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.
April 2, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Balversa
NDA #212018 |
Erdafitinib | Tablet; Oral | SUPPL-1 | Janssen Biotech | Labeling | Approved |
| Gralise
NDA #022544 |
Gabapentin | Tablet; Oral | SUPPL-26 | Almatica | Labeling | Approved |
| Hemangeol
NDA #205410 |
Propranolol Hydrochloride | Solution; Oral | SUPPL-5 | Pierre Fabre Derma | Labeling | Approved |
| Horizant
NDA #022399 |
Gabapentin Enacarbil | Tablet, Extended Release; Oral | SUPPL-11 | Arbor Pharms Llc | Labeling | Approved |
| Neurontin
NDA #020235 |
Gabapentin | Capsule; Oral | SUPPL-68 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #020235 |
Gabapentin | Capsule; Oral | SUPPL-68 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #020882 |
Gabapentin | Tablet; Oral | SUPPL-49 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #020882 |
Gabapentin | Tablet; Oral | SUPPL-49 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #021129 |
Gabapentin | Solution; Oral | SUPPL-49 | Parke Davis | Labeling | Approved |
| Neurontin
NDA #021129 |
Gabapentin | Solution; Oral | SUPPL-49 | Parke Davis | Labeling | Approved |
| Nexavar
NDA #021923 |
Sorafenib Tosylate | Tablet; Oral | SUPPL-23 | Bayer Hlthcare | Labeling | Approved |
| Ropinirole Hydrochloride
ANDA #079165 |
Ropinirole Hydrochloride | Tablet; Oral | SUPPL-4 | Mlv | Labeling | Approved |
| Ropinirole Hydrochloride
ANDA #079165 |
Ropinirole Hydrochloride | Tablet; Oral | SUPPL-5 | Mlv | Labeling | Approved |
| Travatan Z
NDA #021994 |
Travoprost | Solution/Drops; Ophthalmic | SUPPL-13 | Novartis | Labeling | Approved |
April 1, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aloxi
NDA #021372 |
Palonosetron Hydrochloride | Injectable; Intravenous | SUPPL-21 | Helsinn Hlthcare | Labeling | Approved |
| Aloxi
NDA #022233 |
Palonosetron Hydrochloride | Capsule; Oral | SUPPL-6 | Helsinn Hlthcare | Labeling | Approved |
| Azithromycin
ANDA #209044 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Azithromycin
ANDA #209044 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Azithromycin
ANDA #209045 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Azithromycin
ANDA #209045 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Diclofenac Sodium
ANDA #211253 |
Diclofenac Sodium | Gel; Topical | SUPPL-5 | Perrigo Uk Finco | Labeling | Approved |
| Diclofenac Sodium
ANDA #211253 |
Diclofenac Sodium | Gel; Topical | SUPPL-5 | Perrigo Uk Finco | Labeling | Approved |
| Esomeprazole Sodium
ANDA #203349 |
Esomeprazole Sodium | Injectable; Intravenous | ORIG-1 | Gland Pharma Ltd | Approved | |
| Ethosuximide
ANDA #040430 |
Ethosuximide | Capsule; Oral | SUPPL-13 | Bionpharma Inc | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040104 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-25 | Sandoz | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040133 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-29 | Watson Labs | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040133 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-29 | Watson Labs | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040133 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-30 | Watson Labs | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040150 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-7 | Invatech | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040274 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-13 | Mylan | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040760 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-6 | Hikma Pharms | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-1 | Laurus Labs Ltd | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-1 | Laurus Labs Ltd | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-5 | Laurus Labs Ltd | Labeling | Approved |
