Approved

February 22, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #211372
Acetazolamide Tablet; Oral ORIG-1 Appco Approved
Exforge Hct
NDA #022314
Amlodipine Besylate; Hydrochlorothiazide; Valsartan Tablet; Oral SUPPL-36 Novartis Labeling Approved
Ibuprofen
ANDA #211666
Ibuprofen Suspension; Oral ORIG-1 Strides Pharma Approved
Libtayo
BLA #761097
Cemiplimab-Rwlc Injectable; Intravenous SUPPL-7 Regeneron Pharmaceuticals Efficacy Approved
Singulair
NDA #020829
Montelukast Sodium Tablet; Oral SUPPL-74 Msd Merck Co Labeling Approved
Singulair
NDA #020830
Montelukast Sodium Tablet, Chewable; Oral SUPPL-76 Msd Merck Co Labeling Approved
Singulair
NDA #021409
Montelukast Sodium Granule; Oral SUPPL-52 Merck Labeling Approved
Spironolactone
ANDA #091426
Spironolactone Tablet; Oral SUPPL-17 Amneal Pharms Labeling Approved
Sumatriptan
ANDA #214209
Sumatriptan Spray; Nasal ORIG-1 Cipla Approved
Veklury
NDA #214787
Remdesivir Powder; Intravenous SUPPL-5 Gilead Sciences Inc Labeling Approved
Veklury
NDA #214787
Remdesivir Solution; Intravenous SUPPL-5 Gilead Sciences Inc Labeling Approved

February 19, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Accuretic
NDA #020125
Hydrochlorothiazide; Quinapril Hydrochloride Tablet; Oral SUPPL-28 Pfizer Pharms Labeling Approved
Aldactazide
NDA #012616
Hydrochlorothiazide; Spironolactone Tablet; Oral SUPPL-81 Pfizer Labeling Approved
Amitriptyline Hydrochloride
ANDA #213999
Amitriptyline Hydrochloride Tablet; Oral ORIG-1 Mankind Pharma Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Lannett Co Inc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Lannett Co Inc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-9 Lannett Co Inc Labeling Approved
Cefdinir
ANDA #210220
Cefdinir Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Cefdinir
ANDA #210534
Cefdinir For Suspension; Oral ORIG-1 Alkem Labs Ltd Approved
Cefixime
ANDA #211775
Cefixime For Suspension; Oral ORIG-1 Alkem Labs Ltd Approved
Dexmedetomidine Hydrochloride
ANDA #202126
Dexmedetomidine Hydrochloride Injectable; Injection SUPPL-5 Sun Pharm Inds Inc Labeling Approved
Famotidine
ANDA #075786
Famotidine Tablet; Oral SUPPL-6 Celltrion Labeling Approved
Halaven
NDA #201532
Eribulin Mesylate Solution; Intravenous SUPPL-20 Eisai Inc Labeling Approved
Halaven
NDA #201532
Eribulin Mesylate Solution; Intravenous SUPPL-20 Eisai Inc Labeling Approved
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-29 Astrazeneca Uk Ltd Efficacy Approved
Lamotrigine
ANDA #203370
Lamotrigine Tablet, Extended Release; Oral SUPPL-12 Torrent Labeling Approved
Lamotrigine
ANDA #203370
Lamotrigine Tablet, Extended Release; Oral SUPPL-12 Torrent Labeling Approved
Linezolid
ANDA #210702
Linezolid Tablet; Oral SUPPL-4 Celltrion Labeling Approved
Methadone Hydrochloride
ANDA #211228
Methadone Hydrochloride Tablet; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved
Methadone Hydrochloride
ANDA #211228
Methadone Hydrochloride Tablet; Oral SUPPL-1 Ascent Pharms Inc Labeling Approved
Mucinex
NDA #021282
Guaifenesin Tablet, Extended Release; Oral SUPPL-54 Rb Hlth Labeling Approved
Mucinex Dm
NDA #021620
Dextromethorphan Hydrobromide; Guaifenesin Tablet, Extended Release; Oral SUPPL-43 Rb Hlth Labeling Approved
Oxymorphone Hydrochloride
ANDA #203601
Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Avanthi Inc Labeling Approved
Oxymorphone Hydrochloride
ANDA #203601
Oxymorphone Hydrochloride Tablet; Oral SUPPL-3 Avanthi Inc Labeling Approved
Potassium Citrate
ANDA #214426
Potassium Citrate Tablet, Extended Release; Oral ORIG-1 Eywa Approved

