Drugs@FDA: FDA-Approved Drugs
Recent New and Generic Drug Approvals
This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
February 25, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Thalomid
NDA #020785 |
Thalidomide | Capsule; Oral | SUPPL-69 | Celgene | Labeling | Approved |
February 24, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Ampyra
NDA #022250 |
Dalfampridine | Tablet, Extended Release; Oral | SUPPL-18 | Acorda | Labeling | Approved |
| Biktarvy
NDA #210251 |
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | Tablet; Oral | SUPPL-8 | Gilead Sciences Inc | Efficacy | Approved |
| Fludeoxyglucose F18
ANDA #204333 |
Fludeoxyglucose F-18 | Injectable; Intravenous | SUPPL-5 | Ma General Hosp | Labeling | Approved |
| Humira
BLA #125057 |
Adalimumab | Syringe | SUPPL-417 | Abbvie Inc | Efficacy | Approved |
| Humira
BLA #125057 |
Adalimumab | Vial | SUPPL-417 | Abbvie Inc | Efficacy | Approved |
| Hyrimoz
BLA #761071 |
Adalimumab-Adaz | Injectable; Injection | SUPPL-1 | Sandoz Inc | Labeling | Approved |
| Naloxegol
ANDA #212625 |
Naloxegol | Unknown | ORIG-1 | Msn Labs Pvt Ltd | Tentative Approval | |
| Nortriptyline Hydrochloride
ANDA #213441 |
Nortriptyline Hydrochloride | Capsule; Oral | ORIG-1 | Zydus | Approved | |
| Succinylcholine Chloride
ANDA #211432 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-6 | Amneal | Labeling | Approved |
February 23, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen, Aspirin and Caffeine
ANDA #214039 |
Acetaminophen; Aspirin; Caffeine | Tablet; Oral | ORIG-1 | Granules | Approved | |
| Everolimus
ANDA #210130 |
Everolimus | Tablet, For Suspension; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Everolimus
ANDA #210130 |
Everolimus | Tablet, For Suspension; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Ezetimibe and Simvastatin
ANDA #201890 |
Ezetimibe; Simvastatin | Tablet; Oral | SUPPL-10 | Ani Pharms Inc | Labeling | Approved |
| Ezetimibe and Simvastatin
ANDA #201890 |
Ezetimibe; Simvastatin | Tablet; Oral | SUPPL-10 | Ani Pharms Inc | Labeling | Approved |
| Ezetimibe and Simvastatin
ANDA #209222 |
Ezetimibe; Simvastatin | Tablet; Oral | SUPPL-8 | Alkem Labs Ltd | Labeling | Approved |
| Fludeoxyglucose F18
ANDA #204385 |
Fludeoxyglucose F-18 | Injectable; Intravenous | SUPPL-2 | Childrens Hosp Mi | Labeling | Approved |
| Pemazyre
NDA #213736 |
Pemigatinib | Tablet; Oral | SUPPL-1 | Incyte Corp | Labeling | Approved |
| Pemetrexed
NDA #214218 |
Pemetrexed | Injectable; Injection | ORIG-1 | Hospira Inc | Type 5 - New Formulation or New Manufacturer | Tentative Approval |
| Rufinamide
ANDA #213410 |
Rufinamide | Suspension; Oral | ORIG-1 | Alkem Labs Ltd | Approved |
February 22, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #211372 |
Acetazolamide | Tablet; Oral | ORIG-1 | Appco | Approved | |
| Exforge Hct
NDA #022314 |
Amlodipine Besylate; Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-36 | Novartis | Labeling | Approved |
| Ibuprofen
ANDA #211666 |
Ibuprofen | Suspension; Oral | ORIG-1 | Strides Pharma | Approved | |
| Libtayo
BLA #761097 |
Cemiplimab-Rwlc | Injectable; Intravenous | SUPPL-7 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Singulair
NDA #020829 |
Montelukast Sodium | Tablet; Oral | SUPPL-74 | Msd Merck Co | Labeling | Approved |
| Singulair
NDA #020830 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-76 | Msd Merck Co | Labeling | Approved |
| Singulair
NDA #021409 |
Montelukast Sodium | Granule; Oral | SUPPL-52 | Merck | Labeling | Approved |
| Spironolactone
ANDA #091426 |
Spironolactone | Tablet; Oral | SUPPL-17 | Amneal Pharms | Labeling | Approved |
| Sumatriptan
ANDA #214209 |
Sumatriptan | Spray; Nasal | ORIG-1 | Cipla | Approved | |
| Veklury
NDA #214787 |
Remdesivir | Powder; Intravenous | SUPPL-5 | Gilead Sciences Inc | Labeling | Approved |
| Veklury
NDA #214787 |
Remdesivir | Solution; Intravenous | SUPPL-5 | Gilead Sciences Inc | Labeling | Approved |
February 19, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Accuretic
NDA #020125 |
