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.
January 17, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen and Ibuprofen
ANDA #217241 |
Acetaminophen; Ibuprofen | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Dasatinib
ANDA #217217 |
Dasatinib | Tablet; Oral | ORIG-1 | Biocon Pharma Ltd | Tentative Approval | |
| Datroway
BLA #761394 |
Datopotamab Deruxtecan-Dlnk | Injectable; Iv (Infusion) | ORIG-1 | Daiichi Sankyo Inc | Type 1 - New Molecular Entity | Approved |
| Elelyso
BLA #022458 |
Taliglucerase Alfa | Powder; Intravenous | SUPPL-33 | Pfizer | Labeling | Approved |
January 16, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Artesunate
NDA #213036 |
Artesunate | Powder; Intravenous | SUPPL-8 | Amivas | Labeling | Approved |
| Brynovin
NDA #219122 |
Sitagliptin | Solution; Oral | ORIG-1 | Azurity | Type 3 - New Dosage Form | Approved |
| Calquence
NDA #210259 |
Acalabrutinib | Capsule; Oral | SUPPL-11 | Astrazeneca | Efficacy | Approved |
| Calquence
NDA #216387 |
Acalabrutinib Maleate | Tablet; Oral | SUPPL-5 | Astrazeneca | Efficacy | Approved |
| Carbamazepine
ANDA #219072 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Yichang Humanwell | Approved | |
| Diltiazem Hydrochloride
ANDA #208783 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Novast Labs | Labeling | Approved |
| Diltiazem Hydrochloride
ANDA #208783 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Novast Labs | Labeling | Approved |
| Ephedrine Sulfate
ANDA #218211 |
Ephedrine Sulfate | Solution; Intravenous | ORIG-1 | Gland Pharma Ltd | Approved | |
| Haloperidol
ANDA #078347 |
Haloperidol Lactate | Injectable; Injection | SUPPL-16 | Mylan Labs Ltd | Labeling | Approved |
| Idhifa
NDA #209606 |
Enasidenib Mesylate | Tablet; Oral | SUPPL-7 | Bristol Myers Squibb | Labeling | Approved |
| Levetiracetam In Sodium Chloride
ANDA #219562 |
Levetiracetam | Injectable; Intravenous | ORIG-1 | Caplin | Approved | |
| Linezolid
ANDA #205517 |
Linezolid | Tablet; Oral | SUPPL-14 | Alkem Labs Ltd | Labeling | Approved |
| Lumakras
NDA #214665 |
Sotorasib | Tablet; Oral | SUPPL-9 | Amgen Inc | Efficacy | Approved |
| Naloxone Hydrochloride
ANDA #213843 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-6 | Mylan Labs Ltd | Labeling | Approved |
| Pantoprazole Sodium
ANDA #219087 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | ORIG-1 | Graviti Pharms | Approved | |
| Pemetrexed Disodium
NDA #214408 |
Pemetrexed Disodium | Solution; Intravenous | SUPPL-5 | Accord Hlthcare | Labeling | Approved |
| Rifaximin
ANDA #218862 |
Rifaximin | Tablet; Oral | ORIG-1 | Amneal Eu Ltd | Tentative Approval | |
| Sitagliptin; Metformin Hydrochloride
ANDA #214685 |
Sitagliptin;Metformin Hydrochloride | Tablet; Oral | ORIG-1 | Dr Reddys Labs Ltd | Tentative Approval | |
| Ticagrelor
ANDA #211498 |
Ticagrelor | Tablet; Oral | ORIG-1 | Taro Pharm Inds Ltd | Tentative Approval | |
| Vectibix
BLA #125147 |
Panitumumab | Injectable; Iv (Infusion) | SUPPL-213 | Amgen | Efficacy | Approved |
January 15, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Celecoxib
ANDA #208701 |
Celecoxib | Capsule; Oral | SUPPL-3 | Cadila Pharms Ltd | Labeling | Approved |
| Desvenlafaxine Succinate
ANDA #211427 |
Desvenlafaxine Succinate | Tablet, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Dexmethylphenidate Hydrochloride
ANDA #215523 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Ascent Pharms Inc | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #215523 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Ascent Pharms Inc | Labeling | Approved |
| Eptifibatide
ANDA #208554 |
Eptifibatide | Injectable; Injection | SUPPL-4 | Baxter Hlthcare Corp | Labeling | Approved |
| Margenza
