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.

September 16, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Climara
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-45 Bayer Hlthcare Labeling Approved
Climara
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-46 Bayer Hlthcare Labeling Approved
Menostar
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-45 Bayer Hlthcare Labeling Approved
Menostar
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-46 Bayer Hlthcare Labeling Approved
Optison
NDA #020899
Albumin Human Injectable; Injection SUPPL-24 Ge Healthcare Labeling Approved

September 15, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cefuroxime Axetil
ANDA #065359
Cefuroxime Axetil Tablet; Oral SUPPL-10 Orchid Hlthcare Labeling Approved
Dalfampridine
ANDA #210158
Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Micro Labs Labeling Approved
Dalfampridine
ANDA #210158
Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Micro Labs Labeling Approved
Descovy
NDA #208215
Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-19 Gilead Sciences Inc Labeling Approved
Exkivity
NDA #215310
Mobocertinib Capsule; Oral ORIG-1 Takeda Pharms Usa Type 1 - New Molecular Entity Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-9 Novartis Labeling Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet; Oral SUPPL-13 Novartis Labeling Approved
Mycobutin
NDA #050689
Rifabutin Capsule; Oral SUPPL-26 Pfizer Labeling Approved
Oxybutynin Chloride
ANDA #075079
Oxybutynin Chloride Tablet; Oral SUPPL-21 Vintage Pharms Manufacturing (CMC) Approved
Vemlidy
NDA #208464
Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Vimpat
NDA #022253
Lacosamide Tablet; Oral SUPPL-51 Ucb Inc Labeling Approved
Vimpat
NDA #022254
Lacosamide Solution; Intravenous SUPPL-41 Ucb Inc Labeling Approved
Vimpat
NDA #022255
Lacosamide Solution; Oral SUPPL-33 Ucb Inc Labeling Approved

September 14, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Brukinsa
NDA #213217
Zanubrutinib Capsule; Oral SUPPL-5 Beigene Efficacy Approved
Cholestyramine
ANDA #211119
Cholestyramine Powder; Oral SUPPL-6 Ajanta Pharma Ltd Labeling Approved
Hydroxychloroquine Sulfate
ANDA #201691
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-6 Alkaloida Zrt Labeling Approved
Infed
NDA #017441
Ferric Oxyhydroxide Injectable; Injection SUPPL-180 Allergan Labeling Approved
Meclizine Hydrochloride
ANDA #084657
Meclizine Hydrochloride Tablet; Oral SUPPL-54 Ani Pharms Manufacturing (CMC) Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-16 Fresenius Kabi Usa Labeling Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-12 Fresenius Kabi Usa Labeling Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-16 Fresenius Kabi Usa Labeling Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-16 Fresenius Kabi Usa Labeling Approved
Rabeprazole Sodium
ANDA #076822
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Teva Pharms Usa Labeling Approved
Rabeprazole Sodium
ANDA #076822
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Teva Pharms Usa Labeling Approved
Rabeprazole Sodium
ANDA #202376
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Torrent Labeling Approved
Rabeprazole Sodium
ANDA #202376
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Torrent Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Alkem Labs Ltd Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Alkem Labs Ltd Labeling Approved
Rifampin
ANDA #090034
Rifampin Capsule; Oral SUPPL-15 Lupin Pharms Labeling Approved