Hydrochlorothiazide; Quinapril Hydrochloride | Tablet; Oral | SUPPL-28 | Pfizer Pharms | Labeling | Approved |
| Aldactazide
NDA #012616 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-81 | Pfizer | Labeling | Approved |
| Amitriptyline Hydrochloride
ANDA #213999 |
Amitriptyline Hydrochloride | Tablet; Oral | ORIG-1 | Mankind Pharma | Approved | |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Lannett Co Inc | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Lannett Co Inc | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Lannett Co Inc | Labeling | Approved |
| Cefdinir
ANDA #210220 |
Cefdinir | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Cefdinir
ANDA #210534 |
Cefdinir | For Suspension; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Cefixime
ANDA #211775 |
Cefixime | For Suspension; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Dexmedetomidine Hydrochloride
ANDA #202126 |
Dexmedetomidine Hydrochloride | Injectable; Injection | SUPPL-5 | Sun Pharm Inds Inc | Labeling | Approved |
| Famotidine
ANDA #075786 |
Famotidine | Tablet; Oral | SUPPL-6 | Celltrion | Labeling | Approved |
| Halaven
NDA #201532 |
Eribulin Mesylate | Solution; Intravenous | SUPPL-20 | Eisai Inc | Labeling | Approved |
| Halaven
NDA #201532 |
Eribulin Mesylate | Solution; Intravenous | SUPPL-20 | Eisai Inc | Labeling | Approved |
| Imfinzi
BLA #761069 |
Durvalumab | Injectable; Injection | SUPPL-29 | Astrazeneca Uk Ltd | Efficacy | Approved |
| Lamotrigine
ANDA #203370 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-12 | Torrent | Labeling | Approved |
| Lamotrigine
ANDA #203370 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-12 | Torrent | Labeling | Approved |
| Linezolid
ANDA #210702 |
Linezolid | Tablet; Oral | SUPPL-4 | Celltrion | Labeling | Approved |
| Methadone Hydrochloride
ANDA #211228 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #211228 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
| Mucinex
NDA #021282 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-54 | Rb Hlth | Labeling | Approved |
| Mucinex Dm
NDA #021620 |
Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release; Oral | SUPPL-43 | Rb Hlth | Labeling | Approved |
| Oxymorphone Hydrochloride
ANDA #203601 |
Oxymorphone Hydrochloride | Tablet; Oral | SUPPL-3 | Avanthi Inc | Labeling | Approved |
| Oxymorphone Hydrochloride
ANDA #203601 |
Oxymorphone Hydrochloride | Tablet; Oral | SUPPL-3 | Avanthi Inc | Labeling | Approved |
| Potassium Citrate
ANDA #214426 |
Potassium Citrate | Tablet, Extended Release; Oral | ORIG-1 | Eywa | Approved |
February 18, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen
NDA #204957 |
Acetaminophen | Solution; Intravenous | ORIG-1 | B Braun Medical Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Azelastine Hydrochloride and Fluticasone Propionate
ANDA #208111 |
Azelastine Hydrochloride; Fluticasone Propionate | Spray, Metered; Nasal | ORIG-1 | Perrigo Uk Finco | Approved | |
| Clindamycin Phosphate In 0.9% Sodium Chloride
NDA #208083 |
Clindamycin Phosphate | Solution; Intravenous | SUPPL-4 | Baxter Hlthcare Corp | Labeling | Approved |
| Clozapine
ANDA #074949 |
Clozapine | Tablet; Oral | SUPPL-81 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-46 | Mylan | REMS | Approved |
| Clozapine
ANDA #075713 |
Clozapine | Tablet; Oral | SUPPL-50 | Sun Pharm Inds Inc | REMS | Approved |
| Clozapine
ANDA #076809 |
Clozapine | Tablet; Oral | SUPPL-44 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #090308 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-8 | Barr Labs Inc | REMS | Approved |
| Clozapine
ANDA #201824 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-13 | Mylan | REMS | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-8 | Accord Hlthcare | REMS | Approved |
| Clozapine
ANDA #203039 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-9 | Teva Pharms Usa | REMS | Approved |
| Clozapine
ANDA #203807 |
Clozapine | Tablet; Oral | SUPPL-10 | Mayne Pharma | REMS | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-9 | Aurobindo Pharma Ltd | REMS | Approved |
