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 24, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aqneursa
NDA #219132 |
Levacetylleucine | Suspension; Oral | ORIG-1 | Intrabio Inc | Type 1 - New Molecular Entity | Approved |
| Felbamate
ANDA #201680 |
Felbamate | Tablet; Oral | SUPPL-14 | Amneal Pharms | Labeling | Approved |
| Felbamate
ANDA #201680 |
Felbamate | Tablet; Oral | SUPPL-14 | Amneal Pharms | Labeling | Approved |
| Felbamate
ANDA #201680 |
Felbamate | Tablet; Oral | SUPPL-14 | Amneal Pharms | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #078433 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-13 | Sun Pharm | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #078759 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-9 | Teyro Labs | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #079160 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-13 | Actavis Totowa | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #091594 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #200145 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-15 | Norvium Bioscience | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #202485 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-18 | Jiangsu Hansoh Pharm | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #204520 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-11 | Gland Pharma Ltd | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #206617 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-3 | Hikma Intl Pharms | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #207575 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-2 | Shilpa | Labeling | Approved |
| Gemcitabine Hydrochloride
NDA #209604 |
Gemcitabine Hydrochloride | Solution; Intravenous | SUPPL-11 | Accord Hlthcare | Labeling | Approved |
| Infugem
NDA #208313 |
Gemcitabine Hydrochloride | Solution; Intravenous | SUPPL-7 | Sun Pharm | Labeling | Approved |
September 23, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Afatinib
ANDA #210770 |
Afatinib | Tablet; Oral | ORIG-1 | Eugia Pharma Speclts | Tentative Approval | |
| Atenolol and Chlorthalidone
ANDA #215560 |
Atenolol; Chlorthalidone | Tablet; Oral | SUPPL-10 | Novitium Pharma | Labeling | Approved |
| Atenolol and Chlorthalidone
ANDA #215560 |
Atenolol; Chlorthalidone | Tablet; Oral | SUPPL-10 | Novitium Pharma | Labeling | Approved |
| Ezetimibe
ANDA #203931 |
Ezetimibe | Tablet; Oral | SUPPL-5 | Sandoz | Labeling | Approved |
| Ezetimibe
ANDA #203931 |
Ezetimibe | Tablet; Oral | SUPPL-5 | Sandoz | Labeling | Approved |
| Ganirelix Acetate
NDA #021057 |
Ganirelix Acetate | Injectable; Injection | SUPPL-24 | Organon Usa Organon | Labeling | Approved |
| Ganirelix Acetate
NDA #021057 |
Ganirelix Acetate | Injectable; Injection | SUPPL-24 | Organon Usa Organon | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-28 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-29 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-20 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-21 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-22 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-24 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-27 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-28 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-28 | Barr | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-1 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-2 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-4 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-5 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-22 | Alembic Pharms Ltd | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-5 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-6 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-8 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-9 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-10 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-7 | Glenmark Speclt | Labeling | Approved |
| Travoprost
ANDA #217228 |
Travoprost | Solution/Drops; Ophthalmic | ORIG-1 | Somerset Theraps Llc | Approved | |
| Truqap
NDA #218197 |
Capivasertib | Tablet; Oral | SUPPL-1 | Astrazeneca | Labeling | Approved |
| Truqap
NDA #218197 |
Capivasertib | Tablet; Oral | SUPPL-1 | Astrazeneca | Labeling | Approved |
September 20, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Actemra
BLA #125276 |
Tocilizumab | Injectable; Injection | SUPPL-144 | Genentech | Efficacy | Approved |
| Actemra
BLA #125472 |
Tocilizumab | Injectable; Intravenous, Subcutaneous | SUPPL-56 | Genentech | Efficacy | Approved |
| Apretude
NDA #215499 |
Cabotegravir | Suspension, Extended Release; Intramuscular | SUPPL-8 | Viiv Hlthcare | Efficacy | Approved |
| Bimzelx
BLA #761151 |
Bimekizumab-Bkzx | Injectable; Injection | SUPPL-5 | Ucb Inc | Efficacy | Approved |
| Bimzelx
BLA #761151 |
Bimekizumab-Bkzx | Injectable; Injection | SUPPL-6 | Ucb Inc | Efficacy | Approved |
| Bimzelx
BLA #761151 |
Bimekizumab-Bkzx | Injectable; Injection | SUPPL-7 | Ucb Inc | Efficacy | Approved |
| Cabenuva Kit
NDA #212888 |
Cabotegravir; Rilpivirine | Suspension, Extended Release; Intramuscular | SUPPL-15 | Viiv Hlthcare | Efficacy | Approved |
| Calcitonin-Salmon
ANDA #213766 |
Calcitonin Salmon | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Cevimeline Hydrochloride
ANDA #206808 |
Cevimeline Hydrochloride | Capsule; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Cipro
NDA #019537 |
Ciprofloxacin Hydrochloride | Tablet; Oral | SUPPL-95 | Bayer Hlthcare | Labeling | Approved |
| Cipro
NDA #019847 |
Ciprofloxacin | Injectable; Injection | SUPPL-64 | Bayer Hlthcare | Labeling | Approved |
| Cipro
NDA #020780 |
Ciprofloxacin | For Suspension; Oral | SUPPL-50 | Bayer Hlthcare | Labeling | Approved |
| Ciprofloxacin
ANDA #076717 |
Ciprofloxacin | Injectable; Injection | SUPPL-8 | Hikma Farmaceutica | Labeling | Approved |
| Ciprofloxacin
ANDA #077782 |
Ciprofloxacin | Injectable; Injection | SUPPL-21 | Dr Reddys | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077701 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077701 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077809 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Ani Pharms | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077809 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Ani Pharms | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078166 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Endo Operations | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078183 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-25 | Rising Pharma | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078712 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-7 | Fosun Pharma | Labeling | Approved |
| Ciprofloxacin In Dextrose 5%
ANDA #076757 |
Ciprofloxacin | Injectable; Injection | SUPPL-10 | Hikma Farmaceutica | Labeling | Approved |
| Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #077753 |
Ciprofloxacin | Injectable; Injection | SUPPL-25 | Hospira | Labeling | Approved |
| Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #078024 |
Ciprofloxacin | Injectable; Injection | SUPPL-40 | Baxter Hlthcare Corp | Labeling | Approved |
| Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #078431 |
Ciprofloxacin | Injectable; Injection | SUPPL-11 | Hikma Farmaceutica | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #215388 |
Clopidogrel Bisulfate | Tablet; Oral | ORIG-1 | Msn | Approved | |
| Diamox
NDA #008943 |
Acetazolamide | Tablet; Oral | SUPPL-53 | Teva Branded Pharm | Labeling | Approved |
| Diamox
NDA #009388 |
