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.

November 26, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Testosterone
ANDA #209181
Testosterone Unknown ORIG-1 Apotex Inc Approved

November 25, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Danyelza
BLA #761171
Naxitamab-Gqgk Solution; Intravenous ORIG-1 Y-Mabs Therapeutics Inc Type 1 - New Molecular Entity Approved
Gefitinib
ANDA #209792
Gefitinib Unknown ORIG-1 Synthon Pharms Tentative Approval
Guanfacine
ANDA #213428
Guanfacine Unknown ORIG-1 Yichang Humanwell Approved
Imcivree
NDA #213793
Setmelanotide Solution; Subcutaneous ORIG-1 Rhythm Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Jynarque
NDA #204441
Tolvaptan Tablet; Oral SUPPL-9 Otsuka Pharm Co Ltd REMS Approved
Micafungin Sodium
NDA #212125
Micafungin Sodium Unknown ORIG-1 Teva Pharms Usa Type 5 - New Formulation or New Manufacturer Tentative Approval
Scopolamine
ANDA #212342
Scopolamine Film, Extended Release; Transdermal ORIG-1 Riconpharma Llc Approved
Succinylcholine Chloride
ANDA #214879
Succinylcholine Chloride Injectable; Injection ORIG-1 Micro Labs Approved
Tavaborole
ANDA #212256
Tavaborole Unknown ORIG-1 Amneal Pharms Llc Approved
Testosterone
ANDA #213922
Testosterone Unknown ORIG-1 Aleor Dermaceuticals Tentative Approval

November 24, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Docetaxel
NDA #022234
Docetaxel Injectable; Injection SUPPL-18 Hospira Inc Labeling Approved
Idhifa
NDA #209606
Enasidenib Mesylate Tablet; Oral SUPPL-4 Celgene Corp Efficacy Approved
Rydapt
NDA #207997
Midostaurin Capsule; Oral SUPPL-6 Novartis Efficacy Approved
Valcyte
NDA #021304
Valganciclovir Hydrochloride Tablet; Oral SUPPL-16 Hoffmann La Roche Labeling Approved
Valcyte
NDA #022257
Valganciclovir Hydrochloride For Solution; Oral SUPPL-11 Hoffmann La Roche Labeling Approved
Ziagen
NDA #020977
Abacavir Sulfate Tablet; Oral SUPPL-35 Viiv Hlthcare Labeling Approved
Ziagen
NDA #020978
Abacavir Sulfate Solution; Oral SUPPL-38 Viiv Hlthcare Labeling Approved

November 23, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bexarotene
ANDA #209861
Bexarotene Capsule; Oral SUPPL-3 Ani Pharms Inc Labeling Approved
Cefazolin and Dextrose
NDA #050779
Cefazolin Sodium Injectable; Injection SUPPL-27 B Braun Efficacy Approved
Cosopt
NDA #020869
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-42 Akorn Labeling Approved
Decitabine
ANDA #205539
Decitabine Injectable; Intravenous ORIG-1 Apotex Approved
Dexmedetomidine Hydrochloride
ANDA #212857
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Tagi Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #206894
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Cipla Labeling Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #206894
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Cipla Labeling Approved
Fusilev
NDA #020140
Levoleucovorin Calcium Powder; Intravenous SUPPL-26 Acrotech Labeling Approved
Fusilev
NDA #020140
Levoleucovorin Calcium Solution; Intravenous SUPPL-26 Acrotech Labeling Approved
Nplate
BLA #125268
Romiplostim Injectable; Subcutaneous SUPPL-169 Amgen Labeling Approved
Nuplazid
NDA #207318
Pimavanserin Tartrate Tablet; Oral SUPPL-10 Acadia Pharms Inc Labeling Approved
Nuplazid
NDA #210793
Pimavanserin Tartrate Capsule; Oral SUPPL-7 Acadia Pharms Inc Labeling Approved
Oxlumo
NDA #214103
Lumasiran Solution; Subcutaneous ORIG-1 Alnylam Pharms Inc Type 1 - New Molecular Entity Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Unknown ORIG-1 Xiamen Lp Pharm Co Tentative Approval
Tadalafil
ANDA #213496
Tadalafil Tablet; Oral ORIG-1 Sunshine Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-10 Genentech Inc Efficacy Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-4 Genentech Inc Efficacy Approved
Xofluza
NDA #214410
Baloxavir Marboxil Suspension; Oral ORIG-1 Genentech Inc Type 3 - New Dosage Form Approved