February 18, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetaminophen
NDA #204957
Acetaminophen Solution; Intravenous ORIG-1 B Braun Medical Inc Type 5 - New Formulation or New Manufacturer Approved
Azelastine Hydrochloride and Fluticasone Propionate
ANDA #208111
Azelastine Hydrochloride; Fluticasone Propionate Spray, Metered; Nasal ORIG-1 Perrigo Uk Finco Approved
Clindamycin Phosphate In 0.9% Sodium Chloride
NDA #208083
Clindamycin Phosphate Solution; Intravenous SUPPL-4 Baxter Hlthcare Corp Labeling Approved
Clozapine
ANDA #074949
Clozapine Tablet; Oral SUPPL-81 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #075417
Clozapine Tablet; Oral SUPPL-46 Mylan REMS Approved
Clozapine
ANDA #075713
Clozapine Tablet; Oral SUPPL-50 Sun Pharm Inds Inc REMS Approved
Clozapine
ANDA #076809
Clozapine Tablet; Oral SUPPL-44 Ivax Sub Teva Pharms REMS Approved
Clozapine
ANDA #090308
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-8 Barr Labs Inc REMS Approved
Clozapine
ANDA #201824
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-13 Mylan REMS Approved
Clozapine
ANDA #202873
Clozapine Tablet; Oral SUPPL-8 Accord Hlthcare REMS Approved
Clozapine
ANDA #203039
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-9 Teva Pharms Usa REMS Approved
Clozapine
ANDA #203807
Clozapine Tablet; Oral SUPPL-10 Mayne Pharma REMS Approved
Clozapine
ANDA #206433
Clozapine Tablet; Oral SUPPL-9 Aurobindo Pharma Ltd REMS Approved
Clozaril
NDA #019758
Clozapine Tablet; Oral SUPPL-96 Heritage Life REMS Approved
Droxidopa
ANDA #211652
Droxidopa Capsule; Oral ORIG-1 Lupin Pharms Approved
Droxidopa
ANDA #211726
Droxidopa Capsule; Oral ORIG-1 Annora Approved
Droxidopa
ANDA #211741
Droxidopa Capsule; Oral ORIG-1 Msn Pharms Inc Approved
Droxidopa
ANDA #211818
Droxidopa Capsule; Oral ORIG-1 Zydus Pharms Approved
Droxidopa
ANDA #212835
Droxidopa Capsule; Oral ORIG-1 Hikma Approved
Droxidopa
ANDA #213162
Droxidopa Capsule; Oral ORIG-1 Teva Pharms Usa Inc Approved
Droxidopa
ANDA #213661
Droxidopa Capsule; Oral ORIG-1 Tasman Pharma Approved
Droxidopa
ANDA #213911
Droxidopa Capsule; Oral ORIG-1 Alkem Labs Ltd Approved
Droxidopa
ANDA #214017
Droxidopa Capsule; Oral ORIG-1 Sciegen Pharms Inc Approved
Droxidopa
ANDA #214384
Droxidopa Capsule; Oral ORIG-1 Sun Pharm Approved
Droxidopa
ANDA #214387
Droxidopa Capsule; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Droxidopa
ANDA #214391
Droxidopa Capsule; Oral ORIG-1 Ajanta Pharma Ltd Approved
Ellence
NDA #050778
Epirubicin Hydrochloride Injectable; Injection SUPPL-26 Pfizer Inc Labeling Approved
Famotidine
ANDA #077351
Famotidine Tablet; Oral SUPPL-23 Perrigo R and D Labeling Approved
Famotidine
ANDA #077351
Famotidine Tablet; Oral SUPPL-23 Perrigo R and D Labeling Approved
Methadone Hydrochloride
ANDA #207368
Methadone Hydrochloride Concentrate; Oral SUPPL-2 Specgx Llc Labeling Approved
Methadone Hydrochloride
ANDA #207368
Methadone Hydrochloride Concentrate; Oral SUPPL-2 Specgx Llc Labeling Approved
Methadone Hydrochloride
ANDA #208305
Methadone Hydrochloride Tablet; Oral SUPPL-4 Sun Pharm Industries Labeling Approved
Methadone Hydrochloride
ANDA #208305
Methadone Hydrochloride Tablet; Oral SUPPL-4 Sun Pharm Industries Labeling Approved
Olopatadine Hydrochloride
ANDA #209919
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-2 Alembic Pharms Ltd Labeling Approved
Olopatadine Hydrochloride
ANDA #209919
Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-2 Alembic Pharms Ltd Labeling Approved
Piperacillin and Tazobactam
ANDA #065458
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-12 Mylan Labs Ltd Labeling Approved
Piperacillin and Tazobactam
ANDA #203719
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection SUPPL-3 Fresenius Kabi Labeling Approved
Qudexy Xr
NDA #205122
Topiramate Capsule, Extended Release; Oral SUPPL-11 Upsher Smith Labs Labeling Approved
Qudexy Xr
NDA #205122
Topiramate Capsule, Extended Release; Oral SUPPL-11 Upsher Smith Labs Labeling Approved
Versacloz
NDA #203479
Clozapine Suspension; Oral SUPPL-15 Tasman Pharma REMS Approved