BLA #761150 |
Margetuximab-Cmkb | Injectable; Injection | SUPPL-11 | Macrogenics Inc | Labeling | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Injectable; Subcutaneous | SUPPL-3 | Eli Lilly and Co | Efficacy | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Injectable; Subcutaneous | SUPPL-2 | Eli Lilly and Co | Efficacy | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Vial; Single-Use | SUPPL-3 | Eli Lilly and Co | Efficacy | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Vial; Single-Use | SUPPL-2 | Eli Lilly and Co | Efficacy | Approved |
| Telmisartan
ANDA #203986 |
Telmisartan | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Trifluoperazine Hydrochloride
ANDA #085785 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-84 | Sandoz | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085786 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-92 | Sandoz | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085788 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-87 | Sandoz | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085789 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-88 | Sandoz | Labeling | Approved |
January 14, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Novast Labs | Labeling | Approved |
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Novast Labs | Labeling | Approved |
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Novast Labs | Labeling | Approved |
| Carbamazepine
ANDA #217277 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Carbidopa and Levodopa
ANDA #218939 |
Carbidopa; Levodopa | Tablet; Oral | ORIG-1 | Ascent Pharms Inc | Approved | |
| Dimethyl Fumarate
ANDA #210226 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-5 | Lupin | Labeling | Approved |
| Dimethyl Fumarate
ANDA #210226 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-5 | Lupin | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-25 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-27 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-25 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-27 | Aurobindo Pharma Ltd | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-12 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-17 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-12 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-17 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-19 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-20 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-22 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-24 | Inforlife | Labeling | Approved |
| Ipratropium Bromide
ANDA #219222 |
Ipratropium Bromide | Spray, Metered; Nasal | ORIG-1 | Rubicon | Approved | |
| Methotrexate Sodium Preservative Free
ANDA #040716 |
Methotrexate Sodium | Injectable; Injection | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040716 |
Methotrexate Sodium | Injectable; Injection | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040767 |
Methotrexate Sodium | Injectable; Injection | SUPPL-12 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040767 |
Methotrexate Sodium | Injectable; Injection | SUPPL-13 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040768 |
Methotrexate Sodium | Injectable; Injection | SUPPL-14 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040768 |
Methotrexate Sodium | Injectable; Injection | SUPPL-15 | Accord Hlthcare | Labeling | Approved |
| Nitrofurantoin
ANDA #208909 |
Nitrofurantoin | Suspension; Oral | ORIG-1 | Appco | Approved | |
| Risperidone
ANDA #076996 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-3 | Actavis Labs Fl Inc | Labeling | Approved |
| Risperidone