September 13, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Citalopram Hydrobromide
ANDA #077601
Citalopram Hydrobromide Solution; Oral SUPPL-7 Pharm Assoc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-15 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-14 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-15 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-14 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-15 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077812
Citalopram Hydrobromide Solution; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Citalopram Hydrobromide
ANDA #077812
Citalopram Hydrobromide Solution; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Citalopram Hydrobromide
ANDA #201450
Citalopram Hydrobromide Solution; Oral SUPPL-1 Hetero Labs Ltd Iii Labeling Approved
Citalopram Hydrobromide
ANDA #201450
Citalopram Hydrobromide Solution; Oral SUPPL-1 Hetero Labs Ltd Iii Labeling Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #204287
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Ephedrine Sulfate
ANDA #209646
Ephedrine Sulfate Solution; Intravenous SUPPL-1 Fresenius Kabi Usa Manufacturing (CMC) Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-27 Gilead Sciences Inc Labeling Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-27 Gilead Sciences Inc Labeling Approved
Ibuprofen
ANDA #214699
Ibuprofen Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Methadose
NDA #017116
Methadone Hydrochloride Concentrate; Oral SUPPL-43 Specgx Llc Labeling Approved
Rifampin
ANDA #064150
Rifampin Capsule; Oral SUPPL-35 Sandoz Labeling Approved
Rifampin
ANDA #065390
Rifampin Capsule; Oral SUPPL-19 Lannett Co Inc Labeling Approved

September 12, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fluoxetine Hydrochloride
ANDA #075292
Fluoxetine Hydrochloride Solution; Oral SUPPL-20 Nostrum Labs Inc Labeling Approved
Fluoxetine Hydrochloride
ANDA #075292
Fluoxetine Hydrochloride Solution; Oral SUPPL-20 Nostrum Labs Inc Labeling Approved

September 10, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-15 Bayer Hlthcare Labeling Approved
Avalide
NDA #020758
Hydrochlorothiazide; Irbesartan Tablet; Oral SUPPL-80 Sanofi Aventis Us Labeling Approved
Avapro
NDA #020757
Irbesartan Tablet; Oral SUPPL-74 Sanofi Aventis Us Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Conzip
NDA #022370
Tramadol Hydrochloride Capsule, Extended Release; Oral SUPPL-23 Cipher Pharms Inc Labeling Approved
Epinephrine
NDA #205029
Epinephrine Solution; Intravenous, Intraocular, Intramuscular, Subcutaneous SUPPL-6 Belcher Labeling Approved
Loperamide Hydrochloride and Simethicone
ANDA #213484
Loperamide Hydrochloride; Simethicone Tablet; Oral ORIG-1 Bionpharma Inc Approved
Mayzent
NDA #209884
Siponimod Fumaric Acid Tablet; Oral SUPPL-5 Novartis Labeling Approved
Odefsey
NDA #208351
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Qdolo
NDA #214044
Tramadol Hydrochloride Solution; Oral SUPPL-1 Athena Labeling Approved
Tramadol Hydrochloride
ANDA #078783
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-13 Par Pharm Inc Labeling Approved
Tramadol Hydrochloride
ANDA #091607
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-26 Sun Pharm Labeling Approved
Tramadol Hydrochloride
ANDA #091609
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Actavis Elizabeth Labeling Approved
Tramadol Hydrochloride
ANDA #091609
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Actavis Elizabeth Labeling Approved
Tramadol Hydrochloride
ANDA #200491
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-16 Anchen Pharms Labeling Approved
Tramadol Hydrochloride
ANDA #200503
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Lupin Ltd Labeling Approved
Tramadol Hydrochloride
ANDA #201384
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-23 Sun Pharm Labeling Approved
Tramadol Hydrochloride
ANDA #205257
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Tramadol Hydrochloride
ANDA #205257
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Ultracet
NDA #021123
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-21 Janssen Pharms Labeling Approved
Ultram
NDA #020281
Tramadol Hydrochloride Tablet; Oral SUPPL-49 Janssen Pharms Labeling Approved

