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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