| Lamotrigine
ANDA #207763 |
Lamotrigine | Tablet, Extended Release; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Montelukast Sodium
ANDA #078605 |
Montelukast Sodium | Tablet; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Montelukast Sodium
ANDA #078605 |
Montelukast Sodium | Tablet; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Montelukast Sodium
ANDA #078723 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Montelukast Sodium
ANDA #078723 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
March 31, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carfilzomib
ANDA #210823 |
Carfilzomib | Unknown | ORIG-1 | Eugia Pharma | Tentative Approval | |
| Cinacalcet Hydrochloride
ANDA #203422 |
Cinacalcet Hydrochloride | Tablet; Oral | SUPPL-1 | Mylan | Labeling | Approved |
| Cinacalcet Hydrochloride
ANDA #203422 |
Cinacalcet Hydrochloride | Tablet; Oral | SUPPL-1 | Mylan | Labeling | Approved |
| Doxycycline Hyclate
ANDA #212610 |
Doxycycline Hyclate | Capsule; Oral | ORIG-1 | Zhejiang Yongtai | Approved | |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-30 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-25 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-30 | Takeda Pharms Usa | Labeling | Approved |
| Ferrlecit
NDA #020955 |
Sodium Ferric Gluconate Complex | Injectable; Injection | SUPPL-17 | Sanofi Aventis Us | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040766 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-13 | Ipca Labs Ltd | Labeling | Approved |
| Metoprolol Succinate
ANDA #203028 |
Metoprolol Succinate | Tablet, Extended Release; Oral | ORIG-1 | Pharmadax Inc | Approved | |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-8 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-9 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-10 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-11 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-12 | Lupin Pharms | Labeling | Approved |
| Voriconazole
ANDA #211099 |
Voriconazole | Injectable; Intravenous | ORIG-1 | Gland Pharma Ltd | Approved |
March 30, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alora
NDA #020655 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-19 | Allergan | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205601 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | ORIG-1 | Rhodes Pharms | Approved | |
| Carboplatin
ANDA #077432 |
Carboplatin | Injectable; Intravenous | SUPPL-8 | Fresenius Kabi Usa | Labeling | Approved |
| Colchicine
ANDA #209876 |
Colchicine | Tablet; Oral | SUPPL-1 | Dr Reddys | Manufacturing (CMC) | Approved |
| Deferasirox
ANDA #210555 |
Deferasirox | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Entacapone
ANDA #202394 |
Entacapone | Tablet; Oral | SUPPL-2 | Mylan Pharms Inc | Labeling | Approved |
| Entacapone
ANDA #203437 |
Entacapone | Tablet; Oral | SUPPL-4 | Aurobindo Pharma Ltd | Labeling | Approved |
| Glyxambi
NDA #206073 |
Empagliflozin; Linagliptin | Tablet; Oral | SUPPL-21 | Boehringer Ingelheim | Efficacy | Approved |
| Jentadueto
NDA #201281 |
Linagliptin; Metformin Hydrochloride | Tablet; Oral | SUPPL-24 | Boehringer Ingelheim | Efficacy | Approved |
| Jentadueto Xr
NDA #208026 |
Linagliptin; Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-12 | Boehringer Ingelheim | Efficacy | Approved |
| Levonorgestrel and Ethinyl Estradiol
NDA #209405 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral | ORIG-1 | Exeltis Usa Inc | Type 3 - New Dosage Form | Approved |
| Methylphenidate Hydrochloride
ANDA #211647 |
Methylphenidate Hydrochloride | Solution; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Metoprolol Succinate