September 9, 2021

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Avsola
BLA #761086
Infliximab-Axxq Injectable; Injection SUPPL-1 Amgen Inc Labeling Approved
Avsola
BLA #761086
Infliximab-Axxq Injectable; Injection SUPPL-1 Amgen Inc Labeling Approved
Cyclophosphamide
NDA #212501
Cyclophosphamide Solution; Intravenous SUPPL-2 Ingenus Pharms Llc Labeling Approved
Cyclophosphamide
NDA #212501
Cyclophosphamide Solution; Intravenous SUPPL-2 Ingenus Pharms Llc Labeling Approved
Gabapentin
ANDA #078926
Gabapentin Tablet; Oral SUPPL-18 Zydus Pharms Usa Inc Labeling Approved
Stribild
NDA #203100
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-36 Gilead Sciences Inc Labeling Approved
Stribild
NDA #203100
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-36 Gilead Sciences Inc Labeling Approved
Talzenna
NDA #211651
Talazoparib Tosylate Capsule; Oral SUPPL-7 Pfizer Efficacy Approved
Tybost
NDA #203094
Cobicistat Tablet; Oral SUPPL-16 Gilead Sciences Inc Labeling Approved
Tybost
NDA #203094
Cobicistat Tablet; Oral SUPPL-16 Gilead Sciences Inc Labeling Approved

September 16, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Climara
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-45 Bayer Hlthcare Labeling Approved
Climara
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-46 Bayer Hlthcare Labeling Approved
Menostar
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-45 Bayer Hlthcare Labeling Approved
Menostar
NDA #020375
Estradiol Film, Extended Release; Transdermal SUPPL-46 Bayer Hlthcare Labeling Approved
Optison
NDA #020899
Albumin Human Injectable; Injection SUPPL-24 Ge Healthcare Labeling Approved

September 15, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cefuroxime Axetil
ANDA #065359
Cefuroxime Axetil Tablet; Oral SUPPL-10 Orchid Hlthcare Labeling Approved
Dalfampridine
ANDA #210158
Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Micro Labs Labeling Approved
Dalfampridine
ANDA #210158
Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Micro Labs Labeling Approved
Descovy
NDA #208215
Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-19 Gilead Sciences Inc Labeling Approved
Exkivity
NDA #215310
Mobocertinib Capsule; Oral ORIG-1 Takeda Pharms Usa Type 1 - New Molecular Entity Approved
Kisqali
NDA #209092
Ribociclib Succinate Tablet; Oral SUPPL-9 Novartis Labeling Approved
Kisqali Femara Co-Pack (Copackaged)
NDA #209935
Letrozole; Ribociclib Succinate Tablet; Oral SUPPL-13 Novartis Labeling Approved
Mycobutin
NDA #050689
Rifabutin Capsule; Oral SUPPL-26 Pfizer Labeling Approved
Oxybutynin Chloride
ANDA #075079
Oxybutynin Chloride Tablet; Oral SUPPL-21 Vintage Pharms Manufacturing (CMC) Approved
Vemlidy
NDA #208464
Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Vimpat
NDA #022253
Lacosamide Tablet; Oral SUPPL-51 Ucb Inc Labeling Approved
Vimpat
NDA #022254
Lacosamide Solution; Intravenous SUPPL-41 Ucb Inc Labeling Approved
Vimpat
NDA #022255
Lacosamide Solution; Oral SUPPL-33 Ucb Inc Labeling Approved

September 14, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Brukinsa
NDA #213217
Zanubrutinib Capsule; Oral SUPPL-5 Beigene Efficacy Approved
Cholestyramine
ANDA #211119
Cholestyramine Powder; Oral SUPPL-6 Ajanta Pharma Ltd Labeling Approved
Hydroxychloroquine Sulfate
ANDA #201691
Hydroxychloroquine Sulfate Tablet; Oral SUPPL-6 Alkaloida Zrt Labeling Approved
Infed
NDA #017441
Ferric Oxyhydroxide Injectable; Injection SUPPL-180 Allergan Labeling Approved
Meclizine Hydrochloride
ANDA #084657
Meclizine Hydrochloride Tablet; Oral SUPPL-54 Ani Pharms Manufacturing (CMC) Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-16 Fresenius Kabi Usa Labeling Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-12 Fresenius Kabi Usa Labeling Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-16 Fresenius Kabi Usa Labeling Approved
Methotrexate Preservative Free
ANDA #040266
Methotrexate Sodium Injectable; Injection SUPPL-16 Fresenius Kabi Usa Labeling Approved
Rabeprazole Sodium
ANDA #076822
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Teva Pharms Usa Labeling Approved
Rabeprazole Sodium
ANDA #076822
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-13 Teva Pharms Usa Labeling Approved
Rabeprazole Sodium
ANDA #202376
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Torrent Labeling Approved
Rabeprazole Sodium
ANDA #202376
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-17 Torrent Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Alkem Labs Ltd Labeling Approved
Rabeprazole Sodium
ANDA #208644
Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-10 Alkem Labs Ltd Labeling Approved
Rifampin
ANDA #090034
Rifampin Capsule; Oral SUPPL-15 Lupin Pharms Labeling Approved