ANDA #076996 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-3 | Actavis Labs Fl Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-13 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-13 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-7 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-22 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-10 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-3 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-7 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-10 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-22 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-3 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-7 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-10 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-22 | Umedica | Labeling | Approved |
| Succinylcholine Chloride
ANDA #215022 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-1 | Sagent Pharms Inc | Labeling | Approved |
| Succinylcholine Chloride
ANDA #215022 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-1 | Sagent Pharms Inc | Labeling | Approved |
| Succinylcholine Chloride
ANDA #215022 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-2 | Sagent Pharms Inc | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #040209 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-21 | Mylan | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085787 |
Trifluoperazine Hydrochloride | Concentrate; Oral | SUPPL-32 | Chartwell Rx | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208228 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208228 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Zolpidem Tartrate
ANDA #077903 |
Zolpidem Tartrate | Tablet; Oral | SUPPL-34 | Torrent Pharms | Labeling | Approved |
| Zolpidem Tartrate
ANDA #077903 |
Zolpidem Tartrate | Tablet; Oral | SUPPL-34 | Torrent Pharms | Labeling | Approved |
January 13, 2025
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aripiprazole
ANDA #202102 |
Aripiprazole | Tablet, Orally Disintegrating; Oral | SUPPL-25 | Alembic | Labeling | Approved |
| Aripiprazole
ANDA #202102 |
Aripiprazole | Tablet, Orally Disintegrating; Oral | SUPPL-25 | Alembic | Labeling | Approved |
| Aripiprazole
ANDA #203906 |
Aripiprazole | Solution; Oral | SUPPL-15 | Amneal Pharms | Labeling | Approved |
| Aripiprazole
ANDA #203906 |
Aripiprazole | Solution; Oral | SUPPL-15 | Amneal Pharms | Labeling | Approved |
| Aripiprazole
ANDA #212870 |
Aripiprazole | Solution; Oral | SUPPL-6 | Vistapharm Llc | Labeling | Approved |
| Aripiprazole
ANDA #212870 |
Aripiprazole | Solution; Oral | SUPPL-6 | Vistapharm Llc | Labeling | Approved |
| Brexpiprazole
ANDA #213683 |
Brexpiprazole | Tablet; Oral | ORIG-1 | Alembic | Approved | |
| Carbamazepine
ANDA #212524 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Torrent | Approved | |
| Dalvance
NDA #021883 |
Dalbavancin Hydrochloride | Powder; Intravenous | SUPPL-12 | Abbvie | Labeling | Approved |
| Dalvance
NDA #021883 |
Dalbavancin Hydrochloride | Powder; Intravenous | SUPPL-12 | Abbvie | Labeling | Approved |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-14 | Perrigo R and D | Labeling | Approved |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-19 | Perrigo R and D | Labeling | Approved |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-14 | Perrigo R and D | Labeling | Approved |
| Haloperidol
ANDA #075689 |
Haloperidol Lactate | Injectable; Injection | SUPPL-22 | Fresenius Kabi Usa | Labeling | Approved |
| Haloperidol
ANDA #075689 |
Haloperidol Lactate | Injectable; Injection | SUPPL-24 | Fresenius Kabi Usa | Labeling | Approved |
| Haloperidol
ANDA #076035 |