November 20, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #208327
Abiraterone Acetate Tablet; Oral SUPPL-10 Amneal Pharms Labeling Approved
Abiraterone Acetate
ANDA #208327
Abiraterone Acetate Tablet; Oral SUPPL-10 Amneal Pharms Labeling Approved
Atropen
NDA #017106
Atropine Solution; Intramuscular SUPPL-52 Meridian Medcl Techn Labeling Approved
Atropen
NDA #017106
Atropine Solution; Intramuscular SUPPL-52 Meridian Medcl Techn Labeling Approved
Blenrep
BLA #761158
Belantamab Mafodotin-Blmf Injectable; Intravenous SUPPL-3 Glaxosmithkline REMS Approved
Dextrose 5% In Plastic Container
ANDA #207449
Dextrose Injectable; Injection SUPPL-14 Fresenius Kabi Usa Manufacturing (CMC) Approved
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-4 Janssen Biotech Efficacy Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-10 Dexcel Pharma Labeling Approved
Palynziq
BLA #761079
Pegvaliase-Pqpz Injectable; Injection SUPPL-10 Biomarin Pharm Labeling Approved
Pomalyst
NDA #204026
Pomalidomide Capsule; Oral SUPPL-27 Celgene Efficacy Approved
Prednisone
ANDA #209727
Prednisone Tablet; Oral ORIG-1 Strides Pharma Approved
Sevelamer Carbonate
ANDA #211316
Sevelamer Carbonate For Suspension; Oral ORIG-1 Impax Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-434 Alexion Pharm Labeling Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-434 Alexion Pharm Labeling Approved
Succinylcholine Chloride
ANDA #211346
Succinylcholine Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Temodar
NDA #021029
Temozolomide Capsule; Oral SUPPL-35 Merck Sharp Dohme Labeling Approved
Temodar
NDA #022277
Temozolomide Powder; Intravenous SUPPL-14 Merck Sharp Dohme Labeling Approved
Victoza
NDA #022341
Liraglutide Recombinant Solution; Subcutaneous SUPPL-36 Novo Nordisk Inc Labeling Approved
Victoza
NDA #022341
Liraglutide Recombinant Solution; Subcutaneous SUPPL-36 Novo Nordisk Inc Labeling Approved
Zokinvy
NDA #213969
Ionafarnib Capsule; Oral ORIG-1 Eiger Biopharmaceuticals Inc Type 1 - New Molecular Entity Approved

November 19, 2020

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Canagliflozin; Metformin Hydrochloride
ANDA #210481
Canagliflozin;Metformin Hydrochloride Unknown ORIG-1 Sandoz Inc Tentative Approval
Dolutegravir
NDA #214521
Dolutegravir Tablet; Oral ORIG-1 Mylan Labs Ltd Type 3 - New Dosage Form Tentative Approval
Sodium Chloride 0.9% In Plastic Container
ANDA #207310
Sodium Chloride Injectable; Injection SUPPL-12 Fresenius Kabi Usa Manufacturing (CMC) Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-23 Abbvie Inc Labeling Approved

November 26, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Testosterone
ANDA #209181
Testosterone Unknown ORIG-1 Apotex Inc Approved

November 25, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Danyelza
BLA #761171
Naxitamab-Gqgk Solution; Intravenous ORIG-1 Y-Mabs Therapeutics Inc Type 1 - New Molecular Entity Approved
Gefitinib
ANDA #209792
Gefitinib Unknown ORIG-1 Synthon Pharms Tentative Approval
Guanfacine
ANDA #213428
Guanfacine Unknown ORIG-1 Yichang Humanwell Approved
Imcivree
NDA #213793
Setmelanotide Solution; Subcutaneous ORIG-1 Rhythm Pharmaceuticals Inc Type 1 - New Molecular Entity Approved
Jynarque
NDA #204441
Tolvaptan Tablet; Oral SUPPL-9 Otsuka Pharm Co Ltd REMS Approved
Micafungin Sodium
NDA #212125
Micafungin Sodium Unknown ORIG-1 Teva Pharms Usa Type 5 - New Formulation or New Manufacturer Tentative Approval
Scopolamine
ANDA #212342
Scopolamine Film, Extended Release; Transdermal ORIG-1 Riconpharma Llc Approved
Succinylcholine Chloride
ANDA #214879
Succinylcholine Chloride Injectable; Injection ORIG-1 Micro Labs Approved
Tavaborole
ANDA #212256
Tavaborole Unknown ORIG-1 Amneal Pharms Llc Approved
Testosterone
ANDA #213922
Testosterone Unknown ORIG-1 Aleor Dermaceuticals Tentative Approval