Acetazolamide Sodium | Injectable; Injection | SUPPL-39 | Teva Womens | Labeling | Approved |
| Diamox
NDA #012945 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-48 | Teva Branded Pharm | Labeling | Approved |
| Dihydroergotamine Mesylate
ANDA #212334 |
Dihydroergotamine Mesylate | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Ephedrine Sulfate Injection Usp, 50 Mg/10 Ml
ANDA #218211 |
Ephedrine Sulfate | Injectable; Injection | ORIG-1 | Gland Pharma Ltd | Tentative Approval | |
| Fexinidazole
NDA #214429 |
Fexinidazole | Tablet; Oral | SUPPL-3 | Sanofi | Labeling | Approved |
| Fexinidazole
NDA #214429 |
Fexinidazole | Tablet; Oral | SUPPL-4 | Sanofi | Labeling | Approved |
| Gemifloxacin Mesylate
ANDA #090466 |
Gemifloxacin Mesylate | Tablet; Oral | SUPPL-4 | Orbion Pharms | Labeling | Approved |
| Levofloxacin
ANDA #076276 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #076276 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #076361 |
Levofloxacin | Tablet; Oral | SUPPL-17 | Teva | Labeling | Approved |
| Levofloxacin
ANDA #076710 |
Levofloxacin | Tablet; Oral | SUPPL-20 | Dr Reddys Labs Inc | Labeling | Approved |
| Levofloxacin
ANDA #076890 |
Levofloxacin | Tablet; Oral | SUPPL-19 | Chartwell Molecular | Labeling | Approved |
| Levofloxacin
ANDA #077097 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #077097 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #077438 |
Levofloxacin | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Levofloxacin
ANDA #077438 |
Levofloxacin | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Levofloxacin
ANDA #077652 |
Levofloxacin | Tablet; Oral | SUPPL-20 | Zydus Lifesciences | Labeling | Approved |
| Levofloxacin
ANDA #078424 |
Levofloxacin | Tablet; Oral | SUPPL-22 | Lupin | Labeling | Approved |
| Levofloxacin
ANDA #090722 |
Levofloxacin | Tablet; Oral | SUPPL-16 | Torrent Pharms | Labeling | Approved |
| Levofloxacin
ANDA #090787 |
Levofloxacin | Tablet; Oral | SUPPL-14 | Apotex Inc | Labeling | Approved |
| Levofloxacin
ANDA #091436 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Baxter Hlthcare Corp | Labeling | Approved |
| Levofloxacin
ANDA #091644 |
Levofloxacin | Injectable; Injection | SUPPL-19 | Rising Pharma | Labeling | Approved |
| Levofloxacin
ANDA #091678 |
Levofloxacin | Solution; Oral | SUPPL-12 | Novitium Pharma | Labeling | Approved |
| Levofloxacin
ANDA #200250 |
Levofloxacin | Tablet; Oral | SUPPL-7 | Glenmark Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200560 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Norvium Bioscience | Labeling | Approved |
| Levofloxacin
ANDA #200560 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Norvium Bioscience | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-42 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #201043 |
Levofloxacin | Tablet; Oral | SUPPL-34 | Aurobindo Pharma Ltd | Labeling | Approved |
| Levofloxacin
ANDA #201043 |
Levofloxacin | Tablet; Oral | SUPPL-34 | Aurobindo Pharma Ltd | Labeling | Approved |
| Levofloxacin
ANDA #202200 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Orbion Pharms | Labeling | Approved |
| Levofloxacin
ANDA #202328 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Eugia Pharma | Labeling | Approved |
| Levofloxacin
ANDA #202328 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Eugia Pharma | Labeling | Approved |
| Levofloxacin
ANDA #202590 |
Levofloxacin | Injectable; Injection | SUPPL-12 | Avet Lifesciences | Labeling | Approved |
| Levofloxacin
ANDA #202801 |
Levofloxacin | Tablet; Oral | SUPPL-16 | Hetero Labs Ltd V | Labeling | Approved |
| Levofloxacin
ANDA #202801 |
Levofloxacin | Tablet; Oral | SUPPL-16 | Hetero Labs Ltd V | Labeling | Approved |
| Levofloxacin
ANDA #203613 |
Levofloxacin | Tablet; Oral | SUPPL-12 | Jubilant Generics | Labeling | Approved |
| Levofloxacin
ANDA #204968 |
Levofloxacin | Tablet; Oral | SUPPL-2 | Hec Pharm | Labeling | Approved |
| Levofloxacin
ANDA #205222 |
Levofloxacin | Solution; Oral | SUPPL-11 | Lannett Co Inc | Labeling | Approved |
| Levofloxacin
ANDA #205222 |
Levofloxacin | Solution; Oral | SUPPL-11 | Lannett Co Inc | Labeling | Approved |
| Levofloxacin
ANDA #205540 |
Levofloxacin | Injectable; Injection | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Levofloxacin
ANDA #205968 |
Levofloxacin | Injectable; Injection | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Levofloxacin
ANDA #205968 |
Levofloxacin | Injectable; Injection | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #078579 |
Levofloxacin | Injectable; Injection | SUPPL-9 | Hospira | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #091375 |
Levofloxacin | Injectable; Injection | SUPPL-23 | Hikma Farmaceutica | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #091397 |
Levofloxacin | Injectable; Injection | SUPPL-24 | Baxter Hlthcare Corp | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #200674 |
Levofloxacin | Injectable; Injection | SUPPL-13 | Fresenius Kabi Usa | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #206908 |
Levofloxacin | Injectable; Injection | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #206919 |
Levofloxacin | Injectable; Injection | SUPPL-9 | Eugia Pharma | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #206919 |
Levofloxacin | Injectable; Injection | SUPPL-9 | Eugia Pharma | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #216164 |
Levofloxacin | Injectable; Injection | SUPPL-1 | Knack | Labeling | Approved |
| Miplyffa
NDA #214927 |
Arimoclomol Citrate | Capsule; Oral | ORIG-1 | Zevra Denmark As | Type 1 - New Molecular Entity | Approved |
| Sarclisa
BLA #761113 |
Isatuximab-Irfc | Injectable; Injection | SUPPL-14 | Sanofi Aventis Us | Efficacy | Approved |
| Tacrolimus
ANDA #090596 |
Tacrolimus | Capsule; Oral | SUPPL-28 | Mylan | Manufacturing (CMC) | Approved |
| Vocabria
NDA #212887 |
Cabotegravir Sodium | Tablet; Oral | SUPPL-9 | Viiv Hlthcare | Efficacy | Approved |
| Vocabria
NDA #212887 |
Cabotegravir Sodium | Tablet; Oral | SUPPL-10 | Viiv Hlthcare | Efficacy | Approved |
September 19, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Actemra
BLA #125276 |
Tocilizumab | Injectable; Injection | SUPPL-148 | Genentech | Labeling | Approved |
| Actemra
BLA #125472 |
Tocilizumab | Injectable; Intravenous, Subcutaneous | SUPPL-60 | Genentech | Labeling | Approved |
| Bumetanide
ANDA #219116 |
Bumetanide | Injectable; Injection | ORIG-1 | Qilu Pharm Hainan | Approved | |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-18 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-19 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-18 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-19 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-38 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-38 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-43 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-38 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-43 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077289 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-34 | Amneal Pharms Ny | Labeling | Approved |
| Dapagliflozin; Saxagliptin
ANDA #211537 |
Dapagliflozin;Saxagliptin | Tablet; Oral | ORIG-1 | Torrent Pharms Ltd | Tentative Approval | |
| Enalapril Maleate
ANDA #218531 |
Enalapril Maleate | Tablet; Oral | ORIG-1 | Unique Pharm | Approved | |
| Gattex Kit
NDA #203441 |
Teduglutide | Powder; Subcutaneous | SUPPL-22 | Takeda Pharms Usa | Labeling | Approved |
| Gattex Kit
NDA #203441 |
Teduglutide | Powder; Subcutaneous | SUPPL-22 | Takeda Pharms Usa | Labeling | Approved |
| Hydrochlorothiazide
ANDA #083177 |
Hydrochlorothiazide | Tablet; Oral | SUPPL-236 | Ivax Sub Teva Pharms | Manufacturing (CMC) | Approved |