ANDA #203699 |
Metoprolol Succinate | Tablet, Extended Release; Oral | ORIG-1 | Pharmadax Inc | Approved | |
| Moxifloxacin Hydrochloride
ANDA #206447 |
Moxifloxacin Hydrochloride | Solution/Drops; Ophthalmic | ORIG-1 | Mylan | Approved | |
| Moxifloxacin Hydrochloride
ANDA #208778 |
Moxifloxacin Hydrochloride | Solution/Drops; Ophthalmic | ORIG-1 | Gland Pharma Ltd | Approved | |
| Roflumilast
ANDA #208247 |
Roflumilast | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Tradjenta
NDA #201280 |
Linagliptin | Tablet; Oral | SUPPL-20 | Boehringer Ingelheim | Efficacy | Approved |
| Verdeso
NDA #021978 |
Desonide | Aerosol, Foam; Topical | SUPPL-16 | Almirall | Labeling | Approved |
| Verzenio
NDA #208716 |
Abemaciclib | Tablet; Oral | SUPPL-4 | Eli Lilly and Co | Efficacy | Approved |
March 27, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Avonex
BLA #103628 |
Interferon Beta-1a | Vial | SUPPL-5263 | Biogen | Efficacy | Approved |
| Azathioprine
ANDA #208687 |
Azathioprine | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Brineura
BLA #761052 |
Cerliponase Alfa | Injectable; Injection | SUPPL-8 | Biomarin Pharm | Labeling | Approved |
| Gazyva
BLA #125486 |
Obinutuzumab | Injectable; Injection | SUPPL-25 | Genentech | Efficacy | Approved |
| Imfinzi
BLA #761069 |
Durvalumab | Injectable; Injection | SUPPL-18 | Astrazeneca Uk Ltd | Efficacy | Approved |
| Levothyroxine Sodium
ANDA #208837 |
Levothyroxine Sodium | Powder; Intravenous | ORIG-1 | Dr Reddys | Approved | |
| Moxifloxacin Hydrochloride
NDA #205572 |
Moxifloxacin Hydrochloride | Solution; Intravenous | SUPPL-7 | Fresenius Kabi Usa | Labeling | Approved |
| Plegridy
BLA #125499 |
Peginterferon Beta-1a | Injectable; Injection | SUPPL-18 | Biogen Idec Inc | Efficacy | Approved |
| Seroquel
NDA #020639 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-68 | Astrazeneca Pharms | Labeling | Approved |
| Seroquel
NDA #020639 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-68 | Astrazeneca Pharms | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-42 | Astrazeneca | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-42 | Astrazeneca | Labeling | Approved |
| Triferic
NDA #212860 |
Ferric Pyrophosphate Citrate | Solution; Intravenous | ORIG-1 | Rockwell Medical Inc | Type 3 - New Dosage Form | Approved |
| Verapamil Hydrochloride
ANDA #206173 |
Verapamil Hydrochloride | Tablet, Extended Release; Oral | SUPPL-3 | Cadila Pharms Ltd | Labeling | Approved |
March 26, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cardizem Cd
NDA #020062 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-46 | Bausch | Labeling | Approved |
| Cardizem Cd
NDA #020062 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-46 | Bausch | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090610 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090610 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090610 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-5 | Ipca Labs Ltd | Labeling | Approved |
| Taltz
BLA #125521 |
Ixekizumab | Injectable; Injection | SUPPL-20 | Eli Lilly and Co | Efficacy | Approved |
April 2, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Balversa
NDA #212018 |
Erdafitinib | Tablet; Oral | SUPPL-1 | Janssen Biotech | Labeling | Approved |
| Gralise
NDA #022544 |
Gabapentin | Tablet; Oral | SUPPL-26 | Almatica | Labeling | Approved |
| Hemangeol
NDA #205410 |
Propranolol Hydrochloride | Solution; Oral | SUPPL-5 | Pierre Fabre Derma | Labeling | Approved |
| Horizant
NDA #022399 |
Gabapentin Enacarbil | Tablet, Extended Release; Oral | SUPPL-11 | Arbor Pharms Llc | Labeling | Approved |
| Neurontin
NDA #020235 |
Gabapentin | Capsule; Oral | SUPPL-68 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #020235 |