| Clozaril
NDA #019758 |
Clozapine | Tablet; Oral | SUPPL-96 | Heritage Life | REMS | Approved |
| Droxidopa
ANDA #211652 |
Droxidopa | Capsule; Oral | ORIG-1 | Lupin Pharms | Approved | |
| Droxidopa
ANDA #211726 |
Droxidopa | Capsule; Oral | ORIG-1 | Annora | Approved | |
| Droxidopa
ANDA #211741 |
Droxidopa | Capsule; Oral | ORIG-1 | Msn Pharms Inc | Approved | |
| Droxidopa
ANDA #211818 |
Droxidopa | Capsule; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Droxidopa
ANDA #212835 |
Droxidopa | Capsule; Oral | ORIG-1 | Hikma | Approved | |
| Droxidopa
ANDA #213162 |
Droxidopa | Capsule; Oral | ORIG-1 | Teva Pharms Usa Inc | Approved | |
| Droxidopa
ANDA #213661 |
Droxidopa | Capsule; Oral | ORIG-1 | Tasman Pharma | Approved | |
| Droxidopa
ANDA #213911 |
Droxidopa | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Droxidopa
ANDA #214017 |
Droxidopa | Capsule; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Droxidopa
ANDA #214384 |
Droxidopa | Capsule; Oral | ORIG-1 | Sun Pharm | Approved | |
| Droxidopa
ANDA #214387 |
Droxidopa | Capsule; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Droxidopa
ANDA #214391 |
Droxidopa | Capsule; Oral | ORIG-1 | Ajanta Pharma Ltd | Approved | |
| Ellence
NDA #050778 |
Epirubicin Hydrochloride | Injectable; Injection | SUPPL-26 | Pfizer Inc | Labeling | Approved |
| Famotidine
ANDA #077351 |
Famotidine | Tablet; Oral | SUPPL-23 | Perrigo R and D | Labeling | Approved |
| Famotidine
ANDA #077351 |
Famotidine | Tablet; Oral | SUPPL-23 | Perrigo R and D | Labeling | Approved |
| Methadone Hydrochloride
ANDA #207368 |
Methadone Hydrochloride | Concentrate; Oral | SUPPL-2 | Specgx Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #207368 |
Methadone Hydrochloride | Concentrate; Oral | SUPPL-2 | Specgx Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #208305 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-4 | Sun Pharm Industries | Labeling | Approved |
| Methadone Hydrochloride
ANDA #208305 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-4 | Sun Pharm Industries | Labeling | Approved |
| Olopatadine Hydrochloride
ANDA #209919 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-2 | Alembic Pharms Ltd | Labeling | Approved |
| Olopatadine Hydrochloride
ANDA #209919 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-2 | Alembic Pharms Ltd | Labeling | Approved |
| Piperacillin and Tazobactam
ANDA #065458 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | SUPPL-12 | Mylan Labs Ltd | Labeling | Approved |
| Piperacillin and Tazobactam
ANDA #203719 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | SUPPL-3 | Fresenius Kabi | Labeling | Approved |
| Qudexy Xr
NDA #205122 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-11 | Upsher Smith Labs | Labeling | Approved |
| Qudexy Xr
NDA #205122 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-11 | Upsher Smith Labs | Labeling | Approved |
| Versacloz
NDA #203479 |
Clozapine | Suspension; Oral | SUPPL-15 | Tasman Pharma | REMS | Approved |
February 17, 2021
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apremilast
ANDA #211819 |
Apremilast | Tablet; Oral | ORIG-1 | Unichem | Approved | |
| Brilinta
NDA #022433 |
Ticagrelor | Tablet; Oral | SUPPL-31 | Astrazeneca | Labeling | Approved |
| Epzicom
NDA #021652 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | SUPPL-28 | Viiv Hlthcare | Labeling | Approved |
| Epzicom
NDA #021652 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | SUPPL-28 | Viiv Hlthcare | Labeling | Approved |
| Estradiol
ANDA #206388 |
Estradiol | Tablet; Vaginal | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Estradiol
ANDA #206388 |
Estradiol | Tablet; Vaginal | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Estradiol
ANDA #210264 |
Estradiol | Tablet; Vaginal | SUPPL-1 | Glenmark Pharms Ltd | Labeling | Approved |
| Fosphenytoin Sodium
ANDA #078476 |
Fosphenytoin Sodium | Injectable; Injection | SUPPL-13 | Amneal | Labeling | Approved |
| Haloperidol
ANDA #071130 |
Haloperidol | Tablet; Oral | SUPPL-11 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #071130 |