November 24, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Docetaxel
NDA #022234
Docetaxel Injectable; Injection SUPPL-18 Hospira Inc Labeling Approved
Idhifa
NDA #209606
Enasidenib Mesylate Tablet; Oral SUPPL-4 Celgene Corp Efficacy Approved
Rydapt
NDA #207997
Midostaurin Capsule; Oral SUPPL-6 Novartis Efficacy Approved
Valcyte
NDA #021304
Valganciclovir Hydrochloride Tablet; Oral SUPPL-16 Hoffmann La Roche Labeling Approved
Valcyte
NDA #022257
Valganciclovir Hydrochloride For Solution; Oral SUPPL-11 Hoffmann La Roche Labeling Approved
Ziagen
NDA #020977
Abacavir Sulfate Tablet; Oral SUPPL-35 Viiv Hlthcare Labeling Approved
Ziagen
NDA #020978
Abacavir Sulfate Solution; Oral SUPPL-38 Viiv Hlthcare Labeling Approved

November 23, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Bexarotene
ANDA #209861
Bexarotene Capsule; Oral SUPPL-3 Ani Pharms Inc Labeling Approved
Cefazolin and Dextrose
NDA #050779
Cefazolin Sodium Injectable; Injection SUPPL-27 B Braun Efficacy Approved
Cosopt
NDA #020869
Dorzolamide Hydrochloride; Timolol Maleate Solution/Drops; Ophthalmic SUPPL-42 Akorn Labeling Approved
Decitabine
ANDA #205539
Decitabine Injectable; Intravenous ORIG-1 Apotex Approved
Dexmedetomidine Hydrochloride
ANDA #212857
Dexmedetomidine Hydrochloride Injectable; Injection ORIG-1 Tagi Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #206894
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Cipla Labeling Approved
Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
ANDA #206894
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-1 Cipla Labeling Approved
Fusilev
NDA #020140
Levoleucovorin Calcium Powder; Intravenous SUPPL-26 Acrotech Labeling Approved
Fusilev
NDA #020140
Levoleucovorin Calcium Solution; Intravenous SUPPL-26 Acrotech Labeling Approved
Nplate
BLA #125268
Romiplostim Injectable; Subcutaneous SUPPL-169 Amgen Labeling Approved
Nuplazid
NDA #207318
Pimavanserin Tartrate Tablet; Oral SUPPL-10 Acadia Pharms Inc Labeling Approved
Nuplazid
NDA #210793
Pimavanserin Tartrate Capsule; Oral SUPPL-7 Acadia Pharms Inc Labeling Approved
Oxlumo
NDA #214103
Lumasiran Solution; Subcutaneous ORIG-1 Alnylam Pharms Inc Type 1 - New Molecular Entity Approved
Pramipexole Dihydrochloride
ANDA #212797
Pramipexole Dihydrochloride Unknown ORIG-1 Xiamen Lp Pharm Co Tentative Approval
Tadalafil
ANDA #213496
Tadalafil Tablet; Oral ORIG-1 Sunshine Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-10 Genentech Inc Efficacy Approved
Xofluza
NDA #210854
Baloxavir Marboxil Tablet; Oral SUPPL-4 Genentech Inc Efficacy Approved
Xofluza
NDA #214410
Baloxavir Marboxil Suspension; Oral ORIG-1 Genentech Inc Type 3 - New Dosage Form Approved