| Hydrochlorothiazide
ANDA #083177 |
Hydrochlorothiazide | Tablet; Oral | SUPPL-236 | Ivax Sub Teva Pharms | Manufacturing (CMC) | Approved |
| Kineret
BLA #103950 |
Anakinra | Vial; Subcutaneous | SUPPL-5198 | Biovitrum Ab | Labeling | Approved |
| Kineret
BLA #103950 |
Anakinra | Vial; Subcutaneous | SUPPL-5198 | Biovitrum Ab | Labeling | Approved |
| Lamivudine and Zidovudine
ANDA #079124 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-10 | Hetero Labs Ltd Iii | Labeling | Approved |
| Lamivudine and Zidovudine
ANDA #079124 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-14 | Hetero Labs Ltd Iii | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-29 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-33 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-34 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-29 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-33 | Perrigo R and D | Labeling | Approved |
| Nalbuphine Hydrochloride
ANDA #216049 |
Nalbuphine Hydrochloride | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Nalbuphine Hydrochloride
ANDA #216050 |
Nalbuphine Hydrochloride | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Oxycodone and Acetaminophen
ANDA #201448 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-5 | Nostrum Labs Inc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #201448 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-5 | Nostrum Labs Inc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #203864 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-10 | Epic Pharma Llc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #207574 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Cerovene Inc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #207574 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Cerovene Inc | Labeling | Approved |
| Pylera
NDA #050786 |
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride | Capsule; Oral | SUPPL-27 | Labs Juvise | Labeling | Approved |
| Rybrevant
BLA #761210 |
Amivantamab-Vmjw | Injectable; Injection | SUPPL-4 | Janssen Biotech | Efficacy | Approved |
| Soliris
BLA #125166 |
Eculizumab | Injectable; Iv (Infusion) | SUPPL-447 | Alexion Pharm | Labeling | Approved |
| Ultomiris
BLA #761108 |
Ravulizumab-Cwvz | Injectable; Injection | SUPPL-37 | Alexion Pharm | Labeling | Approved |
September 18, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amoxicillin
ANDA #065256 |
Amoxicillin | Tablet; Oral | SUPPL-27 | Aurobindo | Manufacturing (CMC) | Approved |
| Atenolol
ANDA #073457 |
Atenolol | Tablet; Oral | SUPPL-47 | Mylan | Labeling | Approved |
| Atenolol
ANDA #073457 |
Atenolol | Tablet; Oral | SUPPL-47 | Mylan | Labeling | Approved |
| Bumetanide
ANDA #212931 |
Bumetanide | Tablet; Oral | ORIG-1 | Appco | Approved | |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-11 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-12 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-11 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-12 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077141 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-3 | Natco Pharma Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077534 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-25 | Invagen Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077534 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-25 | Invagen Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-40 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-39 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-40 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-39 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-40 | Torrent Pharms | Labeling | Approved |
| Rhopressa
NDA #208254 |
Netarsudil Mesylate | Solution/Drops; Ophthalmic | SUPPL-14 | Alcon Labs Inc | Labeling | Approved |
September 17, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bosentan
ANDA #205699 |
Bosentan | Tablet; Oral | SUPPL-4 | Endo Operations | REMS | Approved |
| Bosentan
ANDA #206987 |
Bosentan | Tablet; Oral | SUPPL-5 | Natco Pharma Ltd | REMS | Approved |
| Bosentan
ANDA #207110 |
Bosentan | Tablet; Oral | SUPPL-8 | Watson Labs Inc | REMS | Approved |
| Bosentan
ANDA #207760 |
Bosentan | Tablet; Oral | SUPPL-10 | Zydus Pharms | REMS | Approved |
| Bosentan
ANDA #209324 |
Bosentan | Tablet; Oral | SUPPL-10 | Sun Pharm | REMS | Approved |
| Bosentan
ANDA #209742 |
Bosentan | Tablet; Oral | SUPPL-9 | Amneal Pharms Co | REMS | Approved |
| Bumetanide
ANDA #217153 |
Bumetanide | Injectable; Injection | ORIG-1 | Lupin Ltd | Approved | |
| Dexamethasone
ANDA #218372 |
Dexamethasone | Tablet; Oral | ORIG-1 | Corepharma | Approved | |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-9 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-11 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-9 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-9 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-11 | Prinston Inc | Labeling | Approved |
| Ertugliflozin
ANDA #217071 |
Ertugliflozin | Tablet; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
| Evrysdi
NDA #213535 |
Risdiplam | For Solution; Oral | SUPPL-13 | Genentech Inc | Efficacy | Approved |
| Fasenra
BLA #761070 |
Benralizumab | Injectable; Injection | SUPPL-21 | Astrazeneca Ab | Efficacy | Approved |
| Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-161 | Merck Sharp Dohme | Efficacy | Approved |
| Kisqali
NDA #209092 |
Ribociclib Succinate | Tablet; Oral | SUPPL-18 | Novartis | Efficacy | Approved |
| Kisqali Femara Co-Pack (Copackaged)
NDA #209935 |
Letrozole; Ribociclib Succinate | Tablet; Oral | SUPPL-27 | Novartis | Efficacy | Approved |
| Lactulose
ANDA #075911 |
Lactulose | Solution; Oral | SUPPL-12 | Xttrium Labs Inc | Manufacturing (CMC) | Approved |
| Metyrosine
ANDA #215541 |
Metyrosine | Capsule; Oral | ORIG-1 | Leading | Approved | |
| Prazosin Hydrochloride
ANDA #216727 |
Prazosin Hydrochloride | Capsule; Oral | ORIG-1 | Msn | Approved | |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-45 | Actelion | REMS | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-11 | Actelion | REMS | Approved |
September 16, 2024
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-42 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-45 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-42 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-45 | Watson Labs Inc | Labeling | Approved |
| Chemet
NDA #019998 |
Succimer | Capsule; Oral | SUPPL-23 | Recordati Rare | Labeling | Approved |
| Clobazam
ANDA #210039 |
Clobazam | Suspension; Oral | SUPPL-9 | Amneal | Labeling | Approved |
| Clobazam
ANDA #210039 |
Clobazam | Suspension; Oral | SUPPL-9 | Amneal | Labeling | Approved |
| Clobazam
ANDA #216008 |
Clobazam | Suspension; Oral | SUPPL-2 | Accord Hlthcare | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-4 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-4 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #212143 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-2 | Chia Tai Tianqing | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #212143 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-2 | Chia Tai Tianqing | Labeling | Approved |
| Iyuzeh
NDA #216472 |
Latanoprost | Solution/Drops; Ophthalmic | SUPPL-2 | Thea Pharma | Labeling | Approved |
| Ketoconazole
ANDA #218498 |
Ketoconazole | Shampoo; Topical | ORIG-1 | Novitium Pharma | Approved | |
| Lanreotide Acetate
NDA #215395 |
Lanreotide Acetate | Solution; Subcutaneous | SUPPL-7 | Invagen Pharms | Efficacy | Approved |
| Lansoprazole
ANDA #200816 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Lansoprazole