Haloperidol | Tablet; Oral | SUPPL-11 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #071131 |
Haloperidol | Tablet; Oral | SUPPL-11 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #071132 |
Haloperidol | Tablet; Oral | SUPPL-10 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Levonorgestrel and Ethinyl Estradiol
ANDA #202970 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-1 | Mylan Labs Ltd | Labeling | Approved |
| Levonorgestrel and Ethinyl Estradiol
ANDA #202970 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-1 | Mylan Labs Ltd | Labeling | Approved |
| Risedronate Sodium
ANDA #205280 |
Risedronate Sodium | Tablet; Oral | SUPPL-1 | Orchid Hlthcare | Labeling | Approved |
| Risedronate Sodium
ANDA #205280 |
Risedronate Sodium | Tablet; Oral | SUPPL-1 | Orchid Hlthcare | Labeling | Approved |
| Sumatriptan
ANDA #208967 |
Sumatriptan | Spray; Nasal | ORIG-1 | Pharmaserve Nw | Approved | |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-33 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-34 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-35 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-36 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-37 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-38 | Genentech Inc | Efficacy | Approved |
| Trizivir
NDA #021205 |
Abacavir Sulfate; Lamivudine; Zidovudine | Tablet; Oral | SUPPL-41 | Viiv Hlthcare | Labeling | Approved |
February 25, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Thalomid
NDA #020785 |
Thalidomide | Capsule; Oral | SUPPL-69 | Celgene | Labeling | Approved |
February 24, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Ampyra
NDA #022250 |
Dalfampridine | Tablet, Extended Release; Oral | SUPPL-18 | Acorda | Labeling | Approved |
| Biktarvy
NDA #210251 |
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | Tablet; Oral | SUPPL-8 | Gilead Sciences Inc | Efficacy | Approved |
| Fludeoxyglucose F18
ANDA #204333 |
Fludeoxyglucose F-18 | Injectable; Intravenous | SUPPL-5 | Ma General Hosp | Labeling | Approved |
| Humira
BLA #125057 |
Adalimumab | Syringe | SUPPL-417 | Abbvie Inc | Efficacy | Approved |
| Humira
BLA #125057 |
Adalimumab | Vial | SUPPL-417 | Abbvie Inc | Efficacy | Approved |
| Hyrimoz
BLA #761071 |
Adalimumab-Adaz | Injectable; Injection | SUPPL-1 | Sandoz Inc | Labeling | Approved |
| Naloxegol
ANDA #212625 |
Naloxegol | Unknown | ORIG-1 | Msn Labs Pvt Ltd | Tentative Approval | |
| Nortriptyline Hydrochloride
ANDA #213441 |
Nortriptyline Hydrochloride | Capsule; Oral | ORIG-1 | Zydus | Approved | |
| Succinylcholine Chloride
ANDA #211432 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-6 | Amneal | Labeling | Approved |
February 23, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen, Aspirin and Caffeine
ANDA #214039 |
Acetaminophen; Aspirin; Caffeine | Tablet; Oral | ORIG-1 | Granules | Approved | |
| Everolimus
ANDA #210130 |
Everolimus | Tablet, For Suspension; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Everolimus
ANDA #210130 |
Everolimus | Tablet, For Suspension; Oral | SUPPL-2 | Mylan | Labeling | Approved |
| Ezetimibe and Simvastatin
ANDA #201890 |
Ezetimibe; Simvastatin | Tablet; Oral | SUPPL-10 | Ani Pharms Inc | Labeling | Approved |
| Ezetimibe and Simvastatin
ANDA #201890 |
Ezetimibe; Simvastatin | Tablet; Oral | SUPPL-10 | Ani Pharms Inc | Labeling | Approved |
| Ezetimibe and Simvastatin
ANDA #209222 |
Ezetimibe; Simvastatin | Tablet; Oral | SUPPL-8 | Alkem Labs Ltd | Labeling | Approved |
| Fludeoxyglucose F18
ANDA #204385 |
Fludeoxyglucose F-18 | Injectable; Intravenous | SUPPL-2 | Childrens Hosp Mi | Labeling | Approved |
| Pemazyre
NDA #213736 |
Pemigatinib | Tablet; Oral | SUPPL-1 | Incyte Corp | Labeling | Approved |
| Pemetrexed
NDA #214218 |
Pemetrexed | Injectable; Injection | ORIG-1 | Hospira Inc | Type 5 - New Formulation or New Manufacturer | Tentative Approval |
| Rufinamide
ANDA #213410 |
Rufinamide | Suspension; Oral | ORIG-1 | Alkem Labs Ltd | Approved |