November 20, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abiraterone Acetate
ANDA #208327
Abiraterone Acetate Tablet; Oral SUPPL-10 Amneal Pharms Labeling Approved
Abiraterone Acetate
ANDA #208327
Abiraterone Acetate Tablet; Oral SUPPL-10 Amneal Pharms Labeling Approved
Atropen
NDA #017106
Atropine Solution; Intramuscular SUPPL-52 Meridian Medcl Techn Labeling Approved
Atropen
NDA #017106
Atropine Solution; Intramuscular SUPPL-52 Meridian Medcl Techn Labeling Approved
Blenrep
BLA #761158
Belantamab Mafodotin-Blmf Injectable; Intravenous SUPPL-3 Glaxosmithkline REMS Approved
Dextrose 5% In Plastic Container
ANDA #207449
Dextrose Injectable; Injection SUPPL-14 Fresenius Kabi Usa Manufacturing (CMC) Approved
Erleada
NDA #210951
Apalutamide Tablet; Oral SUPPL-4 Janssen Biotech Efficacy Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-10 Dexcel Pharma Labeling Approved
Palynziq
BLA #761079
Pegvaliase-Pqpz Injectable; Injection SUPPL-10 Biomarin Pharm Labeling Approved
Pomalyst
NDA #204026
Pomalidomide Capsule; Oral SUPPL-27 Celgene Efficacy Approved
Prednisone
ANDA #209727
Prednisone Tablet; Oral ORIG-1 Strides Pharma Approved
Sevelamer Carbonate
ANDA #211316
Sevelamer Carbonate For Suspension; Oral ORIG-1 Impax Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-434 Alexion Pharm Labeling Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-434 Alexion Pharm Labeling Approved
Succinylcholine Chloride
ANDA #211346
Succinylcholine Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Approved
Temodar
NDA #021029
Temozolomide Capsule; Oral SUPPL-35 Merck Sharp Dohme Labeling Approved
Temodar
NDA #022277
Temozolomide Powder; Intravenous SUPPL-14 Merck Sharp Dohme Labeling Approved
Victoza
NDA #022341
Liraglutide Recombinant Solution; Subcutaneous SUPPL-36 Novo Nordisk Inc Labeling Approved
Victoza
NDA #022341
Liraglutide Recombinant Solution; Subcutaneous SUPPL-36 Novo Nordisk Inc Labeling Approved
Zokinvy
NDA #213969
Ionafarnib Capsule; Oral ORIG-1 Eiger Biopharmaceuticals Inc Type 1 - New Molecular Entity Approved

November 19, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Canagliflozin; Metformin Hydrochloride
ANDA #210481
Canagliflozin;Metformin Hydrochloride Unknown ORIG-1 Sandoz Inc Tentative Approval
Dolutegravir
NDA #214521
Dolutegravir Tablet; Oral ORIG-1 Mylan Labs Ltd Type 3 - New Dosage Form Tentative Approval
Sodium Chloride 0.9% In Plastic Container
ANDA #207310
Sodium Chloride Injectable; Injection SUPPL-12 Fresenius Kabi Usa Manufacturing (CMC) Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-23 Abbvie Inc Labeling Approved