Gabapentin | Capsule; Oral | SUPPL-68 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #020882 |
Gabapentin | Tablet; Oral | SUPPL-49 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #020882 |
Gabapentin | Tablet; Oral | SUPPL-49 | Pfizer Pharms | Labeling | Approved |
| Neurontin
NDA #021129 |
Gabapentin | Solution; Oral | SUPPL-49 | Parke Davis | Labeling | Approved |
| Neurontin
NDA #021129 |
Gabapentin | Solution; Oral | SUPPL-49 | Parke Davis | Labeling | Approved |
| Nexavar
NDA #021923 |
Sorafenib Tosylate | Tablet; Oral | SUPPL-23 | Bayer Hlthcare | Labeling | Approved |
| Ropinirole Hydrochloride
ANDA #079165 |
Ropinirole Hydrochloride | Tablet; Oral | SUPPL-4 | Mlv | Labeling | Approved |
| Ropinirole Hydrochloride
ANDA #079165 |
Ropinirole Hydrochloride | Tablet; Oral | SUPPL-5 | Mlv | Labeling | Approved |
| Travatan Z
NDA #021994 |
Travoprost | Solution/Drops; Ophthalmic | SUPPL-13 | Novartis | Labeling | Approved |
April 1, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Aloxi
NDA #021372 |
Palonosetron Hydrochloride | Injectable; Intravenous | SUPPL-21 | Helsinn Hlthcare | Labeling | Approved |
| Aloxi
NDA #022233 |
Palonosetron Hydrochloride | Capsule; Oral | SUPPL-6 | Helsinn Hlthcare | Labeling | Approved |
| Azithromycin
ANDA #209044 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Azithromycin
ANDA #209044 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Azithromycin
ANDA #209045 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Azithromycin
ANDA #209045 |
Azithromycin | Tablet; Oral | SUPPL-7 | Sunshine Lake | Manufacturing (CMC) | Approved |
| Diclofenac Sodium
ANDA #211253 |
Diclofenac Sodium | Gel; Topical | SUPPL-5 | Perrigo Uk Finco | Labeling | Approved |
| Diclofenac Sodium
ANDA #211253 |
Diclofenac Sodium | Gel; Topical | SUPPL-5 | Perrigo Uk Finco | Labeling | Approved |
| Esomeprazole Sodium
ANDA #203349 |
Esomeprazole Sodium | Injectable; Intravenous | ORIG-1 | Gland Pharma Ltd | Approved | |
| Ethosuximide
ANDA #040430 |
Ethosuximide | Capsule; Oral | SUPPL-13 | Bionpharma Inc | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040104 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-25 | Sandoz | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040133 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-29 | Watson Labs | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040133 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-29 | Watson Labs | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040133 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-30 | Watson Labs | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040150 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-7 | Invatech | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040274 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-13 | Mylan | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040760 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-6 | Hikma Pharms | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-1 | Laurus Labs Ltd | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-1 | Laurus Labs Ltd | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #210959 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-5 | Laurus Labs Ltd | Labeling | Approved |
| Lamotrigine
ANDA #207763 |
Lamotrigine | Tablet, Extended Release; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Montelukast Sodium
ANDA #078605 |
Montelukast Sodium | Tablet; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Montelukast Sodium
ANDA #078605 |
Montelukast Sodium | Tablet; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Montelukast Sodium
ANDA #078723 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