September 13, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Citalopram Hydrobromide
ANDA #077601
Citalopram Hydrobromide Solution; Oral SUPPL-7 Pharm Assoc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-15 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-14 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-15 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-14 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077629
Citalopram Hydrobromide Solution; Oral SUPPL-15 Lannett Co Inc Labeling Approved
Citalopram Hydrobromide
ANDA #077812
Citalopram Hydrobromide Solution; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Citalopram Hydrobromide
ANDA #077812
Citalopram Hydrobromide Solution; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Citalopram Hydrobromide
ANDA #201450
Citalopram Hydrobromide Solution; Oral SUPPL-1 Hetero Labs Ltd Iii Labeling Approved
Citalopram Hydrobromide
ANDA #201450
Citalopram Hydrobromide Solution; Oral SUPPL-1 Hetero Labs Ltd Iii Labeling Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #204287
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Macleods Pharms Ltd Approved
Ephedrine Sulfate
ANDA #209646
Ephedrine Sulfate Solution; Intravenous SUPPL-1 Fresenius Kabi Usa Manufacturing (CMC) Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-27 Gilead Sciences Inc Labeling Approved
Genvoya
NDA #207561
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-27 Gilead Sciences Inc Labeling Approved
Ibuprofen
ANDA #214699
Ibuprofen Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Methadose
NDA #017116
Methadone Hydrochloride Concentrate; Oral SUPPL-43 Specgx Llc Labeling Approved
Rifampin
ANDA #064150
Rifampin Capsule; Oral SUPPL-35 Sandoz Labeling Approved
Rifampin
ANDA #065390
Rifampin Capsule; Oral SUPPL-19 Lannett Co Inc Labeling Approved

September 12, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fluoxetine Hydrochloride
ANDA #075292
Fluoxetine Hydrochloride Solution; Oral SUPPL-20 Nostrum Labs Inc Labeling Approved
Fluoxetine Hydrochloride
ANDA #075292
Fluoxetine Hydrochloride Solution; Oral SUPPL-20 Nostrum Labs Inc Labeling Approved