November 18, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cilostazol
ANDA #077022
Cilostazol Tablet; Oral SUPPL-9 Epic Pharma Llc Labeling Approved
Cilostazol
ANDA #077150
Cilostazol Tablet; Oral SUPPL-7 Epic Pharma Llc Labeling Approved
Esomeprazole Magnesium
ANDA #213859
Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral ORIG-1 Amta Approved
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-23 Astrazeneca Uk Ltd Efficacy Approved
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-24 Astrazeneca Uk Ltd Efficacy Approved
Imfinzi
BLA #761069
Durvalumab Injectable; Injection SUPPL-25 Astrazeneca Uk Ltd Labeling Approved
Neulasta
BLA #125031
Pegfilgrastim Syringe SUPPL-201 Amgen Labeling Approved
Neulasta
BLA #125031
Pegfilgrastim Syringe SUPPL-201 Amgen Labeling Approved
Nifedipine
ANDA #212016
Nifedipine Tablet, Extended Release; Oral ORIG-1 Elite Approved
Optiray 240
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 240
NDA #020923
Ioversol Injectable; Injection SUPPL-25 Liebel-Flarsheim Labeling Approved
Optiray 240
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 300
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 300
NDA #020923
Ioversol Injectable; Injection SUPPL-25 Liebel-Flarsheim Labeling Approved
Optiray 300
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 320
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 320
NDA #020923
Ioversol Injectable; Injection SUPPL-25 Liebel-Flarsheim Labeling Approved
Optiray 320
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 350
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Optiray 350
NDA #020923
Ioversol Injectable; Injection SUPPL-25 Liebel-Flarsheim Labeling Approved
Optiray 350
NDA #020923
Ioversol Injectable; Injection SUPPL-26 Liebel-Flarsheim Labeling Approved
Oxaprozin
ANDA #075987
Oxaprozin Tablet; Oral SUPPL-8 Chartwell Labeling Approved
Oxaprozin
ANDA #075987
Oxaprozin Tablet; Oral SUPPL-9 Chartwell Labeling Approved
Oxaprozin
ANDA #075987
Oxaprozin Tablet; Oral SUPPL-9 Chartwell Labeling Approved
Septra
NDA #017376
Sulfamethoxazole; Trimethoprim Tablet; Oral SUPPL-62 Monarch Pharms Labeling Approved
Septra Ds
NDA #017376
Sulfamethoxazole; Trimethoprim Tablet; Oral SUPPL-62 Monarch Pharms Labeling Approved
Tranexamic Acid
ANDA #202755
Tranexamic Acid Injectable; Injection SUPPL-3 Virtus Pharms Labeling Approved
Tranexamic Acid
ANDA #206713
Tranexamic Acid Injectable; Injection SUPPL-3 Micro Labs Labeling Approved
Tranexamic Acid
ANDA #212676
Tranexamic Acid Injectable; Injection SUPPL-1 Apollo Labeling Approved
Trikafta (Copackaged)
NDA #212273
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor Tablet, Tablet; Oral SUPPL-1 Vertex Pharms Inc Labeling Approved
Trokendi Xr
NDA #201635
Topiramate Capsule, Extended Release; Oral SUPPL-25 Supernus Pharms Labeling Approved

November 17, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Calcium Acetate
ANDA #211038
Calcium Acetate Capsule; Oral SUPPL-2 Suven Pharms Labeling Approved
Calcium Acetate
ANDA #211038
Calcium Acetate Capsule; Oral SUPPL-2 Suven Pharms Labeling Approved
Chlordiazepoxide Hcl; Clidinium Bromide
ANDA #214065
Chlordiazepoxide Hcl;Clidinium Bromide Unknown ORIG-1 Alkem Labs Ltd Tentative Approval
Definity
NDA #021064
Perflutren Injectable; Intravenous SUPPL-24 Lantheus Medcl Labeling Approved
Divalproex Sodium
ANDA #211505
Divalproex Sodium Capsule, Delayed Rel Pellets; Oral ORIG-1 Teva Pharms Usa Approved
Entereg
NDA #021775
Alvimopan Capsule; Oral SUPPL-18 Cubist Pharms Labeling Approved
Fulvestrant
ANDA #211689
Fulvestrant Injectable; Intramuscular ORIG-1 Accord Hlthcare Approved
Haldol
NDA #015923
Haloperidol Lactate Injectable; Injection SUPPL-93 Janssen Pharms Labeling Approved
Haldol
NDA #015923
Haloperidol Lactate Injectable; Injection SUPPL-98 Janssen Pharms Labeling Approved
Haldol
NDA #018701
Haloperidol Decanoate Injectable; Injection SUPPL-71 Janssen Pharms Labeling Approved
Haldol
NDA #018701
Haloperidol Decanoate Injectable; Injection SUPPL-76 Janssen Pharms Labeling Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #211487
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Ascent Pharms Inc Manufacturing (CMC) Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #211487
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-5 Ascent Pharms Inc Manufacturing (CMC) Approved
Olmesartan Medoxomil
ANDA #207135
Olmesartan Medoxomil Tablet; Oral SUPPL-1 Umedica Labs Pvt Ltd Labeling Approved
Olmesartan Medoxomil
ANDA #208130
Olmesartan Medoxomil Tablet; Oral SUPPL-5 Sciegen Pharms Inc Labeling Approved
Olmesartan Medoxomil
ANDA #210552
Olmesartan Medoxomil Tablet; Oral SUPPL-1 Qilu Labeling Approved
Risperidone
ANDA #077493
Risperidone Tablet; Oral SUPPL-6 Prinston Inc Labeling Approved
Risperidone
ANDA #077493
Risperidone Tablet; Oral SUPPL-4 Prinston Inc Labeling Approved
Risperidone
ANDA #077493
Risperidone Tablet; Oral SUPPL-6 Prinston Inc Labeling Approved
Risperidone
ANDA #077493
Risperidone Tablet; Oral SUPPL-6 Prinston Inc Labeling Approved
Valacyclovir Hydrochloride
ANDA #077655
Valacyclovir Hydrochloride Tablet; Oral SUPPL-9 Teva Pharms Labeling Approved
Valacyclovir Hydrochloride
ANDA #077655
Valacyclovir Hydrochloride Tablet; Oral SUPPL-9 Teva Pharms Labeling Approved