Haloperidol Lactate | Injectable; Injection | SUPPL-26 | Teva Pharms Usa | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208055 |
Lurasidone Hydrochloride | Tablet; Oral | ORIG-2 | Torrent | Approved | |
| Mesna
ANDA #218871 |
Mesna | Tablet; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Regorafenib
ANDA #209728 |
Regorafenib | Tablet; Oral | ORIG-1 | Actavis Labs Fl | Approved | |
| Sacubitril and Valsartan
ANDA #213627 |
Sacubitril; Valsartan | Tablet; Oral | ORIG-1 | Dr Reddys | Approved | |
| Theophylline
ANDA #218401 |
Theophylline | Tablet, Extended Release; Oral | ORIG-1 | Ajanta Pharma Ltd | Approved | |
| Theophylline
ANDA #218401 |
Theophylline | Tablet, Extended Release; Oral | ORIG-2 | Ajanta Pharma Ltd | Tentative Approval | |
| Tretinoin
ANDA #218246 |
Tretinoin | Gel; Topical | ORIG-1 | Aurobindo Pharma Ltd | Approved |
January 17, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acetaminophen and Ibuprofen
ANDA #217241 |
Acetaminophen; Ibuprofen | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Dasatinib
ANDA #217217 |
Dasatinib | Tablet; Oral | ORIG-1 | Biocon Pharma Ltd | Tentative Approval | |
| Datroway
BLA #761394 |
Datopotamab Deruxtecan-Dlnk | Injectable; Iv (Infusion) | ORIG-1 | Daiichi Sankyo Inc | Type 1 - New Molecular Entity | Approved |
| Elelyso
BLA #022458 |
Taliglucerase Alfa | Powder; Intravenous | SUPPL-33 | Pfizer | Labeling | Approved |
January 16, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Artesunate
NDA #213036 |
Artesunate | Powder; Intravenous | SUPPL-8 | Amivas | Labeling | Approved |
| Brynovin
NDA #219122 |
Sitagliptin | Solution; Oral | ORIG-1 | Azurity | Type 3 - New Dosage Form | Approved |
| Calquence
NDA #210259 |
Acalabrutinib | Capsule; Oral | SUPPL-11 | Astrazeneca | Efficacy | Approved |
| Calquence
NDA #216387 |
Acalabrutinib Maleate | Tablet; Oral | SUPPL-5 | Astrazeneca | Efficacy | Approved |
| Carbamazepine
ANDA #219072 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Yichang Humanwell | Approved | |
| Diltiazem Hydrochloride
ANDA #208783 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Novast Labs | Labeling | Approved |
| Diltiazem Hydrochloride
ANDA #208783 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Novast Labs | Labeling | Approved |
| Ephedrine Sulfate
ANDA #218211 |
Ephedrine Sulfate | Solution; Intravenous | ORIG-1 | Gland Pharma Ltd | Approved | |
| Haloperidol
ANDA #078347 |
Haloperidol Lactate | Injectable; Injection | SUPPL-16 | Mylan Labs Ltd | Labeling | Approved |
| Idhifa
NDA #209606 |
Enasidenib Mesylate | Tablet; Oral | SUPPL-7 | Bristol Myers Squibb | Labeling | Approved |
| Levetiracetam In Sodium Chloride
ANDA #219562 |
Levetiracetam | Injectable; Intravenous | ORIG-1 | Caplin | Approved | |
| Linezolid
ANDA #205517 |
Linezolid | Tablet; Oral | SUPPL-14 | Alkem Labs Ltd | Labeling | Approved |
| Lumakras
NDA #214665 |
Sotorasib | Tablet; Oral | SUPPL-9 | Amgen Inc | Efficacy | Approved |
| Naloxone Hydrochloride
ANDA #213843 |
Naloxone Hydrochloride | Injectable; Injection | SUPPL-6 | Mylan Labs Ltd | Labeling | Approved |
| Pantoprazole Sodium
ANDA #219087 |
Pantoprazole Sodium | Tablet, Delayed Release; Oral | ORIG-1 | Graviti Pharms | Approved | |
| Pemetrexed Disodium
NDA #214408 |
Pemetrexed Disodium | Solution; Intravenous | SUPPL-5 | Accord Hlthcare | Labeling | Approved |
| Rifaximin
ANDA #218862 |
Rifaximin | Tablet; Oral | ORIG-1 | Amneal Eu Ltd | Tentative Approval | |
| Sitagliptin; Metformin Hydrochloride
ANDA #214685 |
Sitagliptin;Metformin Hydrochloride | Tablet; Oral | ORIG-1 | Dr Reddys Labs Ltd | Tentative Approval | |
| Ticagrelor
ANDA #211498 |
Ticagrelor | Tablet; Oral | ORIG-1 | Taro Pharm Inds Ltd | Tentative Approval | |
| Vectibix
BLA #125147 |