February 22, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetazolamide
ANDA #211372 |
Acetazolamide | Tablet; Oral | ORIG-1 | Appco | Approved | |
| Exforge Hct
NDA #022314 |
Amlodipine Besylate; Hydrochlorothiazide; Valsartan | Tablet; Oral | SUPPL-36 | Novartis | Labeling | Approved |
| Ibuprofen
ANDA #211666 |
Ibuprofen | Suspension; Oral | ORIG-1 | Strides Pharma | Approved | |
| Libtayo
BLA #761097 |
Cemiplimab-Rwlc | Injectable; Intravenous | SUPPL-7 | Regeneron Pharmaceuticals | Efficacy | Approved |
| Singulair
NDA #020829 |
Montelukast Sodium | Tablet; Oral | SUPPL-74 | Msd Merck Co | Labeling | Approved |
| Singulair
NDA #020830 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-76 | Msd Merck Co | Labeling | Approved |
| Singulair
NDA #021409 |
Montelukast Sodium | Granule; Oral | SUPPL-52 | Merck | Labeling | Approved |
| Spironolactone
ANDA #091426 |
Spironolactone | Tablet; Oral | SUPPL-17 | Amneal Pharms | Labeling | Approved |
| Sumatriptan
ANDA #214209 |
Sumatriptan | Spray; Nasal | ORIG-1 | Cipla | Approved | |
| Veklury
NDA #214787 |
Remdesivir | Powder; Intravenous | SUPPL-5 | Gilead Sciences Inc | Labeling | Approved |
| Veklury
NDA #214787 |
Remdesivir | Solution; Intravenous | SUPPL-5 | Gilead Sciences Inc | Labeling | Approved |
February 19, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Accuretic
NDA #020125 |
Hydrochlorothiazide; Quinapril Hydrochloride | Tablet; Oral | SUPPL-28 | Pfizer Pharms | Labeling | Approved |
| Aldactazide
NDA #012616 |
Hydrochlorothiazide; Spironolactone | Tablet; Oral | SUPPL-81 | Pfizer | Labeling | Approved |
| Amitriptyline Hydrochloride
ANDA #213999 |
Amitriptyline Hydrochloride | Tablet; Oral | ORIG-1 | Mankind Pharma | Approved | |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Lannett Co Inc | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Lannett Co Inc | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205022 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-9 | Lannett Co Inc | Labeling | Approved |
| Cefdinir
ANDA #210220 |
Cefdinir | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Cefdinir
ANDA #210534 |
Cefdinir | For Suspension; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Cefixime
ANDA #211775 |
Cefixime | For Suspension; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Dexmedetomidine Hydrochloride
ANDA #202126 |
Dexmedetomidine Hydrochloride | Injectable; Injection | SUPPL-5 | Sun Pharm Inds Inc | Labeling | Approved |
| Famotidine
ANDA #075786 |
Famotidine | Tablet; Oral | SUPPL-6 | Celltrion | Labeling | Approved |
| Halaven
NDA #201532 |
Eribulin Mesylate | Solution; Intravenous | SUPPL-20 | Eisai Inc | Labeling | Approved |
| Halaven
NDA #201532 |
Eribulin Mesylate | Solution; Intravenous | SUPPL-20 | Eisai Inc | Labeling | Approved |
| Imfinzi
BLA #761069 |
Durvalumab | Injectable; Injection | SUPPL-29 | Astrazeneca Uk Ltd | Efficacy | Approved |
| Lamotrigine
ANDA #203370 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-12 | Torrent | Labeling | Approved |
| Lamotrigine
ANDA #203370 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-12 | Torrent | Labeling | Approved |
| Linezolid
ANDA #210702 |
Linezolid | Tablet; Oral | SUPPL-4 | Celltrion | Labeling | Approved |
| Methadone Hydrochloride
ANDA #211228 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #211228 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-1 | Ascent Pharms Inc | Labeling | Approved |
| Mucinex
NDA #021282 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-54 | Rb Hlth | Labeling | Approved |
| Mucinex Dm
NDA #021620 |
Dextromethorphan Hydrobromide; Guaifenesin | Tablet, Extended Release; Oral | SUPPL-43 | Rb Hlth | Labeling | Approved |
| Oxymorphone Hydrochloride
ANDA #203601 |
Oxymorphone Hydrochloride | Tablet; Oral | SUPPL-3 | Avanthi Inc | Labeling | Approved |
| Oxymorphone Hydrochloride
ANDA #203601 |
Oxymorphone Hydrochloride | Tablet; Oral | SUPPL-3 | Avanthi Inc | Labeling | Approved |
| Potassium Citrate
ANDA #214426 |
Potassium Citrate | Tablet, Extended Release; Oral | ORIG-1 | Eywa | Approved |