November 16, 2020

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cilostazol
ANDA #077030
Cilostazol Tablet; Oral SUPPL-7 Apotex Inc Labeling Approved
Cilostazol
ANDA #077030
Cilostazol Tablet; Oral SUPPL-7 Apotex Inc Labeling Approved
Cilostazol
ANDA #077030
Cilostazol Tablet; Oral SUPPL-7 Apotex Inc Labeling Approved
Forteo
NDA #021318
Teriparatide Solution; Subcutaneous SUPPL-54 Lilly Efficacy Approved
Halobetasol Propionate
ANDA #214285
Halobetasol Propionate Unknown ORIG-1 Perrigo Israel Tentative Approval
Krintafel
NDA #210795
Tafenoquine Succinate Tablet; Oral SUPPL-1 Glaxosmithkline Labeling Approved
Lipitor
NDA #020702
Atorvastatin Calcium Tablet; Oral SUPPL-77 Upjohn Labeling Approved
Multaq
NDA #022425
Dronedarone Hydrochloride Tablet; Oral SUPPL-29 Sanofi Aventis Us Labeling Approved
Multaq
NDA #022425
Dronedarone Hydrochloride Tablet; Oral SUPPL-29 Sanofi Aventis Us Labeling Approved
Multaq
NDA #022425
Dronedarone Hydrochloride Tablet; Oral SUPPL-29 Sanofi Aventis Us Labeling Approved
Mytesi
NDA #202292
Crofelemer Tablet, Delayed Release; Oral SUPPL-7 Napo Pharms Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-4 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-6 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-10 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-3 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-4 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-6 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-7 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Barr Labs Inc Labeling Approved
Olanzapine
ANDA #077243
Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-10 Barr Labs Inc Labeling Approved
Omeprazole
ANDA #207891
Omeprazole Tablet, Delayed Release; Oral SUPPL-2 Sun Pharm Labeling Approved
Omeprazole
ANDA #207891
Omeprazole Tablet, Delayed Release; Oral SUPPL-2 Sun Pharm Labeling Approved
Omeprazole
ANDA #207891
Omeprazole Tablet, Delayed Release; Oral SUPPL-2 Sun Pharm Labeling Approved
Phenylephrine Hydrochloride
ANDA #210666
Phenylephrine Hydrochloride Solution; Intravenous SUPPL-2 Fresenius Kabi Usa Labeling Approved
Pirfenidone
ANDA #212077
Pirfenidone Unknown ORIG-1 Sciegen Pharms Inc Tentative Approval
Succinylcholine Chloride
ANDA #213810
Succinylcholine Chloride Injectable; Injection SUPPL-1 Aspiro Labeling Approved
Tigecycline
NDA #205645
Tigecycline Powder; Intravenous SUPPL-4 Fresenius Kabi Usa Labeling Approved
Vimpat
NDA #022253
Lacosamide Tablet; Oral SUPPL-46 Ucb Inc Efficacy Approved
Vimpat
NDA #022253
Lacosamide Tablet; Oral SUPPL-48 Ucb Inc Efficacy Approved
Vimpat
NDA #022254
Lacosamide Solution; Intravenous SUPPL-36 Ucb Inc Efficacy Approved
Vimpat
NDA #022254
Lacosamide Solution; Intravenous SUPPL-38 Ucb Inc Efficacy Approved
Vimpat
NDA #022255
Lacosamide Solution; Oral SUPPL-27 Ucb Inc Efficacy Approved
Vimpat
NDA #022255
Lacosamide Solution; Oral SUPPL-30 Ucb Inc Efficacy Approved
Zenatane
ANDA #202099
Isotretinoin Capsule; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved
Zenatane
ANDA #202099
Isotretinoin Capsule; Oral SUPPL-20 Dr Reddys Labs Ltd Labeling Approved

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