Panitumumab | Injectable; Iv (Infusion) | SUPPL-213 | Amgen | Efficacy | Approved |
January 15, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Celecoxib
ANDA #208701 |
Celecoxib | Capsule; Oral | SUPPL-3 | Cadila Pharms Ltd | Labeling | Approved |
| Desvenlafaxine Succinate
ANDA #211427 |
Desvenlafaxine Succinate | Tablet, Extended Release; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Dexmethylphenidate Hydrochloride
ANDA #215523 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Ascent Pharms Inc | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #215523 |
Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Ascent Pharms Inc | Labeling | Approved |
| Eptifibatide
ANDA #208554 |
Eptifibatide | Injectable; Injection | SUPPL-4 | Baxter Hlthcare Corp | Labeling | Approved |
| Margenza
BLA #761150 |
Margetuximab-Cmkb | Injectable; Injection | SUPPL-11 | Macrogenics Inc | Labeling | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Injectable; Subcutaneous | SUPPL-3 | Eli Lilly and Co | Efficacy | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Injectable; Subcutaneous | SUPPL-2 | Eli Lilly and Co | Efficacy | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Vial; Single-Use | SUPPL-3 | Eli Lilly and Co | Efficacy | Approved |
| Omvoh
BLA #761279 |
Mirikizumab-Mrkz | Vial; Single-Use | SUPPL-2 | Eli Lilly and Co | Efficacy | Approved |
| Telmisartan
ANDA #203986 |
Telmisartan | Tablet; Oral | ORIG-1 | Macleods Pharms Ltd | Approved | |
| Trifluoperazine Hydrochloride
ANDA #085785 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-84 | Sandoz | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085786 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-92 | Sandoz | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085788 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-87 | Sandoz | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085789 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-88 | Sandoz | Labeling | Approved |
January 14, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Novast Labs | Labeling | Approved |
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Novast Labs | Labeling | Approved |
| Carbamazepine
ANDA #216404 |
Carbamazepine | Tablet, Extended Release; Oral | SUPPL-2 | Novast Labs | Labeling | Approved |
| Carbamazepine
ANDA #217277 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Carbidopa and Levodopa
ANDA #218939 |
Carbidopa; Levodopa | Tablet; Oral | ORIG-1 | Ascent Pharms Inc | Approved | |
| Dimethyl Fumarate
ANDA #210226 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-5 | Lupin | Labeling | Approved |
| Dimethyl Fumarate
ANDA #210226 |
Dimethyl Fumarate | Capsule, Delayed Release; Oral | SUPPL-5 | Lupin | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-25 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-27 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-25 | Aurobindo Pharma Ltd | Labeling | Approved |
| Escitalopram Oxalate
ANDA #079062 |
Escitalopram Oxalate | Solution; Oral | SUPPL-27 | Aurobindo Pharma Ltd | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-12 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-17 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-12 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-17 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-19 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-20 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-22 | Inforlife | Labeling | Approved |
| Fluconazole In Sodium Chloride 0.9% In Plastic Container
ANDA #079104 |
Fluconazole | Injectable; Injection | SUPPL-24 | Inforlife | Labeling | Approved |
| Ipratropium Bromide
ANDA #219222 |
Ipratropium Bromide | Spray, Metered; Nasal | ORIG-1 | Rubicon | Approved | |