February 18, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen
NDA #204957 |
Acetaminophen | Solution; Intravenous | ORIG-1 | B Braun Medical Inc | Type 5 - New Formulation or New Manufacturer | Approved |
| Azelastine Hydrochloride and Fluticasone Propionate
ANDA #208111 |
Azelastine Hydrochloride; Fluticasone Propionate | Spray, Metered; Nasal | ORIG-1 | Perrigo Uk Finco | Approved | |
| Clindamycin Phosphate In 0.9% Sodium Chloride
NDA #208083 |
Clindamycin Phosphate | Solution; Intravenous | SUPPL-4 | Baxter Hlthcare Corp | Labeling | Approved |
| Clozapine
ANDA #074949 |
Clozapine | Tablet; Oral | SUPPL-81 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #075417 |
Clozapine | Tablet; Oral | SUPPL-46 | Mylan | REMS | Approved |
| Clozapine
ANDA #075713 |
Clozapine | Tablet; Oral | SUPPL-50 | Sun Pharm Inds Inc | REMS | Approved |
| Clozapine
ANDA #076809 |
Clozapine | Tablet; Oral | SUPPL-44 | Ivax Sub Teva Pharms | REMS | Approved |
| Clozapine
ANDA #090308 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-8 | Barr Labs Inc | REMS | Approved |
| Clozapine
ANDA #201824 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-13 | Mylan | REMS | Approved |
| Clozapine
ANDA #202873 |
Clozapine | Tablet; Oral | SUPPL-8 | Accord Hlthcare | REMS | Approved |
| Clozapine
ANDA #203039 |
Clozapine | Tablet, Orally Disintegrating; Oral | SUPPL-9 | Teva Pharms Usa | REMS | Approved |
| Clozapine
ANDA #203807 |
Clozapine | Tablet; Oral | SUPPL-10 | Mayne Pharma | REMS | Approved |
| Clozapine
ANDA #206433 |
Clozapine | Tablet; Oral | SUPPL-9 | Aurobindo Pharma Ltd | REMS | Approved |
| Clozaril
NDA #019758 |
Clozapine | Tablet; Oral | SUPPL-96 | Heritage Life | REMS | Approved |
| Droxidopa
ANDA #211652 |
Droxidopa | Capsule; Oral | ORIG-1 | Lupin Pharms | Approved | |
| Droxidopa
ANDA #211726 |
Droxidopa | Capsule; Oral | ORIG-1 | Annora | Approved | |
| Droxidopa
ANDA #211741 |
Droxidopa | Capsule; Oral | ORIG-1 | Msn Pharms Inc | Approved | |
| Droxidopa
ANDA #211818 |
Droxidopa | Capsule; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Droxidopa
ANDA #212835 |
Droxidopa | Capsule; Oral | ORIG-1 | Hikma | Approved | |
| Droxidopa
ANDA #213162 |
Droxidopa | Capsule; Oral | ORIG-1 | Teva Pharms Usa Inc | Approved | |
| Droxidopa
ANDA #213661 |
Droxidopa | Capsule; Oral | ORIG-1 | Tasman Pharma | Approved | |
| Droxidopa
ANDA #213911 |
Droxidopa | Capsule; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Droxidopa
ANDA #214017 |
Droxidopa | Capsule; Oral | ORIG-1 | Sciegen Pharms Inc | Approved | |
| Droxidopa
ANDA #214384 |
Droxidopa | Capsule; Oral | ORIG-1 | Sun Pharm | Approved | |
| Droxidopa
ANDA #214387 |
Droxidopa | Capsule; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Droxidopa
ANDA #214391 |
Droxidopa | Capsule; Oral | ORIG-1 | Ajanta Pharma Ltd | Approved | |
| Ellence
NDA #050778 |
Epirubicin Hydrochloride | Injectable; Injection | SUPPL-26 | Pfizer Inc | Labeling | Approved |
| Famotidine
ANDA #077351 |
Famotidine | Tablet; Oral | SUPPL-23 | Perrigo R and D | Labeling | Approved |
| Famotidine
ANDA #077351 |
Famotidine | Tablet; Oral | SUPPL-23 | Perrigo R and D | Labeling | Approved |
| Methadone Hydrochloride
ANDA #207368 |
Methadone Hydrochloride | Concentrate; Oral | SUPPL-2 | Specgx Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #207368 |
Methadone Hydrochloride | Concentrate; Oral | SUPPL-2 | Specgx Llc | Labeling | Approved |
| Methadone Hydrochloride
ANDA #208305 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-4 | Sun Pharm Industries | Labeling | Approved |
| Methadone Hydrochloride
ANDA #208305 |
Methadone Hydrochloride | Tablet; Oral | SUPPL-4 | Sun Pharm Industries | Labeling | Approved |
| Olopatadine Hydrochloride
ANDA #209919 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-2 | Alembic Pharms Ltd | Labeling | Approved |
| Olopatadine Hydrochloride
ANDA #209919 |
Olopatadine Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-2 | Alembic Pharms Ltd | Labeling | Approved |
| Piperacillin and Tazobactam