ANDA #200816 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Lansoprazole
ANDA #200816 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-11 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-11 | Amneal Pharms | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-31 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-31 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-31 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-33 | Macleods Pharms Ltd | Labeling | Approved |
| Levothyroxine Sodium
ANDA #212399 |
Levothyroxine Sodium | Tablet; Oral | SUPPL-6 | Accord Hlthcare | Labeling | Approved |
| Levothyroxine Sodium
ANDA #212399 |
Levothyroxine Sodium | Tablet; Oral | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202802 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Actavis Elizabeth | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202802 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Actavis Elizabeth | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202802 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Actavis Elizabeth | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202830 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Amneal | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202830 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Amneal | Labeling | Approved |
| Medroxyprogesterone Acetate
ANDA #040159 |
Medroxyprogesterone Acetate | Tablet; Oral | SUPPL-34 | Barr | Labeling | Approved |
| Medroxyprogesterone Acetate
ANDA #040159 |
Medroxyprogesterone Acetate | Tablet; Oral | SUPPL-34 | Barr | Labeling | Approved |
| Sacubitril and Valsartan
ANDA #213764 |
Sacubitril; Valsartan | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Sancuso
NDA #022198 |
Granisetron | Film, Extended Release; Transdermal | SUPPL-23 | Cumberland | Labeling | Approved |
| Sirolimus
ANDA #215080 |
Sirolimus | Solution; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
| Timolol Maleate
ANDA #210640 |
Timolol Maleate | Solution, Gel Forming/Drops; Ophthalmic | ORIG-1 | Somerset Theraps Llc | Approved | |
| Zyclara
NDA #022483 |
Imiquimod | Cream; Topical | SUPPL-11 | Bausch | Labeling | Approved |
| Zyclara
NDA #022483 |
Imiquimod | Cream; Topical | SUPPL-11 | Bausch | Labeling | Approved |
September 24, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aqneursa
NDA #219132 |
Levacetylleucine | Suspension; Oral | ORIG-1 | Intrabio Inc | Type 1 - New Molecular Entity | Approved |
| Felbamate
ANDA #201680 |
Felbamate | Tablet; Oral | SUPPL-14 | Amneal Pharms | Labeling | Approved |
| Felbamate
ANDA #201680 |
Felbamate | Tablet; Oral | SUPPL-14 | Amneal Pharms | Labeling | Approved |
| Felbamate
ANDA #201680 |
Felbamate | Tablet; Oral | SUPPL-14 | Amneal Pharms | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #078433 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-13 | Sun Pharm | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #078759 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-9 | Teyro Labs | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #079160 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-13 | Actavis Totowa | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #091594 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #200145 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-15 | Norvium Bioscience | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #202485 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-18 | Jiangsu Hansoh Pharm | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #204520 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-11 | Gland Pharma Ltd | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #206617 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-3 | Hikma Intl Pharms | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #207575 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-2 | Shilpa | Labeling | Approved |
| Gemcitabine Hydrochloride
NDA #209604 |
Gemcitabine Hydrochloride | Solution; Intravenous | SUPPL-11 | Accord Hlthcare | Labeling | Approved |
| Infugem
NDA #208313 |
Gemcitabine Hydrochloride | Solution; Intravenous | SUPPL-7 | Sun Pharm | Labeling | Approved |
September 23, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Afatinib
ANDA #210770 |
Afatinib | Tablet; Oral | ORIG-1 | Eugia Pharma Speclts | Tentative Approval | |
| Atenolol and Chlorthalidone
ANDA #215560 |
Atenolol; Chlorthalidone | Tablet; Oral | SUPPL-10 | Novitium Pharma | Labeling | Approved |
| Atenolol and Chlorthalidone
ANDA #215560 |
Atenolol; Chlorthalidone | Tablet; Oral | SUPPL-10 | Novitium Pharma | Labeling | Approved |
| Ezetimibe
ANDA #203931 |
Ezetimibe | Tablet; Oral | SUPPL-5 | Sandoz | Labeling | Approved |
| Ezetimibe
ANDA #203931 |
Ezetimibe | Tablet; Oral | SUPPL-5 | Sandoz | Labeling | Approved |
| Ganirelix Acetate
NDA #021057 |
Ganirelix Acetate | Injectable; Injection | SUPPL-24 | Organon Usa Organon | Labeling | Approved |
| Ganirelix Acetate
NDA #021057 |
Ganirelix Acetate | Injectable; Injection | SUPPL-24 | Organon Usa Organon | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-28 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-29 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-20 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-21 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-22 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-24 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-27 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-28 | Barr | Labeling | Approved |
| Hydroxyurea
ANDA #075143 |
Hydroxyurea | Capsule; Oral | SUPPL-28 | Barr | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-1 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-2 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-4 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-5 | Alembic Pharms Ltd | Labeling | Approved |
| Leflunomide
ANDA #091369 |
Leflunomide | Tablet; Oral | SUPPL-22 | Alembic Pharms Ltd | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-5 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-6 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-8 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-9 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-10 | Glenmark Speclt | Labeling | Approved |
| Linezolid
ANDA #078987 |
Linezolid | Tablet; Oral | SUPPL-7 | Glenmark Speclt | Labeling | Approved |
| Travoprost
ANDA #217228 |
Travoprost | Solution/Drops; Ophthalmic | ORIG-1 | Somerset Theraps Llc | Approved | |
| Truqap
NDA #218197 |
Capivasertib | Tablet; Oral | SUPPL-1 | Astrazeneca | Labeling | Approved |
| Truqap
NDA #218197 |
Capivasertib | Tablet; Oral | SUPPL-1 | Astrazeneca | Labeling | Approved |
September 20, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Actemra
BLA #125276 |
Tocilizumab | Injectable; Injection | SUPPL-144 | Genentech | Efficacy | Approved |
| Actemra
BLA #125472 |
Tocilizumab | Injectable; Intravenous, Subcutaneous | SUPPL-56 | Genentech | Efficacy | Approved |
| Apretude
NDA #215499 |
Cabotegravir | Suspension, Extended Release; Intramuscular | SUPPL-8 | Viiv Hlthcare | Efficacy | Approved |
| Bimzelx
BLA #761151 |
Bimekizumab-Bkzx | Injectable; Injection | SUPPL-5 | Ucb Inc | Efficacy | Approved |
| Bimzelx
BLA #761151 |
Bimekizumab-Bkzx | Injectable; Injection | SUPPL-6 | Ucb Inc | Efficacy | Approved |
| Bimzelx
BLA #761151 |
Bimekizumab-Bkzx | Injectable; Injection | SUPPL-7 | Ucb Inc | Efficacy | Approved |
| Cabenuva Kit
NDA #212888 |
Cabotegravir; Rilpivirine | Suspension, Extended Release; Intramuscular | SUPPL-15 | Viiv Hlthcare | Efficacy | Approved |
| Calcitonin-Salmon