| Montelukast Sodium
ANDA #078723 |
Montelukast Sodium | Tablet, Chewable; Oral | SUPPL-12 | Teva Pharms | Labeling | Approved |
March 31, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Carfilzomib
ANDA #210823 |
Carfilzomib | Unknown | ORIG-1 | Eugia Pharma | Tentative Approval | |
| Cinacalcet Hydrochloride
ANDA #203422 |
Cinacalcet Hydrochloride | Tablet; Oral | SUPPL-1 | Mylan | Labeling | Approved |
| Cinacalcet Hydrochloride
ANDA #203422 |
Cinacalcet Hydrochloride | Tablet; Oral | SUPPL-1 | Mylan | Labeling | Approved |
| Doxycycline Hyclate
ANDA #212610 |
Doxycycline Hyclate | Capsule; Oral | ORIG-1 | Zhejiang Yongtai | Approved | |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-30 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-25 | Takeda Pharms Usa | Labeling | Approved |
| Entyvio
BLA #125476 |
Vedolizumab | Injectable; Injection | SUPPL-30 | Takeda Pharms Usa | Labeling | Approved |
| Ferrlecit
NDA #020955 |
Sodium Ferric Gluconate Complex | Injectable; Injection | SUPPL-17 | Sanofi Aventis Us | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040766 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-13 | Ipca Labs Ltd | Labeling | Approved |
| Metoprolol Succinate
ANDA #203028 |
Metoprolol Succinate | Tablet, Extended Release; Oral | ORIG-1 | Pharmadax Inc | Approved | |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-8 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-9 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-10 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-11 | Lupin Pharms | Labeling | Approved |
| Rifampin
ANDA #090034 |
Rifampin | Capsule; Oral | SUPPL-12 | Lupin Pharms | Labeling | Approved |
| Voriconazole
ANDA #211099 |
Voriconazole | Injectable; Intravenous | ORIG-1 | Gland Pharma Ltd | Approved |
March 30, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Alora
NDA #020655 |
Estradiol | Film, Extended Release; Transdermal | SUPPL-19 | Allergan | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-4 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Bekyree
ANDA #202226 |
Desogestrel; Ethinyl Estradiol | Tablet; Oral-28 | SUPPL-7 | Lupin Ltd | Labeling | Approved |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #205601 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride | Tablet; Sublingual | ORIG-1 | Rhodes Pharms | Approved | |
| Carboplatin
ANDA #077432 |
Carboplatin | Injectable; Intravenous | SUPPL-8 | Fresenius Kabi Usa | Labeling | Approved |
| Colchicine
ANDA #209876 |
Colchicine | Tablet; Oral | SUPPL-1 | Dr Reddys | Manufacturing (CMC) | Approved |
| Deferasirox
ANDA #210555 |
Deferasirox | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Entacapone
ANDA #202394 |
Entacapone | Tablet; Oral | SUPPL-2 | Mylan Pharms Inc | Labeling | Approved |
| Entacapone
ANDA #203437 |
Entacapone | Tablet; Oral | SUPPL-4 | Aurobindo Pharma Ltd | Labeling | Approved |
| Glyxambi
NDA #206073 |
Empagliflozin; Linagliptin | Tablet; Oral | SUPPL-21 | Boehringer Ingelheim | Efficacy | Approved |
| Jentadueto
NDA #201281 |
Linagliptin; Metformin Hydrochloride | Tablet; Oral | SUPPL-24 | Boehringer Ingelheim | Efficacy | Approved |
| Jentadueto Xr
NDA #208026 |
Linagliptin; Metformin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-12 | Boehringer Ingelheim | Efficacy | Approved |
| Levonorgestrel and Ethinyl Estradiol
NDA #209405 |
Ethinyl Estradiol; Levonorgestrel | Tablet; Oral | ORIG-1 | Exeltis Usa Inc | Type 3 - New Dosage Form | Approved |
| Methylphenidate Hydrochloride
ANDA #211647 |
Methylphenidate Hydrochloride | Solution; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Metoprolol Succinate
ANDA #203699 |
Metoprolol Succinate | Tablet, Extended Release; Oral | ORIG-1 | Pharmadax Inc | Approved | |