| Methotrexate Sodium Preservative Free
ANDA #040716 |
Methotrexate Sodium | Injectable; Injection | SUPPL-16 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040716 |
Methotrexate Sodium | Injectable; Injection | SUPPL-17 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040767 |
Methotrexate Sodium | Injectable; Injection | SUPPL-12 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040767 |
Methotrexate Sodium | Injectable; Injection | SUPPL-13 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040768 |
Methotrexate Sodium | Injectable; Injection | SUPPL-14 | Accord Hlthcare | Labeling | Approved |
| Methotrexate Sodium Preservative Free
ANDA #040768 |
Methotrexate Sodium | Injectable; Injection | SUPPL-15 | Accord Hlthcare | Labeling | Approved |
| Nitrofurantoin
ANDA #208909 |
Nitrofurantoin | Suspension; Oral | ORIG-1 | Appco | Approved | |
| Risperidone
ANDA #076996 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-3 | Actavis Labs Fl Inc | Labeling | Approved |
| Risperidone
ANDA #076996 |
Risperidone | Tablet, Orally Disintegrating; Oral | SUPPL-3 | Actavis Labs Fl Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #079169 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Sun Pharm | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-13 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206381 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-13 | Sciegen Pharms Inc | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-16 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #206465 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-17 | Alkem Labs Ltd | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-7 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-22 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-10 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-3 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-7 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-10 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-22 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-3 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-7 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-8 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-10 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-12 | Umedica | Labeling | Approved |
| Rosuvastatin Calcium
ANDA #207626 |
Rosuvastatin Calcium | Tablet; Oral | SUPPL-22 | Umedica | Labeling | Approved |
| Succinylcholine Chloride
ANDA #215022 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-1 | Sagent Pharms Inc | Labeling | Approved |
| Succinylcholine Chloride
ANDA #215022 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-1 | Sagent Pharms Inc | Labeling | Approved |
| Succinylcholine Chloride
ANDA #215022 |
Succinylcholine Chloride | Injectable; Injection | SUPPL-2 | Sagent Pharms Inc | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #040209 |
Trifluoperazine Hydrochloride | Tablet; Oral | SUPPL-21 | Mylan | Labeling | Approved |
| Trifluoperazine Hydrochloride
ANDA #085787 |
Trifluoperazine Hydrochloride | Concentrate; Oral | SUPPL-32 | Chartwell Rx | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208212 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208228 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Vilazodone Hydrochloride
ANDA #208228 |
Vilazodone Hydrochloride | Tablet; Oral | SUPPL-4 | Apotex | Labeling | Approved |
| Zolpidem Tartrate
ANDA #077903 |
Zolpidem Tartrate | Tablet; Oral | SUPPL-34 | Torrent Pharms | Labeling | Approved |
| Zolpidem Tartrate
ANDA #077903 |
Zolpidem Tartrate | Tablet; Oral | SUPPL-34 | Torrent Pharms | Labeling | Approved |
January 13, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aripiprazole