September 10, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-15 Bayer Hlthcare Labeling Approved
Avalide
NDA #020758
Hydrochlorothiazide; Irbesartan Tablet; Oral SUPPL-80 Sanofi Aventis Us Labeling Approved
Avapro
NDA #020757
Irbesartan Tablet; Oral SUPPL-74 Sanofi Aventis Us Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Conzip
NDA #022370
Tramadol Hydrochloride Capsule, Extended Release; Oral SUPPL-23 Cipher Pharms Inc Labeling Approved
Epinephrine
NDA #205029
Epinephrine Solution; Intravenous, Intraocular, Intramuscular, Subcutaneous SUPPL-6 Belcher Labeling Approved
Loperamide Hydrochloride and Simethicone
ANDA #213484
Loperamide Hydrochloride; Simethicone Tablet; Oral ORIG-1 Bionpharma Inc Approved
Mayzent
NDA #209884
Siponimod Fumaric Acid Tablet; Oral SUPPL-5 Novartis Labeling Approved
Odefsey
NDA #208351
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved
Qdolo
NDA #214044
Tramadol Hydrochloride Solution; Oral SUPPL-1 Athena Labeling Approved
Tramadol Hydrochloride
ANDA #078783
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-13 Par Pharm Inc Labeling Approved
Tramadol Hydrochloride
ANDA #091607
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-26 Sun Pharm Labeling Approved
Tramadol Hydrochloride
ANDA #091609
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Actavis Elizabeth Labeling Approved
Tramadol Hydrochloride
ANDA #091609
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-11 Actavis Elizabeth Labeling Approved
Tramadol Hydrochloride
ANDA #200491
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-16 Anchen Pharms Labeling Approved
Tramadol Hydrochloride
ANDA #200503
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-12 Lupin Ltd Labeling Approved
Tramadol Hydrochloride
ANDA #201384
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-23 Sun Pharm Labeling Approved
Tramadol Hydrochloride
ANDA #205257
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Tramadol Hydrochloride
ANDA #205257
Tramadol Hydrochloride Tablet, Extended Release; Oral SUPPL-10 Mylan Labeling Approved
Ultracet
NDA #021123
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-21 Janssen Pharms Labeling Approved
Ultram
NDA #020281
Tramadol Hydrochloride Tablet; Oral SUPPL-49 Janssen Pharms Labeling Approved

September 9, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Avsola
BLA #761086
Infliximab-Axxq Injectable; Injection SUPPL-1 Amgen Inc Labeling Approved
Avsola
BLA #761086
Infliximab-Axxq Injectable; Injection SUPPL-1 Amgen Inc Labeling Approved
Cyclophosphamide
NDA #212501
Cyclophosphamide Solution; Intravenous SUPPL-2 Ingenus Pharms Llc Labeling Approved
Cyclophosphamide
NDA #212501
Cyclophosphamide Solution; Intravenous SUPPL-2 Ingenus Pharms Llc Labeling Approved
Gabapentin
ANDA #078926
Gabapentin Tablet; Oral SUPPL-18 Zydus Pharms Usa Inc Labeling Approved
Stribild
NDA #203100
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-36 Gilead Sciences Inc Labeling Approved
Stribild
NDA #203100
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-36 Gilead Sciences Inc Labeling Approved
Talzenna
NDA #211651
Talazoparib Tosylate Capsule; Oral SUPPL-7 Pfizer Efficacy Approved
Tybost
NDA #203094
Cobicistat Tablet; Oral SUPPL-16 Gilead Sciences Inc Labeling Approved
Tybost
NDA #203094
Cobicistat Tablet; Oral SUPPL-16 Gilead Sciences Inc Labeling Approved