ANDA #065458 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | SUPPL-12 | Mylan Labs Ltd | Labeling | Approved |
| Piperacillin and Tazobactam
ANDA #203719 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | SUPPL-3 | Fresenius Kabi | Labeling | Approved |
| Qudexy Xr
NDA #205122 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-11 | Upsher Smith Labs | Labeling | Approved |
| Qudexy Xr
NDA #205122 |
Topiramate | Capsule, Extended Release; Oral | SUPPL-11 | Upsher Smith Labs | Labeling | Approved |
| Versacloz
NDA #203479 |
Clozapine | Suspension; Oral | SUPPL-15 | Tasman Pharma | REMS | Approved |
February 17, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Apremilast
ANDA #211819 |
Apremilast | Tablet; Oral | ORIG-1 | Unichem | Approved | |
| Brilinta
NDA #022433 |
Ticagrelor | Tablet; Oral | SUPPL-31 | Astrazeneca | Labeling | Approved |
| Epzicom
NDA #021652 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | SUPPL-28 | Viiv Hlthcare | Labeling | Approved |
| Epzicom
NDA #021652 |
Abacavir Sulfate; Lamivudine | Tablet; Oral | SUPPL-28 | Viiv Hlthcare | Labeling | Approved |
| Estradiol
ANDA #206388 |
Estradiol | Tablet; Vaginal | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Estradiol
ANDA #206388 |
Estradiol | Tablet; Vaginal | SUPPL-5 | Teva Pharms Usa | Labeling | Approved |
| Estradiol
ANDA #210264 |
Estradiol | Tablet; Vaginal | SUPPL-1 | Glenmark Pharms Ltd | Labeling | Approved |
| Fosphenytoin Sodium
ANDA #078476 |
Fosphenytoin Sodium | Injectable; Injection | SUPPL-13 | Amneal | Labeling | Approved |
| Haloperidol
ANDA #071130 |
Haloperidol | Tablet; Oral | SUPPL-11 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #071130 |
Haloperidol | Tablet; Oral | SUPPL-11 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #071131 |
Haloperidol | Tablet; Oral | SUPPL-11 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Haloperidol
ANDA #071132 |
Haloperidol | Tablet; Oral | SUPPL-10 | Cycle Pharms Ltd | Manufacturing (CMC) | Approved |
| Levonorgestrel and Ethinyl Estradiol
ANDA #202970 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-1 | Mylan Labs Ltd | Labeling | Approved |
| Levonorgestrel and Ethinyl Estradiol
ANDA #202970 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral-28 | SUPPL-1 | Mylan Labs Ltd | Labeling | Approved |
| Risedronate Sodium
ANDA #205280 |
Risedronate Sodium | Tablet; Oral | SUPPL-1 | Orchid Hlthcare | Labeling | Approved |
| Risedronate Sodium
ANDA #205280 |
Risedronate Sodium | Tablet; Oral | SUPPL-1 | Orchid Hlthcare | Labeling | Approved |
| Sumatriptan
ANDA #208967 |
Sumatriptan | Spray; Nasal | ORIG-1 | Pharmaserve Nw | Approved | |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-33 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-34 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-35 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-36 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-37 | Genentech Inc | Efficacy | Approved |
| Tecentriq
BLA #761034 |
Atezolizumab | Injectable; Injection | SUPPL-38 | Genentech Inc | Efficacy | Approved |
| Trizivir
NDA #021205 |
Abacavir Sulfate; Lamivudine; Zidovudine | Tablet; Oral | SUPPL-41 | Viiv Hlthcare | Labeling | Approved |
February 16, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Asmanex Twisthaler
NDA #021067 |
Mometasone Furoate | Powder; Inhalation | SUPPL-32 | Merck Sharp Dohme | Labeling | Approved |
| Asmanex Twisthaler
NDA #021067 |
Mometasone Furoate | Powder; Inhalation | SUPPL-32 | Merck Sharp Dohme | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201760 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-15 | Sun Pharm | Labeling | Approved |
| Buprenorphine Hydrochloride
ANDA #201760 |
Buprenorphine Hydrochloride | Tablet; Sublingual | SUPPL-15 | Sun Pharm | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #207000 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-7 | Specgx Llc | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #207000 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | SUPPL-7 | Specgx Llc | Labeling | Approved |
| Cerebyx
NDA #020450 |