February 17, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Apremilast
ANDA #211819
Apremilast Tablet; Oral ORIG-1 Unichem Approved
Brilinta
NDA #022433
Ticagrelor Tablet; Oral SUPPL-31 Astrazeneca Labeling Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-28 Viiv Hlthcare Labeling Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-28 Viiv Hlthcare Labeling Approved
Estradiol
ANDA #206388
Estradiol Tablet; Vaginal SUPPL-5 Teva Pharms Usa Labeling Approved
Estradiol
ANDA #206388
Estradiol Tablet; Vaginal SUPPL-5 Teva Pharms Usa Labeling Approved
Estradiol
ANDA #210264
Estradiol Tablet; Vaginal SUPPL-1 Glenmark Pharms Ltd Labeling Approved
Fosphenytoin Sodium
ANDA #078476
Fosphenytoin Sodium Injectable; Injection SUPPL-13 Amneal Labeling Approved
Haloperidol
ANDA #071130
Haloperidol Tablet; Oral SUPPL-11 Cycle Pharms Ltd Manufacturing (CMC) Approved
Haloperidol
ANDA #071130
Haloperidol Tablet; Oral SUPPL-11 Cycle Pharms Ltd Manufacturing (CMC) Approved
Haloperidol
ANDA #071131
Haloperidol Tablet; Oral SUPPL-11 Cycle Pharms Ltd Manufacturing (CMC) Approved
Haloperidol
ANDA #071132
Haloperidol Tablet; Oral SUPPL-10 Cycle Pharms Ltd Manufacturing (CMC) Approved
Levonorgestrel and Ethinyl Estradiol
ANDA #202970
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-1 Mylan Labs Ltd Labeling Approved
Levonorgestrel and Ethinyl Estradiol
ANDA #202970
Ethinyl Estradiol; Levonorgestrel Tablet; Oral-28 SUPPL-1 Mylan Labs Ltd Labeling Approved
Risedronate Sodium
ANDA #205280
Risedronate Sodium Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Risedronate Sodium
ANDA #205280
Risedronate Sodium Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Sumatriptan
ANDA #208967
Sumatriptan Spray; Nasal ORIG-1 Pharmaserve Nw Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-33 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-34 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-35 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-36 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-37 Genentech Inc Efficacy Approved
Tecentriq
BLA #761034
Atezolizumab Injectable; Injection SUPPL-38 Genentech Inc Efficacy Approved
Trizivir
NDA #021205
Abacavir Sulfate; Lamivudine; Zidovudine Tablet; Oral SUPPL-41 Viiv Hlthcare Labeling Approved