ANDA #202102 |
Aripiprazole | Tablet, Orally Disintegrating; Oral | SUPPL-25 | Alembic | Labeling | Approved |
| Aripiprazole
ANDA #202102 |
Aripiprazole | Tablet, Orally Disintegrating; Oral | SUPPL-25 | Alembic | Labeling | Approved |
| Aripiprazole
ANDA #203906 |
Aripiprazole | Solution; Oral | SUPPL-15 | Amneal Pharms | Labeling | Approved |
| Aripiprazole
ANDA #203906 |
Aripiprazole | Solution; Oral | SUPPL-15 | Amneal Pharms | Labeling | Approved |
| Aripiprazole
ANDA #212870 |
Aripiprazole | Solution; Oral | SUPPL-6 | Vistapharm Llc | Labeling | Approved |
| Aripiprazole
ANDA #212870 |
Aripiprazole | Solution; Oral | SUPPL-6 | Vistapharm Llc | Labeling | Approved |
| Brexpiprazole
ANDA #213683 |
Brexpiprazole | Tablet; Oral | ORIG-1 | Alembic | Approved | |
| Carbamazepine
ANDA #212524 |
Carbamazepine | Tablet, Extended Release; Oral | ORIG-1 | Torrent | Approved | |
| Dalvance
NDA #021883 |
Dalbavancin Hydrochloride | Powder; Intravenous | SUPPL-12 | Abbvie | Labeling | Approved |
| Dalvance
NDA #021883 |
Dalbavancin Hydrochloride | Powder; Intravenous | SUPPL-12 | Abbvie | Labeling | Approved |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-14 | Perrigo R and D | Labeling | Approved |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-19 | Perrigo R and D | Labeling | Approved |
| Guaifenesin
ANDA #078912 |
Guaifenesin | Tablet, Extended Release; Oral | SUPPL-14 | Perrigo R and D | Labeling | Approved |
| Haloperidol
ANDA #075689 |
Haloperidol Lactate | Injectable; Injection | SUPPL-22 | Fresenius Kabi Usa | Labeling | Approved |
| Haloperidol
ANDA #075689 |
Haloperidol Lactate | Injectable; Injection | SUPPL-24 | Fresenius Kabi Usa | Labeling | Approved |
| Haloperidol
ANDA #076035 |
Haloperidol Lactate | Injectable; Injection | SUPPL-26 | Teva Pharms Usa | Labeling | Approved |
| Lurasidone Hydrochloride
ANDA #208055 |
Lurasidone Hydrochloride | Tablet; Oral | ORIG-2 | Torrent | Approved | |
| Mesna
ANDA #218871 |
Mesna | Tablet; Oral | ORIG-1 | Riconpharma Llc | Approved | |
| Regorafenib
ANDA #209728 |
Regorafenib | Tablet; Oral | ORIG-1 | Actavis Labs Fl | Approved | |
| Sacubitril and Valsartan
ANDA #213627 |
Sacubitril; Valsartan | Tablet; Oral | ORIG-1 | Dr Reddys | Approved | |
| Theophylline
ANDA #218401 |
Theophylline | Tablet, Extended Release; Oral | ORIG-1 | Ajanta Pharma Ltd | Approved | |
| Theophylline
ANDA #218401 |
Theophylline | Tablet, Extended Release; Oral | ORIG-2 | Ajanta Pharma Ltd | Tentative Approval | |
| Tretinoin
ANDA #218246 |
Tretinoin | Gel; Topical | ORIG-1 | Aurobindo Pharma Ltd | Approved |
January 10, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Atorvastatin Calcium
ANDA #216436 |
Atorvastatin Calcium | Tablet; Oral | SUPPL-4 | Biocon Pharma | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #090325 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-20 | Aurobindo Pharma Usa | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #090325 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-21 | Aurobindo Pharma Usa | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #090325 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-20 | Aurobindo Pharma Usa | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #090325 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-21 | Aurobindo Pharma Usa | Labeling | Approved |
| Cyanocobalamin
ANDA #214390 |
Cyanocobalamin | Injectable; Injection | SUPPL-3 | Gland Pharma Ltd | Labeling | Approved |
| Everolimus
ANDA #218863 |
Everolimus | Tablet, For Suspension; Oral | ORIG-1 | Amneal | Approved | |
| Flonase Allergy Relief
NDA #205434 |
Fluticasone Propionate | Spray, Metered; Nasal | SUPPL-17 | Haleon Us Holdings | Labeling | Approved |
