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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