September 8, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Dalfampridine
ANDA #206836
Dalfampridine Tablet, Extended Release; Oral SUPPL-2 Actavis Labs Fl Inc Labeling Approved
Dalfampridine
ANDA #206836
Dalfampridine Tablet, Extended Release; Oral SUPPL-2 Actavis Labs Fl Inc Labeling Approved
Dalfampridine
ANDA #206858
Dalfampridine Tablet, Extended Release; Oral SUPPL-1 Mylan Labeling Approved
Dalfampridine
ANDA #206858
Dalfampridine Tablet, Extended Release; Oral SUPPL-1 Mylan Labeling Approved
Dalfampridine
ANDA #208292
Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Sun Pharm Labeling Approved
Dalfampridine
ANDA #208292
Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Sun Pharm Labeling Approved
Eliglustat Tartrate
ANDA #212463
Eliglustat Tartrate Capsule; Oral ORIG-1 Aizant Approved
Escitalopram Oxalate
ANDA #079121
Escitalopram Oxalate Solution; Oral SUPPL-8 Taro Labeling Approved
Escitalopram Oxalate
ANDA #079121
Escitalopram Oxalate Solution; Oral SUPPL-9 Taro Labeling Approved
Escitalopram Oxalate
ANDA #079121
Escitalopram Oxalate Solution; Oral SUPPL-10 Taro Labeling Approved
Escitalopram Oxalate
ANDA #079121
Escitalopram Oxalate Solution; Oral SUPPL-8 Taro Labeling Approved
Escitalopram Oxalate
ANDA #079121
Escitalopram Oxalate Solution; Oral SUPPL-9 Taro Labeling Approved
Escitalopram Oxalate
ANDA #079121
Escitalopram Oxalate Solution; Oral SUPPL-10 Taro Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-6 Lannett Co Inc Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-4 Lannett Co Inc Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-5 Lannett Co Inc Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-6 Lannett Co Inc Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-4 Lannett Co Inc Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-5 Lannett Co Inc Labeling Approved
Escitalopram Oxalate
ANDA #090477
Escitalopram Oxalate Solution; Oral SUPPL-6 Lannett Co Inc Labeling Approved
Halcinonide
ANDA #214723
Halcinonide Cream; Topical ORIG-1 Glasshouse Pharms Approved
Lactulose
ANDA #207786
Lactulose Solution; Oral SUPPL-2 Torrent Manufacturing (CMC) Approved
Lidocaine Hydrochloride and Epinephrine
ANDA #208475
Epinephrine; Lidocaine Hydrochloride Injectable; Injection ORIG-1 B Braun Medical Inc Approved
Riluzole
ANDA #091300
Riluzole Tablet; Oral SUPPL-1 Apotex Corp Labeling Approved
Riluzole
ANDA #091300
Riluzole Tablet; Oral SUPPL-4 Apotex Corp Labeling Approved
Riluzole
ANDA #203042
Riluzole Tablet; Oral SUPPL-1 Mylan Pharms Inc Labeling Approved
Riluzole
ANDA #203042
Riluzole Tablet; Oral SUPPL-3 Mylan Pharms Inc Labeling Approved

September 7, 2021

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Amphetamine Sulfate
ANDA #213852
Amphetamine Sulfate Tablet; Oral ORIG-1 Rhodes Pharms Approved
Eptifibatide
ANDA #213081
Eptifibatide Injectable; Injection ORIG-1 Shuangcheng Approved
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-6 Janssen Biotech Efficacy Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-15 Aurobindo Pharma Ltd Labeling Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-9 Aurobindo Pharma Ltd Labeling Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-11 Aurobindo Pharma Ltd Labeling Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-9 Aurobindo Pharma Ltd Labeling Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-11 Aurobindo Pharma Ltd Labeling Approved
Escitalopram Oxalate
ANDA #079062
Escitalopram Oxalate Solution; Oral SUPPL-14 Aurobindo Pharma Ltd Labeling Approved
Esomeprazole Magnesium
NDA #214278
Esomeprazole Magnesium Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-1 Dexcel Pharma Labeling Approved
Fluoxetine Hydrochloride
ANDA #077849
Fluoxetine Hydrochloride Solution; Oral SUPPL-11 Lannett Co Inc Labeling Approved
Fluoxetine Hydrochloride
ANDA #077849
Fluoxetine Hydrochloride Solution; Oral SUPPL-12 Lannett Co Inc Labeling Approved
Fluoxetine Hydrochloride
ANDA #077849
Fluoxetine Hydrochloride Solution; Oral SUPPL-11 Lannett Co Inc Labeling Approved
Fluoxetine Hydrochloride
ANDA #077849
Fluoxetine Hydrochloride Solution; Oral SUPPL-12 Lannett Co Inc Labeling Approved
Forteo
NDA #021318
Teriparatide Solution; Subcutaneous SUPPL-56 Lilly Labeling Approved
Forteo
NDA #021318
Teriparatide Solution; Subcutaneous SUPPL-56 Lilly Labeling Approved
Labetalol Hydrochloride
ANDA #214533
Labetalol Hydrochloride Injectable; Injection ORIG-1 Caplin Approved
Nexterone
NDA #022325
Amiodarone Hydrochloride Injectable; Injection SUPPL-16 Baxter Hlthcare Labeling Approved

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