ANDA #213766 |
Calcitonin Salmon | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Cevimeline Hydrochloride
ANDA #206808 |
Cevimeline Hydrochloride | Capsule; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Cipro
NDA #019537 |
Ciprofloxacin Hydrochloride | Tablet; Oral | SUPPL-95 | Bayer Hlthcare | Labeling | Approved |
| Cipro
NDA #019847 |
Ciprofloxacin | Injectable; Injection | SUPPL-64 | Bayer Hlthcare | Labeling | Approved |
| Cipro
NDA #020780 |
Ciprofloxacin | For Suspension; Oral | SUPPL-50 | Bayer Hlthcare | Labeling | Approved |
| Ciprofloxacin
ANDA #076717 |
Ciprofloxacin | Injectable; Injection | SUPPL-8 | Hikma Farmaceutica | Labeling | Approved |
| Ciprofloxacin
ANDA #077782 |
Ciprofloxacin | Injectable; Injection | SUPPL-21 | Dr Reddys | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077701 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077701 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077809 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Ani Pharms | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077809 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-10 | Ani Pharms | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078166 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-17 | Endo Operations | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078183 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-25 | Rising Pharma | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078712 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-7 | Fosun Pharma | Labeling | Approved |
| Ciprofloxacin In Dextrose 5%
ANDA #076757 |
Ciprofloxacin | Injectable; Injection | SUPPL-10 | Hikma Farmaceutica | Labeling | Approved |
| Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #077753 |
Ciprofloxacin | Injectable; Injection | SUPPL-25 | Hospira | Labeling | Approved |
| Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #078024 |
Ciprofloxacin | Injectable; Injection | SUPPL-40 | Baxter Hlthcare Corp | Labeling | Approved |
| Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #078431 |
Ciprofloxacin | Injectable; Injection | SUPPL-11 | Hikma Farmaceutica | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #215388 |
Clopidogrel Bisulfate | Tablet; Oral | ORIG-1 | Msn | Approved | |
| Diamox
NDA #008943 |
Acetazolamide | Tablet; Oral | SUPPL-53 | Teva Branded Pharm | Labeling | Approved |
| Diamox
NDA #009388 |
Acetazolamide Sodium | Injectable; Injection | SUPPL-39 | Teva Womens | Labeling | Approved |
| Diamox
NDA #012945 |
Acetazolamide | Capsule, Extended Release; Oral | SUPPL-48 | Teva Branded Pharm | Labeling | Approved |
| Dihydroergotamine Mesylate
ANDA #212334 |
Dihydroergotamine Mesylate | Injectable; Injection | ORIG-1 | Cipla | Approved | |
| Ephedrine Sulfate Injection Usp, 50 Mg/10 Ml
ANDA #218211 |
Ephedrine Sulfate | Injectable; Injection | ORIG-1 | Gland Pharma Ltd | Tentative Approval | |
| Fexinidazole
NDA #214429 |
Fexinidazole | Tablet; Oral | SUPPL-3 | Sanofi | Labeling | Approved |
| Fexinidazole
NDA #214429 |
Fexinidazole | Tablet; Oral | SUPPL-4 | Sanofi | Labeling | Approved |
| Gemifloxacin Mesylate
ANDA #090466 |
Gemifloxacin Mesylate | Tablet; Oral | SUPPL-4 | Orbion Pharms | Labeling | Approved |
| Levofloxacin
ANDA #076276 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #076276 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #076361 |
Levofloxacin | Tablet; Oral | SUPPL-17 | Teva | Labeling | Approved |
| Levofloxacin
ANDA #076710 |
Levofloxacin | Tablet; Oral | SUPPL-20 | Dr Reddys Labs Inc | Labeling | Approved |
| Levofloxacin
ANDA #076890 |
Levofloxacin | Tablet; Oral | SUPPL-19 | Chartwell Molecular | Labeling | Approved |
| Levofloxacin
ANDA #077097 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #077097 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Natco Pharma | Labeling | Approved |
| Levofloxacin
ANDA #077438 |
Levofloxacin | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Levofloxacin
ANDA #077438 |
Levofloxacin | Tablet; Oral | SUPPL-22 | Sandoz | Labeling | Approved |
| Levofloxacin
ANDA #077652 |
Levofloxacin | Tablet; Oral | SUPPL-20 | Zydus Lifesciences | Labeling | Approved |
| Levofloxacin
ANDA #078424 |
Levofloxacin | Tablet; Oral | SUPPL-22 | Lupin | Labeling | Approved |
| Levofloxacin
ANDA #090722 |
Levofloxacin | Tablet; Oral | SUPPL-16 | Torrent Pharms | Labeling | Approved |
| Levofloxacin
ANDA #090787 |
Levofloxacin | Tablet; Oral | SUPPL-14 | Apotex Inc | Labeling | Approved |
| Levofloxacin
ANDA #091436 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Baxter Hlthcare Corp | Labeling | Approved |
| Levofloxacin
ANDA #091644 |
Levofloxacin | Injectable; Injection | SUPPL-19 | Rising Pharma | Labeling | Approved |
| Levofloxacin
ANDA #091678 |
Levofloxacin | Solution; Oral | SUPPL-12 | Novitium Pharma | Labeling | Approved |
| Levofloxacin
ANDA #200250 |
Levofloxacin | Tablet; Oral | SUPPL-7 | Glenmark Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200560 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Norvium Bioscience | Labeling | Approved |
| Levofloxacin
ANDA #200560 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Norvium Bioscience | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-42 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #201043 |
Levofloxacin | Tablet; Oral | SUPPL-34 | Aurobindo Pharma Ltd | Labeling | Approved |
| Levofloxacin
ANDA #201043 |
Levofloxacin | Tablet; Oral | SUPPL-34 | Aurobindo Pharma Ltd | Labeling | Approved |
| Levofloxacin
ANDA #202200 |
Levofloxacin | Tablet; Oral | SUPPL-11 | Orbion Pharms | Labeling | Approved |
| Levofloxacin
ANDA #202328 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Eugia Pharma | Labeling | Approved |
| Levofloxacin
ANDA #202328 |
Levofloxacin | Injectable; Injection | SUPPL-14 | Eugia Pharma | Labeling | Approved |
| Levofloxacin
ANDA #202590 |
Levofloxacin | Injectable; Injection | SUPPL-12 | Avet Lifesciences | Labeling | Approved |
| Levofloxacin
ANDA #202801 |
Levofloxacin | Tablet; Oral | SUPPL-16 | Hetero Labs Ltd V | Labeling | Approved |
| Levofloxacin
ANDA #202801 |
Levofloxacin | Tablet; Oral | SUPPL-16 | Hetero Labs Ltd V | Labeling | Approved |
| Levofloxacin
ANDA #203613 |
Levofloxacin | Tablet; Oral | SUPPL-12 | Jubilant Generics | Labeling | Approved |
| Levofloxacin
ANDA #204968 |
Levofloxacin | Tablet; Oral | SUPPL-2 | Hec Pharm | Labeling | Approved |
| Levofloxacin
ANDA #205222 |
Levofloxacin | Solution; Oral | SUPPL-11 | Lannett Co Inc | Labeling | Approved |
| Levofloxacin
ANDA #205222 |
Levofloxacin | Solution; Oral | SUPPL-11 | Lannett Co Inc | Labeling | Approved |
| Levofloxacin
ANDA #205540 |
Levofloxacin | Injectable; Injection | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Levofloxacin
ANDA #205968 |
Levofloxacin | Injectable; Injection | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Levofloxacin
ANDA #205968 |
Levofloxacin | Injectable; Injection | SUPPL-5 | Zydus Pharms | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #078579 |
Levofloxacin | Injectable; Injection | SUPPL-9 | Hospira | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #091375 |
Levofloxacin | Injectable; Injection | SUPPL-23 | Hikma Farmaceutica | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #091397 |
Levofloxacin | Injectable; Injection | SUPPL-24 | Baxter Hlthcare Corp | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #200674 |
Levofloxacin | Injectable; Injection | SUPPL-13 | Fresenius Kabi Usa | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #206908 |
Levofloxacin | Injectable; Injection | SUPPL-1 | Gland Pharma Ltd | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #206919 |