| Flonase Sensimist Allergy Relief
NDA #022051 |
Fluticasone Furoate | Spray, Metered; Nasal | SUPPL-24 | Haleon Us Holdings | Labeling | Approved |
| Ibsrela
NDA #211801 |
Tenapanor Hydrochloride | Tablet; Oral | SUPPL-12 | Ardelyx Inc | Labeling | Approved |
| Posluma
NDA #216023 |
Flotufolastat F-18 Gallium | Solution; Intravenous | SUPPL-4 | Blue Earth | Manufacturing (CMC) | Approved |
| Veklury
NDA #214787 |
Remdesivir | Powder; Intravenous | SUPPL-30 | Gilead Sciences Inc | Labeling | Approved |
| Veklury
NDA #214787 |
Remdesivir | Solution; Intravenous | SUPPL-30 | Gilead Sciences Inc | Labeling | Approved |
January 8, 2025
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Advil Liqui-Gels
NDA #020402 |
Ibuprofen | Capsule; Oral | SUPPL-58 | Haleon Us Holdings | Labeling | Approved |
| Advil Migraine Liqui-Gels
NDA #020402 |
Ibuprofen | Capsule; Oral | SUPPL-58 | Haleon Us Holdings | Labeling | Approved |
| Eluryng
ANDA #210830 |
Ethinyl Estradiol; Etonogestrel | Ring; Vaginal | SUPPL-20 | Amneal | Labeling | Approved |
| Eluryng
ANDA #210830 |
Ethinyl Estradiol; Etonogestrel | Ring; Vaginal | SUPPL-20 | Amneal | Labeling | Approved |
| Esomeprazole Sodium
ANDA #214046 |
Esomeprazole Sodium | Injectable; Intravenous | ORIG-1 | Yangtze | Approved | |
| Haloette
ANDA #211328 |
Ethinyl Estradiol; Etonogestrel | Ring; Vaginal | SUPPL-1 | Dr Reddys Labs Sa | Labeling | Approved |
| Imatinib Mesylate
ANDA #208429 |
Imatinib Mesylate | Tablet; Oral | SUPPL-2 | Chartwell Rx | Labeling | Approved |
| Imatinib Mesylate
ANDA #208429 |
Imatinib Mesylate | Tablet; Oral | SUPPL-2 | Chartwell Rx | Labeling | Approved |
| Isosorbide Dinitrate
ANDA #086923 |
Isosorbide Dinitrate | Tablet; Oral | SUPPL-39 | Endo Operations | Labeling | Approved |
| Isosorbide Dinitrate
ANDA #086925 |
Isosorbide Dinitrate | Tablet; Oral | SUPPL-41 | Endo Operations | Labeling | Approved |
| Isosorbide Dinitrate
ANDA #087537 |
Isosorbide Dinitrate | Tablet; Oral | SUPPL-24 | Endo Operations | Labeling | Approved |
| Isosorbide Dinitrate
ANDA #087946 |
Isosorbide Dinitrate | Tablet; Oral | SUPPL-22 | Endo Operations | Labeling | Approved |
| Ivacaftor
ANDA #217431 |
Ivacaftor | Granule; Oral | ORIG-1 | Lupin Ltd | Tentative Approval | |
| Lamotrigine
ANDA #207763 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Lamotrigine
ANDA #207763 |
Lamotrigine | Tablet, Extended Release; Oral | SUPPL-4 | Zydus Pharms | Labeling | Approved |
| Loteprednol Etabonate
ANDA #218087 |
Loteprednol Etabonate | Gel; Ophthalmic | ORIG-1 | Lupin Ltd | Tentative Approval | |
| Methylin
NDA #021475 |
Methylphenidate Hydrochloride | Tablet, Chewable; Oral | SUPPL-13 | Specgx Llc | Labeling | Approved |
| Methylin
NDA #021475 |
Methylphenidate Hydrochloride | Tablet, Chewable; Oral | SUPPL-13 | Specgx Llc | Labeling | Approved |
| Metoprolol Tartrate and Hydrochlorothiazide
ANDA #215789 |
Hydrochlorothiazide; Metoprolol Tartrate | Tablet; Oral | ORIG-1 | Senores Pharms | Approved | |
| Oxcarbazepine
ANDA #218442 |
Oxcarbazepine | Tablet; Extended Release | ORIG-1 | Biocon Pharma Ltd | Tentative Approval | |
| Perampanel
ANDA #218178 |
Perampanel | Tablet; Oral | ORIG-1 | Msn Laboratories Private Ltd | Tentative Approval | |
| Sacubitril and Valsartan
ANDA #213808 |
Sacubitril; Valsartan | Tablet; Oral | ORIG-1 | Lupin | Approved | |
| Tazarotene
ANDA #208662 |
Tazarotene | Cream; Topical | SUPPL-7 | Cosette | Manufacturing (CMC) | Tentative Approval |
| Tazarotene
ANDA #208662 |
Tazarotene | Cream; Topical | SUPPL-7 | Cosette | Manufacturing (CMC) | Tentative Approval |
| Tipiracil Hydrochloride and Trifluridine
ANDA #214024 |
Tipiracil Hydrochloride; Trifluridine | Tablet; Oral | ORIG-1 | Msn | Approved |