Fosphenytoin Sodium | Injectable; Injection | SUPPL-42 | Parke Davis | Labeling | Approved |
| Dilantin-125
NDA #008762 |
Phenytoin | Suspension; Oral | SUPPL-65 | Upjohn | Labeling | Approved |
| Dilantin-30
NDA #008762 |
Phenytoin | Suspension; Oral | SUPPL-65 | Upjohn | Labeling | Approved |
| Entresto
NDA #207620 |
Sacubitril; Valsartan | Tablet; Oral | SUPPL-18 | Novartis Pharms Corp | Efficacy | Approved |
| Isoproterenol Hydrochloride
ANDA #210845 |
Isoproterenol Hydrochloride | Injectable; Injection | ORIG-1 | Micro Labs | Approved | |
| Paroxetine Hydrochloride
ANDA #213485 |
Paroxetine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Cspc Ouyi | Approved | |
| Phenytoin Sodium
ANDA #040573 |
Phenytoin Sodium | Injectable; Injection | SUPPL-13 | Acella | Labeling | Approved |
| Phenytoin Sodium
ANDA #040781 |
Phenytoin Sodium | Injectable; Injection | SUPPL-7 | Am Regent | Labeling | Approved |
| Phenytoin Sodium
ANDA #084307 |
Phenytoin Sodium | Injectable; Injection | SUPPL-62 | West-Ward Pharms Int | Labeling | Approved |
| Piperacillin and Tazobactam
ANDA #208674 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | ORIG-1 | Sagent Pharms Inc | Approved | |
| Piperacillin and Tazobactam
ANDA #208675 |
Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | ORIG-1 | Sagent Pharms Inc | Approved | |
| Potassium Chloride
ANDA #214686 |
Potassium Chloride | Capsule, Extended Release; Oral | ORIG-1 | Granules | Approved | |
| Pravastatin Sodium
ANDA #076056 |
Pravastatin Sodium | Tablet; Oral | SUPPL-21 | Teva | Labeling | Approved |
| Sotalol Hydrochloride
ANDA #075663 |
Sotalol Hydrochloride | Tablet; Oral | SUPPL-3 | Impax Pharms | Labeling | Approved |
| Sotalol Hydrochloride
ANDA #075725 |
Sotalol Hydrochloride | Tablet; Oral | SUPPL-8 | Mylan | Labeling | Approved |
February 12, 2021
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aminocaproic Acid
ANDA #213928 |
Aminocaproic Acid | Tablet; Oral | ORIG-1 | Leading Pharma Llc | Approved | |
| Cosela
NDA #214200 |
Trilaciclib Dihydrochloride | Injectable; Iv (Infusion) | ORIG-1 | G1 Therapeutics Inc | Type 1 - New Molecular Entity | Approved |
| Daptomycin
NDA #209949 |
Daptomycin | Powder; Iv (Infusion) | SUPPL-6 | Xellia Pharms Aps | Efficacy | Tentative Approval |
| Invega
NDA #021999 |
Paliperidone | Tablet, Extended Release; Oral | SUPPL-37 | Janssen Pharms | Labeling | Approved |
| Invega Sustenna
NDA #022264 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-30 | Janssen Pharms | Labeling | Approved |
| Invega Trinza
NDA #207946 |
Paliperidone Palmitate | Suspension, Extended Release; Intramuscular | SUPPL-9 | Janssen Pharms | Labeling | Approved |
| Jevtana Kit
NDA #201023 |
Cabazitaxel | Solution; Intravenous | SUPPL-25 | Sanofi Aventis Us | Labeling | Approved |
| Jevtana Kit
NDA #201023 |
Cabazitaxel | Solution; Intravenous | SUPPL-25 | Sanofi Aventis Us | Labeling | Approved |
| Lupron Depot
NDA #019943 |
Leuprolide Acetate | Injectable; Injection | SUPPL-35 | Abbvie Endocrine Inc | Labeling | Approved |
| Lupron Depot
NDA #020011 |
Leuprolide Acetate | Injectable; Injection | SUPPL-42 | Abbvie Endocrine Inc | Labeling | Approved |
| Metoprolol Succinate
ANDA #213854 |
Metoprolol Succinate | Tablet, Extended Release; Oral | ORIG-1 | Yichang Humanwell | Approved | |
| Morphine Sulfate
ANDA #211454 |
Morphine Sulfate | Solution; Oral | ORIG-1 | Winder Labs Llc | Approved | |
| Pentolair
ANDA #040075 |
Cyclopentolate Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-25 | Bausch and Lomb | Labeling | Approved |
| Risperdal
NDA #020272 |
Risperidone | Tablet; Oral | SUPPL-83 | Janssen Pharms | Labeling | Approved |
| Risperdal
NDA #020588 |
Risperidone | Solution; Oral | SUPPL-71 | Janssen Pharms | Labeling | Approved |
| Risperdal
NDA #021444 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-57 | Janssen Pharms | Labeling | Approved |
| Risperdal Consta
NDA #021346 |
Risperidone | Injectable; Intramuscular | SUPPL-61 | Janssen Pharms | Labeling | Approved |
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