Levofloxacin | Injectable; Injection | SUPPL-9 | Eugia Pharma | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #206919 |
Levofloxacin | Injectable; Injection | SUPPL-9 | Eugia Pharma | Labeling | Approved |
| Levofloxacin In Dextrose 5% In Plastic Container
ANDA #216164 |
Levofloxacin | Injectable; Injection | SUPPL-1 | Knack | Labeling | Approved |
| Miplyffa
NDA #214927 |
Arimoclomol Citrate | Capsule; Oral | ORIG-1 | Zevra Denmark As | Type 1 - New Molecular Entity | Approved |
| Sarclisa
BLA #761113 |
Isatuximab-Irfc | Injectable; Injection | SUPPL-14 | Sanofi Aventis Us | Efficacy | Approved |
| Tacrolimus
ANDA #090596 |
Tacrolimus | Capsule; Oral | SUPPL-28 | Mylan | Manufacturing (CMC) | Approved |
| Vocabria
NDA #212887 |
Cabotegravir Sodium | Tablet; Oral | SUPPL-9 | Viiv Hlthcare | Efficacy | Approved |
| Vocabria
NDA #212887 |
Cabotegravir Sodium | Tablet; Oral | SUPPL-10 | Viiv Hlthcare | Efficacy | Approved |
September 19, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Actemra
BLA #125276 |
Tocilizumab | Injectable; Injection | SUPPL-148 | Genentech | Labeling | Approved |
| Actemra
BLA #125472 |
Tocilizumab | Injectable; Intravenous, Subcutaneous | SUPPL-60 | Genentech | Labeling | Approved |
| Bumetanide
ANDA #219116 |
Bumetanide | Injectable; Injection | ORIG-1 | Qilu Pharm Hainan | Approved | |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-18 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-19 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-16 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-17 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-18 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077038 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-19 | Dr Reddys Labs Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-38 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-38 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-43 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-38 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077042 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-43 | Mylan | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077289 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-34 | Amneal Pharms Ny | Labeling | Approved |
| Dapagliflozin; Saxagliptin
ANDA #211537 |
Dapagliflozin;Saxagliptin | Tablet; Oral | ORIG-1 | Torrent Pharms Ltd | Tentative Approval | |
| Enalapril Maleate
ANDA #218531 |
Enalapril Maleate | Tablet; Oral | ORIG-1 | Unique Pharm | Approved | |
| Gattex Kit
NDA #203441 |
Teduglutide | Powder; Subcutaneous | SUPPL-22 | Takeda Pharms Usa | Labeling | Approved |
| Gattex Kit
NDA #203441 |
Teduglutide | Powder; Subcutaneous | SUPPL-22 | Takeda Pharms Usa | Labeling | Approved |
| Hydrochlorothiazide
ANDA #083177 |
Hydrochlorothiazide | Tablet; Oral | SUPPL-236 | Ivax Sub Teva Pharms | Manufacturing (CMC) | Approved |
| Hydrochlorothiazide
ANDA #083177 |
Hydrochlorothiazide | Tablet; Oral | SUPPL-236 | Ivax Sub Teva Pharms | Manufacturing (CMC) | Approved |
| Kineret
BLA #103950 |
Anakinra | Vial; Subcutaneous | SUPPL-5198 | Biovitrum Ab | Labeling | Approved |
| Kineret
BLA #103950 |
Anakinra | Vial; Subcutaneous | SUPPL-5198 | Biovitrum Ab | Labeling | Approved |
| Lamivudine and Zidovudine
ANDA #079124 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-10 | Hetero Labs Ltd Iii | Labeling | Approved |
| Lamivudine and Zidovudine
ANDA #079124 |
Lamivudine; Zidovudine | Tablet; Oral | SUPPL-14 | Hetero Labs Ltd Iii | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-29 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-33 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-34 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-29 | Perrigo R and D | Labeling | Approved |
| Lansoprazole
ANDA #202319 |
Lansoprazole | Capsule, Delayed Rel Pellets; Oral | SUPPL-33 | Perrigo R and D | Labeling | Approved |
| Nalbuphine Hydrochloride
ANDA #216049 |
Nalbuphine Hydrochloride | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Nalbuphine Hydrochloride
ANDA #216050 |
Nalbuphine Hydrochloride | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Oxycodone and Acetaminophen
ANDA #201448 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-5 | Nostrum Labs Inc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #201448 |
Acetaminophen; Oxycodone Hydrochloride | Solution; Oral | SUPPL-5 | Nostrum Labs Inc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #203864 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-10 | Epic Pharma Llc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #207574 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Cerovene Inc | Labeling | Approved |
| Oxycodone and Acetaminophen
ANDA #207574 |
Acetaminophen; Oxycodone Hydrochloride | Tablet; Oral | SUPPL-12 | Cerovene Inc | Labeling | Approved |
| Pylera
NDA #050786 |
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride | Capsule; Oral | SUPPL-27 | Labs Juvise | Labeling | Approved |
| Rybrevant
BLA #761210 |
Amivantamab-Vmjw | Injectable; Injection | SUPPL-4 | Janssen Biotech | Efficacy | Approved |
| Soliris
BLA #125166 |
Eculizumab | Injectable; Iv (Infusion) | SUPPL-447 | Alexion Pharm | Labeling | Approved |
| Ultomiris
BLA #761108 |
Ravulizumab-Cwvz | Injectable; Injection | SUPPL-37 | Alexion Pharm | Labeling | Approved |
September 18, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Amoxicillin
ANDA #065256 |
Amoxicillin | Tablet; Oral | SUPPL-27 | Aurobindo | Manufacturing (CMC) | Approved |
| Atenolol
ANDA #073457 |
Atenolol | Tablet; Oral | SUPPL-47 | Mylan | Labeling | Approved |
| Atenolol
ANDA #073457 |
Atenolol | Tablet; Oral | SUPPL-47 | Mylan | Labeling | Approved |
| Bumetanide
ANDA #212931 |
Bumetanide | Tablet; Oral | ORIG-1 | Appco | Approved | |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-11 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-12 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-11 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077033 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-12 | Heritage Pharma | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077141 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-3 | Natco Pharma Ltd | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077534 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-25 | Invagen Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #077534 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-25 | Invagen Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-40 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-39 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-40 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-39 | Torrent Pharms | Labeling | Approved |
| Citalopram Hydrobromide
ANDA #078216 |
Citalopram Hydrobromide | Tablet; Oral | SUPPL-40 | Torrent Pharms | Labeling | Approved |
| Rhopressa
NDA #208254 |
Netarsudil Mesylate | Solution/Drops; Ophthalmic | SUPPL-14 | Alcon Labs Inc | Labeling | Approved |
September 17, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bosentan
ANDA #205699 |
Bosentan | Tablet; Oral | SUPPL-4 | Endo Operations | REMS | Approved |
| Bosentan
ANDA #206987 |
Bosentan | Tablet; Oral | SUPPL-5 | Natco Pharma Ltd | REMS | Approved |
| Bosentan
ANDA #207110 |
Bosentan | Tablet; Oral | SUPPL-8 | Watson Labs Inc | REMS | Approved |
| Bosentan
ANDA #207760 |
Bosentan | Tablet; Oral | SUPPL-10 | Zydus Pharms | REMS | Approved |
| Bosentan
ANDA #209324 |
Bosentan | Tablet; Oral | SUPPL-10 | Sun Pharm | REMS | Approved |
| Bosentan
ANDA #209742 |
Bosentan | Tablet; Oral | SUPPL-9 | Amneal Pharms Co | REMS | Approved |
| Bumetanide
ANDA #217153 |