| Moxifloxacin Hydrochloride
ANDA #206447 |
Moxifloxacin Hydrochloride | Solution/Drops; Ophthalmic | ORIG-1 | Mylan | Approved | |
| Moxifloxacin Hydrochloride
ANDA #208778 |
Moxifloxacin Hydrochloride | Solution/Drops; Ophthalmic | ORIG-1 | Gland Pharma Ltd | Approved | |
| Roflumilast
ANDA #208247 |
Roflumilast | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Tradjenta
NDA #201280 |
Linagliptin | Tablet; Oral | SUPPL-20 | Boehringer Ingelheim | Efficacy | Approved |
| Verdeso
NDA #021978 |
Desonide | Aerosol, Foam; Topical | SUPPL-16 | Almirall | Labeling | Approved |
| Verzenio
NDA #208716 |
Abemaciclib | Tablet; Oral | SUPPL-4 | Eli Lilly and Co | Efficacy | Approved |
March 27, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Avonex
BLA #103628 |
Interferon Beta-1a | Vial | SUPPL-5263 | Biogen | Efficacy | Approved |
| Azathioprine
ANDA #208687 |
Azathioprine | Tablet; Oral | ORIG-1 | Alkem Labs Ltd | Approved | |
| Brineura
BLA #761052 |
Cerliponase Alfa | Injectable; Injection | SUPPL-8 | Biomarin Pharm | Labeling | Approved |
| Gazyva
BLA #125486 |
Obinutuzumab | Injectable; Injection | SUPPL-25 | Genentech | Efficacy | Approved |
| Imfinzi
BLA #761069 |
Durvalumab | Injectable; Injection | SUPPL-18 | Astrazeneca Uk Ltd | Efficacy | Approved |
| Levothyroxine Sodium
ANDA #208837 |
Levothyroxine Sodium | Powder; Intravenous | ORIG-1 | Dr Reddys | Approved | |
| Moxifloxacin Hydrochloride
NDA #205572 |
Moxifloxacin Hydrochloride | Solution; Intravenous | SUPPL-7 | Fresenius Kabi Usa | Labeling | Approved |
| Plegridy
BLA #125499 |
Peginterferon Beta-1a | Injectable; Injection | SUPPL-18 | Biogen Idec Inc | Efficacy | Approved |
| Seroquel
NDA #020639 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-68 | Astrazeneca Pharms | Labeling | Approved |
| Seroquel
NDA #020639 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-68 | Astrazeneca Pharms | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-42 | Astrazeneca | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-42 | Astrazeneca | Labeling | Approved |
| Triferic
NDA #212860 |
Ferric Pyrophosphate Citrate | Solution; Intravenous | ORIG-1 | Rockwell Medical Inc | Type 3 - New Dosage Form | Approved |
| Verapamil Hydrochloride
ANDA #206173 |
Verapamil Hydrochloride | Tablet, Extended Release; Oral | SUPPL-3 | Cadila Pharms Ltd | Labeling | Approved |
March 26, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cardizem Cd
NDA #020062 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-46 | Bausch | Labeling | Approved |
| Cardizem Cd
NDA #020062 |
Diltiazem Hydrochloride | Capsule, Extended Release; Oral | SUPPL-46 | Bausch | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090610 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090610 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090610 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-5 | Ipca Labs Ltd | Labeling | Approved |
| Taltz
BLA #125521 |
Ixekizumab | Injectable; Injection | SUPPL-20 | Eli Lilly and Co | Efficacy | Approved |
March 25, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Datscan
NDA #022454 |
Ioflupane I-123 | Solution; Intravenous | SUPPL-7 | Ge Hlthcare Inc | Labeling | Approved |
| Dorzolamide Hydrochloride
ANDA #078981 |
Dorzolamide Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-5 | Sandoz Inc | Labeling | Approved |
| Dorzolamide Hydrochloride
ANDA #079186 |
Dorzolamide Hydrochloride | Solution/Drops; Ophthalmic | SUPPL-3 | Am Regent | Labeling | Approved |
| Gabapentin
ANDA #090858 |
Gabapentin | Capsule; Oral | SUPPL-13 | Alkem | Labeling | Approved |
| Gabapentin
ANDA #090858 |
Gabapentin | Capsule; Oral | SUPPL-17 | Alkem | Labeling | Approved |
| Guaifenesin and Pseudoephedrine Hydrochloride
ANDA #213203 |