February 16, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Asmanex Twisthaler
NDA #021067
Mometasone Furoate Powder; Inhalation SUPPL-32 Merck Sharp Dohme Labeling Approved
Asmanex Twisthaler
NDA #021067
Mometasone Furoate Powder; Inhalation SUPPL-32 Merck Sharp Dohme Labeling Approved
Buprenorphine Hydrochloride
ANDA #201760
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-15 Sun Pharm Labeling Approved
Buprenorphine Hydrochloride
ANDA #201760
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-15 Sun Pharm Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #207000
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-7 Specgx Llc Labeling Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #207000
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-7 Specgx Llc Labeling Approved
Cerebyx
NDA #020450
Fosphenytoin Sodium Injectable; Injection SUPPL-42 Parke Davis Labeling Approved
Dilantin-125
NDA #008762
Phenytoin Suspension; Oral SUPPL-65 Upjohn Labeling Approved
Dilantin-30
NDA #008762
Phenytoin Suspension; Oral SUPPL-65 Upjohn Labeling Approved
Entresto
NDA #207620
Sacubitril; Valsartan Tablet; Oral SUPPL-18 Novartis Pharms Corp Efficacy Approved
Isoproterenol Hydrochloride
ANDA #210845
Isoproterenol Hydrochloride Injectable; Injection ORIG-1 Micro Labs Approved
Paroxetine Hydrochloride
ANDA #213485
Paroxetine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Cspc Ouyi Approved
Phenytoin Sodium
ANDA #040573
Phenytoin Sodium Injectable; Injection SUPPL-13 Acella Labeling Approved
Phenytoin Sodium
ANDA #040781
Phenytoin Sodium Injectable; Injection SUPPL-7 Am Regent Labeling Approved
Phenytoin Sodium
ANDA #084307
Phenytoin Sodium Injectable; Injection SUPPL-62 West-Ward Pharms Int Labeling Approved
Piperacillin and Tazobactam
ANDA #208674
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection ORIG-1 Sagent Pharms Inc Approved
Piperacillin and Tazobactam
ANDA #208675
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection ORIG-1 Sagent Pharms Inc Approved
Potassium Chloride
ANDA #214686
Potassium Chloride Capsule, Extended Release; Oral ORIG-1 Granules Approved
Pravastatin Sodium
ANDA #076056
Pravastatin Sodium Tablet; Oral SUPPL-21 Teva Labeling Approved
Sotalol Hydrochloride
ANDA #075663
Sotalol Hydrochloride Tablet; Oral SUPPL-3 Impax Pharms Labeling Approved
Sotalol Hydrochloride
ANDA #075725
Sotalol Hydrochloride Tablet; Oral SUPPL-8 Mylan Labeling Approved

February 12, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aminocaproic Acid
ANDA #213928
Aminocaproic Acid Tablet; Oral ORIG-1 Leading Pharma Llc Approved
Cosela
NDA #214200
Trilaciclib Dihydrochloride Injectable; Iv (Infusion) ORIG-1 G1 Therapeutics Inc Type 1 - New Molecular Entity Approved
Daptomycin
NDA #209949
Daptomycin Powder; Iv (Infusion) SUPPL-6 Xellia Pharms Aps Efficacy Tentative Approval
Invega
NDA #021999
Paliperidone Tablet, Extended Release; Oral SUPPL-37 Janssen Pharms Labeling Approved
Invega Sustenna
NDA #022264
Paliperidone Palmitate Suspension, Extended Release; Intramuscular SUPPL-30 Janssen Pharms Labeling Approved
Invega Trinza
NDA #207946
Paliperidone Palmitate Suspension, Extended Release; Intramuscular SUPPL-9 Janssen Pharms Labeling Approved
Jevtana Kit
NDA #201023
Cabazitaxel Solution; Intravenous SUPPL-25 Sanofi Aventis Us Labeling Approved
Jevtana Kit
NDA #201023
Cabazitaxel Solution; Intravenous SUPPL-25 Sanofi Aventis Us Labeling Approved
Lupron Depot
NDA #019943
Leuprolide Acetate Injectable; Injection SUPPL-35 Abbvie Endocrine Inc Labeling Approved
Lupron Depot
NDA #020011
Leuprolide Acetate Injectable; Injection SUPPL-42 Abbvie Endocrine Inc Labeling Approved
Metoprolol Succinate
ANDA #213854
Metoprolol Succinate Tablet, Extended Release; Oral ORIG-1 Yichang Humanwell Approved
Morphine Sulfate
ANDA #211454
Morphine Sulfate Solution; Oral ORIG-1 Winder Labs Llc Approved
Pentolair
ANDA #040075
Cyclopentolate Hydrochloride Solution/Drops; Ophthalmic SUPPL-25 Bausch and Lomb Labeling Approved
Risperdal
NDA #020272
Risperidone Tablet; Oral SUPPL-83 Janssen Pharms Labeling Approved
Risperdal
NDA #020588
Risperidone Solution; Oral SUPPL-71 Janssen Pharms Labeling Approved
Risperdal
NDA #021444
Risperidone Tablet, Orally Disintegrating; Oral SUPPL-57 Janssen Pharms Labeling Approved
Risperdal Consta
NDA #021346
Risperidone Injectable; Intramuscular SUPPL-61 Janssen Pharms Labeling Approved

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