Bumetanide | Injectable; Injection | ORIG-1 | Lupin Ltd | Approved | |
| Dexamethasone
ANDA #218372 |
Dexamethasone | Tablet; Oral | ORIG-1 | Corepharma | Approved | |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-9 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-11 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-9 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-9 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-11 | Prinston Inc | Labeling | Approved |
| Ertugliflozin
ANDA #217071 |
Ertugliflozin | Tablet; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
| Evrysdi
NDA #213535 |
Risdiplam | For Solution; Oral | SUPPL-13 | Genentech Inc | Efficacy | Approved |
| Fasenra
BLA #761070 |
Benralizumab | Injectable; Injection | SUPPL-21 | Astrazeneca Ab | Efficacy | Approved |
| Keytruda
BLA #125514 |
Pembrolizumab | Solution; Intravenous | SUPPL-161 | Merck Sharp Dohme | Efficacy | Approved |
| Kisqali
NDA #209092 |
Ribociclib Succinate | Tablet; Oral | SUPPL-18 | Novartis | Efficacy | Approved |
| Kisqali Femara Co-Pack (Copackaged)
NDA #209935 |
Letrozole; Ribociclib Succinate | Tablet; Oral | SUPPL-27 | Novartis | Efficacy | Approved |
| Lactulose
ANDA #075911 |
Lactulose | Solution; Oral | SUPPL-12 | Xttrium Labs Inc | Manufacturing (CMC) | Approved |
| Metyrosine
ANDA #215541 |
Metyrosine | Capsule; Oral | ORIG-1 | Leading | Approved | |
| Prazosin Hydrochloride
ANDA #216727 |
Prazosin Hydrochloride | Capsule; Oral | ORIG-1 | Msn | Approved | |
| Tracleer
NDA #021290 |
Bosentan | Tablet; Oral | SUPPL-45 | Actelion | REMS | Approved |
| Tracleer
NDA #209279 |
Bosentan | Tablet, For Suspension; Oral | SUPPL-11 | Actelion | REMS | Approved |
September 16, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-42 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-45 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-42 | Watson Labs Inc | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #077285 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-45 | Watson Labs Inc | Labeling | Approved |
| Chemet
NDA #019998 |
Succimer | Capsule; Oral | SUPPL-23 | Recordati Rare | Labeling | Approved |
| Clobazam
ANDA #210039 |
Clobazam | Suspension; Oral | SUPPL-9 | Amneal | Labeling | Approved |
| Clobazam
ANDA #210039 |
Clobazam | Suspension; Oral | SUPPL-9 | Amneal | Labeling | Approved |
| Clobazam
ANDA #216008 |
Clobazam | Suspension; Oral | SUPPL-2 | Accord Hlthcare | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-4 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-4 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-7 | Mylan | Labeling | Approved |
| Emtricitabine and Tenofovir Disoproxil Fumarate
ANDA #206436 |
Emtricitabine; Tenofovir Disoproxil Fumarate | Tablet; Oral | SUPPL-8 | Mylan | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #212143 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-2 | Chia Tai Tianqing | Labeling | Approved |
| Fosaprepitant Dimeglumine
ANDA #212143 |
Fosaprepitant Dimeglumine | Powder; Intravenous | SUPPL-2 | Chia Tai Tianqing | Labeling | Approved |
| Iyuzeh
NDA #216472 |
Latanoprost | Solution/Drops; Ophthalmic | SUPPL-2 | Thea Pharma | Labeling | Approved |
| Ketoconazole
ANDA #218498 |
Ketoconazole | Shampoo; Topical | ORIG-1 | Novitium Pharma | Approved | |
| Lanreotide Acetate
NDA #215395 |
Lanreotide Acetate | Solution; Subcutaneous | SUPPL-7 | Invagen Pharms | Efficacy | Approved |
| Lansoprazole
ANDA #200816 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Lansoprazole
ANDA #200816 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Lansoprazole
ANDA #200816 |
Lansoprazole | Tablet, Orally Disintegrating, Delayed Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-11 | Amneal Pharms | Labeling | Approved |
| Levetiracetam
ANDA #090992 |
Levetiracetam | Solution; Oral | SUPPL-11 | Amneal Pharms | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-31 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-31 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-31 | Macleods Pharms Ltd | Labeling | Approved |
| Levofloxacin
ANDA #200839 |
Levofloxacin | Tablet; Oral | SUPPL-33 | Macleods Pharms Ltd | Labeling | Approved |
| Levothyroxine Sodium
ANDA #212399 |
Levothyroxine Sodium | Tablet; Oral | SUPPL-6 | Accord Hlthcare | Labeling | Approved |
| Levothyroxine Sodium
ANDA #212399 |
Levothyroxine Sodium | Tablet; Oral | SUPPL-8 | Accord Hlthcare | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202802 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Actavis Elizabeth | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202802 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Actavis Elizabeth | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202802 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Actavis Elizabeth | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202830 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Amneal | Labeling | Approved |
| Lisdexamfetamine Dimesylate
ANDA #202830 |
Lisdexamfetamine Dimesylate | Capsule; Oral | SUPPL-2 | Amneal | Labeling | Approved |
| Medroxyprogesterone Acetate
ANDA #040159 |
Medroxyprogesterone Acetate | Tablet; Oral | SUPPL-34 | Barr | Labeling | Approved |
| Medroxyprogesterone Acetate
ANDA #040159 |
Medroxyprogesterone Acetate | Tablet; Oral | SUPPL-34 | Barr | Labeling | Approved |
| Sacubitril and Valsartan
ANDA #213764 |
Sacubitril; Valsartan | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Sancuso
NDA #022198 |
Granisetron | Film, Extended Release; Transdermal | SUPPL-23 | Cumberland | Labeling | Approved |
| Sirolimus
ANDA #215080 |
Sirolimus | Solution; Oral | ORIG-1 | Hetero Labs Ltd V | Approved | |
| Timolol Maleate
ANDA #210640 |
Timolol Maleate | Solution, Gel Forming/Drops; Ophthalmic | ORIG-1 | Somerset Theraps Llc | Approved | |
| Zyclara
NDA #022483 |
Imiquimod | Cream; Topical | SUPPL-11 | Bausch | Labeling | Approved |
| Zyclara
NDA #022483 |
Imiquimod | Cream; Topical | SUPPL-11 | Bausch | Labeling | Approved |
September 13, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cimzia
BLA #125160 |
Certolizumab Pegol | Injectable; Injection | SUPPL-275 | Ucb Inc | Efficacy | Approved |
| Ebglyss
BLA #761306 |
Lebrikizumab-Lbkz | Injectable; Injection | ORIG-1 | Eli Lilly and Co | Type 1 - New Molecular Entity | Approved |
| Erlotinib Hydrochloride
ANDA #203843 |
Erlotinib Hydrochloride | Tablet; Oral | ORIG-1 | Hikma | Approved | |
| Fluoxetine Hydrochloride
ANDA #212683 |
Fluoxetine Hydrochloride | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Nelarabine
ANDA #216948 |
Nelarabine | Injectable; Intravenous | ORIG-1 | Msn | Approved | |
| Ocrevus Zunovo
BLA #761371 |
Ocrelizumab and Hyaluronidase-Ocsq | Injectable; Injection | ORIG-1 | Genentech Inc | Approved | |
| Prochlorperazine Edisylate
ANDA #212257 |
Prochlorperazine Edisylate | Injectable; Injection | ORIG-1 | Somerset Theraps Llc | Approved | |
| Qsymia
NDA #022580 |
Phentermine Hydrochloride; Topiramate | Capsule, Extended Release; Oral | SUPPL-25 | Vivus Llc | Efficacy | Approved |
September 12, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Braftovi
NDA #210496 |
Encorafenib | Capsule; Oral | SUPPL-16 | Array Biopharma Inc | Efficacy | Approved |
| Braftovi
NDA #210496 |
Encorafenib | Capsule; Oral | SUPPL-16 | Array Biopharma Inc | Efficacy | Approved |
| Ciprofloxacin Extended Release