Guaifenesin; Pseudoephedrine Hydrochloride | Tablet, Extended Release; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Lidocaine Hydrochloride
ANDA #040433 |
Lidocaine Hydrochloride | Jelly; Topical | SUPPL-14 | Akorn | Labeling | Approved |
| Omeprazole Magnesium
ANDA #211732 |
Omeprazole Magnesium | Tablet, Delayed Release; Oral | ORIG-1 | Hetero Labs Ltd Iii | Approved | |
| Pregabalin
ANDA #211889 |
Pregabalin | Unknown | ORIG-1 | Sun Pharm Inds Ltd | Tentative Approval | |
| Saxenda
NDA #206321 |
Liraglutide Recombinant | Solution; Subcutaneous | SUPPL-11 | Novo | Efficacy | Approved |
| Sevelamer Carbonate
ANDA #207624 |
Sevelamer Carbonate | For Suspension; Oral | SUPPL-1 | Aurobindo Pharma Ltd | Labeling | Approved |
| Sevelamer Carbonate
ANDA #207624 |
Sevelamer Carbonate | For Suspension; Oral | SUPPL-1 | Aurobindo Pharma Ltd | Labeling | Approved |
| Sojourn
ANDA #077867 |
Sevoflurane | Liquid; Inhalation | SUPPL-18 | Piramal Critical | Labeling | Approved |
| Sumatriptan and Naproxen Sodium
ANDA #090872 |
Naproxen Sodium; Sumatriptan Succinate | Tablet; Oral | SUPPL-1 | Mylan | Labeling | Approved |
| Sumatriptan and Naproxen Sodium
ANDA #090872 |
Naproxen Sodium; Sumatriptan Succinate | Tablet; Oral | SUPPL-1 | Mylan | Labeling | Approved |
| Verapamil Hydrochloride
ANDA #213232 |
Verapamil Hydrochloride | Solution; Intravenous | ORIG-1 | Caplin | Approved | |
| Zeposia
NDA #209899 |
Ozanimod Hydrochloride | Capsule; Oral | ORIG-1 | Celgene | Type 1 - New Molecular Entity | Approved |
March 24, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Chloroquine Phosphate
ANDA #090249 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-3 | Ipca Labs Ltd | Labeling | Approved |
| Chloroquine Phosphate
ANDA #090249 |
Chloroquine Phosphate | Tablet; Oral | SUPPL-4 | Ipca Labs Ltd | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-10 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-13 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-14 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-10 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-11 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-12 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-13 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #076999 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-14 | Teva | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #090307 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-1 | Actavis Totowa | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #090307 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Actavis Totowa | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #090307 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-1 | Actavis Totowa | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #090307 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Actavis Totowa | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-5 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-6 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-6 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-5 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-6 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-7 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #202266 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-7 | Celltrion | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #206376 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #206376 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Prinston Inc | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #206376 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #206376 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Prinston Inc | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #206376 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-1 | Prinston Inc | Labeling | Approved |