ANDA #077809 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-9 | Ani Pharms | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #077809 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-9 | Ani Pharms | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078166 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-16 | Endo Operations | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078183 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-22 | Rising Pharma | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078183 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-24 | Rising Pharma | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078183 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-22 | Rising Pharma | Labeling | Approved |
| Ciprofloxacin Extended Release
ANDA #078183 |
Ciprofloxacin; Ciprofloxacin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-24 | Rising Pharma | Labeling | Approved |
| Clozaril
NDA #019758 |
Clozapine | Tablet; Oral | SUPPL-104 | Heritage Life | Labeling | Approved |
| Cyclobenzaprine Hydrochloride
ANDA #218936 |
Cyclobenzaprine Hydrochloride | Tablet; Oral | ORIG-1 | Graviti Pharms | Approved | |
| Diclofenac Sodium
ANDA #075910 |
Diclofenac Sodium | Tablet, Extended Release; Oral | SUPPL-30 | Actavis Elizabeth | Labeling | Approved |
| Diclofenac Sodium
ANDA #075910 |
Diclofenac Sodium | Tablet, Extended Release; Oral | SUPPL-30 | Actavis Elizabeth | Labeling | Approved |
| Diclofenac Sodium
ANDA #076152 |
Diclofenac Sodium | Tablet, Extended Release; Oral | SUPPL-15 | Aurobindo Pharma Usa | Labeling | Approved |
| Diclofenac Sodium
ANDA #076152 |
Diclofenac Sodium | Tablet, Extended Release; Oral | SUPPL-15 | Aurobindo Pharma Usa | Labeling | Approved |
| Diltiazem Hydrochloride
ANDA #074910 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-19 | Mylan | Labeling | Approved |
| Dupixent
BLA #761055 |
Dupilumab | Injectable; Injection | SUPPL-66 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Enbrel
BLA #103795 |
Etanercept | Syringe | SUPPL-5600 | Immunex | Labeling | Approved |
| Enbrel
BLA #103795 |
Etanercept | Syringe | SUPPL-5600 | Immunex | Labeling | Approved |
| Enbrel
BLA #103795 |
Etanercept | Vial; Subcutaneous | SUPPL-5600 | Immunex | Labeling | Approved |
| Enbrel
BLA #103795 |
Etanercept | Vial; Subcutaneous | SUPPL-5600 | Immunex | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #090242 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-4 | Fresenius Kabi Usa | Labeling | Approved |
| Gemcitabine Hydrochloride
ANDA #090242 |
Gemcitabine Hydrochloride | Injectable; Injection | SUPPL-4 | Fresenius Kabi Usa | Labeling | Approved |
| Invega Hafyera
NDA #207946 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-14 | Janssen Pharms | Labeling | Approved |
| Invega Hafyera
NDA #207946 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-15 | Janssen Pharms | Labeling | Approved |
| Invega Sustenna
NDA #022264 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-37 | Janssen Pharms | Labeling | Approved |
| Invega Trinza
NDA #207946 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-14 | Janssen Pharms | Labeling | Approved |
| Invega Trinza
NDA #207946 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-15 | Janssen Pharms | Labeling | Approved |
| Mektovi
NDA #210498 |
Binimetinib | Tablet; Oral | SUPPL-10 | Array Biopharma Inc | Efficacy | Approved |
| Mektovi
NDA #210498 |
Binimetinib | Tablet; Oral | SUPPL-10 | Array Biopharma Inc | Efficacy | Approved |
| Methotrexate
NDA #214121 |
Methotrexate | Solution; Intravenous | SUPPL-3 | Accord Hlthcare | Labeling | Approved |
| Naglazyme
BLA #125117 |
Galsulfase | Injectable; Injection | SUPPL-132 | Biomarin | Labeling | Approved |
| Paxlovid (Copackaged)
NDA #217188 |
Nirmatrelvir; Ritonavir | Tablet; Oral | SUPPL-6 | Pfizer | Labeling | Approved |
| Sabril
NDA #020427 |
Vigabatrin | Tablet; Oral | SUPPL-27 | Lundbeck Pharms Llc | REMS | Approved |
| Sabril
NDA #022006 |
Vigabatrin | For Solution; Oral | SUPPL-28 | Lundbeck Pharms Llc | REMS | Approved |
| Tecentriq Hybreza
BLA #761347 |
Atezolizumab and Hyaluronidase-Tqjs | Injectable; Injection | ORIG-1 | Genentech Inc | Type 3 - New Dosage Form | Approved |
| Ticagrelor
ANDA #210219 |
Ticagrelor | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Tentative Approval | |
| Vigabatrin
ANDA #208218 |
Vigabatrin | For Solution; Oral | SUPPL-15 | Endo Operations | REMS | Approved |
| Vigabatrin
ANDA #209822 |
Vigabatrin | Tablet; Oral | SUPPL-12 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin
ANDA #209824 |
Vigabatrin | For Solution; Oral | SUPPL-13 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin
ANDA #210042 |
Vigabatrin | Tablet; Oral | SUPPL-6 | Amneal Pharms | REMS | Approved |
| Vigabatrin
ANDA #210155 |
Vigabatrin | For Solution; Oral | SUPPL-19 | Amneal Pharms | REMS | Approved |
| Vigabatrin
ANDA #211481 |
Vigabatrin | For Solution; Oral | SUPPL-9 | Dr Reddys | REMS | Approved |
| Vigabatrin
ANDA #211539 |
Vigabatrin | Tablet; Oral | SUPPL-2 | Dr Reddys | REMS | Approved |
| Vigabatrin
ANDA #211592 |
Vigabatrin | For Solution; Oral | SUPPL-9 | Invagen Pharms | REMS | Approved |
| Vigabatrin
ANDA #213104 |
Vigabatrin | Tablet; Oral | SUPPL-2 | Hikma | REMS | Approved |
| Vigabatrin
ANDA #213375 |
Vigabatrin | For Solution; Oral | SUPPL-5 | Alkem Labs Ltd | REMS | Approved |
| Vigabatrin
ANDA #213390 |
Vigabatrin | For Solution; Oral | SUPPL-3 | Propel Pharma | REMS | Approved |
| Vigabatrin
ANDA #213469 |
Vigabatrin | For Solution; Oral | SUPPL-5 | Granules | REMS | Approved |
| Vigabatrin
ANDA #213519 |
Vigabatrin | For Solution; Oral | SUPPL-4 | Annora Pharma | REMS | Approved |
| Vigabatrin
ANDA #213899 |
Vigabatrin | For Solution; Oral | SUPPL-4 | Aurobindo Pharma Ltd | REMS | Approved |
| Vigabatrin
ANDA #214425 |
Vigabatrin | For Solution; Oral | SUPPL-4 | Accord Hlthcare | REMS | Approved |
| Vigabatrin
ANDA #214671 |
Vigabatrin | For Solution; Oral | SUPPL-1 | Zydus Lifesciences | REMS | Approved |
| Vigabatrin
ANDA #214749 |
Vigabatrin | Tablet; Oral | SUPPL-1 | Upsher Smith Labs | REMS | Approved |
| Vigabatrin
ANDA #214992 |
Vigabatrin | For Solution; Oral | SUPPL-3 | Dexcel | REMS | Approved |
| Vigabatrin
ANDA #215109 |
Vigabatrin | Tablet; Oral | SUPPL-3 | Dexcel | REMS | Approved |
| Vigabatrin
ANDA #215363 |
Vigabatrin | For Solution; Oral | SUPPL-2 | Msn | REMS | Approved |
| Vigabatrin
ANDA #215519 |
Vigabatrin | Tablet; Oral | SUPPL-1 | Propel Pharma | REMS | Approved |
| Vigabatrin
ANDA #215601 |
Vigabatrin | Tablet; Oral | SUPPL-3 | Aurobindo Pharma Ltd | REMS | Approved |
| Vigabatrin
ANDA #215707 |
Vigabatrin | Tablet; Oral | SUPPL-3 | Zydus Lifesciences | REMS | Approved |
| Vigadrone
ANDA #210196 |
Vigabatrin | For Solution; Oral | SUPPL-20 | Aucta | REMS | Approved |
| Vigafyde
NDA #217684 |
Vigabatrin | Solution; Oral | SUPPL-1 | Pyros Pharms | REMS | Approved |
| Vigpoder
ANDA #214961 |
Vigabatrin | For Solution; Oral | SUPPL-7 | Pyros Pharms | REMS | Approved |
| Zyrtec-D 12 Hour
NDA #021150 |
Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-22 | J and J Consumer Inc | Labeling | Approved |
September 11, 2024
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aleve
NDA #020204 |
Naproxen Sodium | Tablet; Oral | SUPPL-88 | Bayer | Labeling | Approved |
| Amiodarone Hydrochloride
ANDA #218253 |
Amiodarone Hydrochloride | Injectable; Injection | ORIG-1 | Zhejiang Poly Pharm | Approved | |
| Busulfan
ANDA #215235 |
Busulfan | Injectable; Injection | ORIG-1 | Prinston Inc | Approved | |
| Dabigatran Etexilate Mesylate
ANDA #208040 |
Dabigatran Etexilate Mesylate | Capsule; Oral | ORIG-2 | Alkem Labs Ltd | Approved | |
| Lenalidomide
ANDA #217281 |
Lenalidomide | Capsule; Oral | ORIG-1 | Novugen | Approved | |
| Tremfya
BLA #761061 |
Guselkumab | Injectable; Injection | SUPPL-21 | Janssen Biotech | Efficacy | Approved |
| Vumerity
NDA #211855 |
Diroximel Fumarate | Capsule, Delayed Release; Oral | SUPPL-17 | Biogen Inc | Manufacturing (CMC) | Approved |