| Clopidogrel Bisulfate
ANDA #206376 |
Clopidogrel Bisulfate | Tablet; Oral | SUPPL-2 | Prinston Inc | Labeling | Approved |
| Dexmethylphenidate Hydrochloride
ANDA #209754 |
Dexmethylphenidate Hydrochloride | Tablet; Oral | ORIG-1 | Bionpharma Inc | Approved | |
| Dovato
NDA #211994 |
Dolutegravir Sodium; Lamivudine | Tablet; Oral | SUPPL-4 | Viiv Hlthcare | Labeling | Approved |
| Dovato
NDA #211994 |
Dolutegravir Sodium; Lamivudine | Tablet; Oral | SUPPL-4 | Viiv Hlthcare | Labeling | Approved |
| Lactulose
ANDA #074623 |
Lactulose | Solution; Oral | SUPPL-12 | Pharm Assoc | Labeling | Approved |
| Lactulose
ANDA #074623 |
Lactulose | Solution; Oral | SUPPL-10 | Pharm Assoc | Labeling | Approved |
| Lactulose
ANDA #074623 |
Lactulose | Solution; Oral | SUPPL-11 | Pharm Assoc | Labeling | Approved |
| Lactulose
ANDA #074623 |
Lactulose | Solution; Oral | SUPPL-12 | Pharm Assoc | Labeling | Approved |
| Milrinone Lactate
ANDA #211671 |
Milrinone Lactate | Injectable; Injection | ORIG-1 | Nanjing King-Friend | Approved | |
| Relpax
NDA #021016 |
Eletriptan Hydrobromide | Tablet; Oral | SUPPL-29 | Pfizer Ireland | Labeling | Approved |
| Sernivo
NDA #208079 |
Betamethasone Dipropionate | Spray; Topical | SUPPL-2 | Encore Dermat | Labeling | Approved |
| Tivicay
NDA #204790 |
Dolutegravir Sodium | Tablet; Oral | SUPPL-23 | Viiv Hlthcare | Labeling | Approved |
| Tivicay
NDA #204790 |
Dolutegravir Sodium | Tablet; Oral | SUPPL-23 | Viiv Hlthcare | Labeling | Approved |
| Tizanidine Hydrochloride
ANDA #213544 |
Tizanidine Hydrochloride | Capsule; Oral | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Triumeq
NDA #205551 |
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | Tablet; Oral | SUPPL-21 | Viiv Hlthcare | Labeling | Approved |
| Triumeq
NDA #205551 |
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | Tablet; Oral | SUPPL-21 | Viiv Hlthcare | Labeling | Approved |
March 23, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Cleocin
NDA #050680 |
Clindamycin Phosphate | Cream; Vaginal | SUPPL-18 | Pharmacia and Upjohn | Labeling | Approved |
| Cleocin
NDA #050767 |
Clindamycin Phosphate | Suppository; Vaginal | SUPPL-17 | Pharmacia and Upjohn | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #211751 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Cipla | Approved | |
| Esomeprazole Magnesium
ANDA #211752 |
Esomeprazole Magnesium | For Suspension, Delayed Release; Oral | ORIG-1 | Cipla | Approved | |
| Eucrisa
NDA #207695 |
Crisaborole | Ointment; Topical | SUPPL-10 | Anacor Pharms Inc | Efficacy | Approved |
| Eucrisa
NDA #207695 |
Crisaborole | Ointment; Topical | SUPPL-7 | Anacor Pharms Inc | Labeling | Approved |
| Eucrisa
NDA #207695 |
Crisaborole | Ointment; Topical | SUPPL-9 | Anacor Pharms Inc | Labeling | Approved |
| Hydroxychloroquine Sulfate
ANDA #040657 |
Hydroxychloroquine Sulfate | Tablet; Oral | SUPPL-7 | Zydus Pharms Usa Inc | Labeling | Approved |
| Irbesartan and Hydrochlorothiazide
ANDA #077969 |
Hydrochlorothiazide; Irbesartan | Tablet; Oral | SUPPL-7 | Mylan Pharms Inc | Labeling | Approved |
| Pregabalin
ANDA #213423 |
Pregabalin | Capsule; Oral | ORIG-1 | Hikal | Approved | |
| Prevymis
NDA #209939 |
Letermovir | Tablet; Oral | SUPPL-8 | Merck Sharp Dohme | Labeling | Approved |
| Prevymis
NDA #209940 |
Letermovir | Solution; Intravenous | SUPPL-6 | Merck Sharp Dohme | Labeling | Approved |
| Ranolazine
ANDA #211865 |
Ranolazine | Tablet, Extended Release; Oral | ORIG-1 | Sunshine Lake | Approved | |
| Ranolazine
ANDA #212781 |
Ranolazine | Tablet, Extended Release; Oral | ORIG-1 | Sungen Pharma | Approved |
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