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.
September 25, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-5 | Glaxosmithkline | Labeling | Approved |
September 24, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arthrotec
NDA #020607 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-36 | Pfizer | Labeling | Approved |
| Benlysta
BLA #125370 |
Belimumab | Injectable; Injection | SUPPL-71 | Human Genome Sciences Inc. | Efficacy | Approved |
| Implanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Implanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-20 | Organon Usa Inc | Labeling | Approved |
| Implanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Kalydeco
NDA #203188 |
Ivacaftor | Tablet; Oral | SUPPL-33 | Vertex Pharms | Efficacy | Approved |
| Kalydeco
NDA #207925 |
Ivacaftor | Granule; Oral | SUPPL-11 | Vertex Pharms Inc | Efficacy | Approved |
| Nexplanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Nexplanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-20 | Organon Usa Inc | Labeling | Approved |
| Nexplanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Revlimid
NDA #021880 |
Lenalidomide | Capsule; Oral | SUPPL-54 | Celgene | REMS | Approved |
| Reyataz
NDA #021567 |
Atazanavir Sulfate | Capsule; Oral | SUPPL-44 | Bristol Myers Squibb | Labeling | Approved |
| Reyataz
NDA #206352 |
Atazanavir Sulfate | Powder; Oral | SUPPL-8 | Bristol Myers Squibb | Labeling | Approved |
| Stivarga
NDA #203085 |
Regorafenib | Tablet; Oral | SUPPL-12 | Bayer Hlthcare | Labeling | Approved |
September 23, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lumify
NDA #208144 |
Brimonidine Tartrate | Solution/Drops; Ophthalmic | SUPPL-11 | Bausch and Lomb Inc | Labeling | Approved |
| Prosol 20% Sulfite Free In Plastic Container
NDA #020849 |
Amino Acids | Injectable; Injection | SUPPL-25 | Baxter Hlthcare | Labeling | Approved |
| Travasol 10% In Plastic Container
NDA #018931 |
Amino Acids | Injectable; Injection | SUPPL-55 | Baxter Hlthcare | Labeling | Approved |
| Travasol 5.5% In Plastic Container
NDA #018931 |
Amino Acids | Injectable; Injection | SUPPL-55 | Baxter Hlthcare | Labeling | Approved |
| Travasol 8.5% In Plastic Container
NDA #018931 |
Amino Acids | Injectable; Injection | SUPPL-55 | Baxter Hlthcare | Labeling | Approved |
September 22, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Eraxis
NDA #021632 |
Anidulafungin | Powder; Intravenous | SUPPL-27 | Vicuron | Efficacy | Approved |
| Eraxis
NDA #021632 |
Anidulafungin | Powder; Intravenous | SUPPL-29 | Vicuron | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #213158 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | ORIG-1 | Cisen | Approved | |
| Linzess
NDA #202811 |
Linaclotide | Capsule; Oral | SUPPL-16 | Allergan | Efficacy | Approved |
| Naftifine Hydrochloride
ANDA #210038 |
Naftifine Hydrochloride | Cream; Topical | ORIG-1 | Genzum | Approved | |
| Vancomycin Hydrochloride
ANDA #202274 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-1 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202274 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-3 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202275 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-1 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202275 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-3 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202275 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-4 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202464 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-1 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202464 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-3 | Emcure Pharms Ltd | Labeling | Approved |
September 21, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-3 | Natco Pharma Ltd | Labeling | Approved |
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-3 | Natco Pharma Ltd | Labeling | Approved |
| Bendamustine Hydrochloride
ANDA #205574 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Accord Hlthcare | Tentative Approval | |
| Butalbital, Acetaminophen and Caffeine
ANDA #203647 |
Acetaminophen; Butalbital; Caffeine | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Cetirizine Hydrochloride Allergy
ANDA #213105 |
Cetirizine Hydrochloride | Capsule; Oral | ORIG-1 | Catalent | Approved | |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-8 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-8 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-8 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #202114 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-2 | Rising | Labeling | Approved |
| Lidocaine and Prilocaine
ANDA #213253 |
Lidocaine; Prilocaine | Cream; Topical | ORIG-1 | Rhodes Pharms | Approved | |
| Palbociclib
ANDA #213098 |
Palbociclib | Unknown | ORIG-1 | Zydus Worldwide Dmcc | Tentative Approval | |
| Pilocarpine Hydrochloride
ANDA #214193 |
Pilocarpine Hydrochloride | Solution; Ophthalmic | ORIG-1 | Amneal | Approved | |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-1 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-1 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201967 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Glenmark Generics | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Sumatriptan
ANDA #213465 |
Sumatriptan | Spray; Nasal | ORIG-1 | Perrigo Uk Finco | Approved | |
| Sumatriptan
ANDA #213650 |
Sumatriptan | Spray; Nasal | ORIG-1 | Perrigo Uk Finco | Approved |
September 18, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Armonair Digihaler
NDA #208798 |
Fluticasone Propionate | Powder; Inhalation | SUPPL-7 | Teva Pharm | Labeling | Approved |
| Armonair Respiclick
NDA #208798 |
Fluticasone Propionate | Powder; Inhalation | SUPPL-7 | Teva Pharm | Labeling | Approved |
| Cefobid
NDA #050551 |
Cefoperazone Sodium | Injectable; Injection | SUPPL-46 | Pfizer | Labeling | Approved |
| Cinacalcet Hydrochloride
ANDA #208368 |
Cinacalcet Hydrochloride | Tablet; Oral | ORIG-1 | Dr Reddys | Approved | |
| Ilaris
BLA #125319 |
Canakinumab | Injectable; Subcutaneous | SUPPL-100 | Novartis Pharms | Labeling | Approved |
| Invirase
NDA #021785 |
Saquinavir Mesylate | Tablet; Oral | SUPPL-25 | Hoffmann-La Roche | Labeling | Approved |
| Invirase
NDA #021785 |
Saquinavir Mesylate | Tablet; Oral | SUPPL-25 | Hoffmann-La Roche | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-15 | Torrent Pharms Ltd | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-12 | Torrent Pharms Ltd | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-13 | Torrent Pharms Ltd | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-15 | Torrent Pharms Ltd | Labeling | Approved |
| Loratadine
ANDA #212795 |
Loratadine | Tablet, Orally Disintegrating; Oral | ORIG-1 | Tenshi | Approved | |
| Mefenamic Acid
ANDA #209209 |
Mefenamic Acid | Capsule; Oral | ORIG-1 | Strides Pharma | Approved | |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-84 | Bristol Myers Squibb | Efficacy | Approved |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-85 | Bristol Myers Squibb | Efficacy | Approved |
| Seroquel
NDA #020639 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-70 | Astrazeneca Pharms | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-41 | Astrazeneca | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-44 | Astrazeneca | Labeling | Approved |
| Vinorelbine Tartrate
ANDA #200148 |
Vinorelbine Tartrate | Injectable; Injection | SUPPL-6 | Mylan Labs Ltd | Labeling | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-112 | Bristol Myers Squibb | Efficacy | Approved |
September 17, 2020
| Drug Name and Application Number |
Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bivalirudin
ANDA #204876 |
Bivalirudin | Injectable; Intravenous | SUPPL-1 | Apotex | Labeling | Approved |
| Bivalirudin
ANDA #204876 |
Bivalirudin | Injectable; Intravenous | SUPPL-2 | Apotex | Labeling | Approved |
| Budesonide
ANDA #208851 |
Budesonide | Tablet, Extended Release; Oral | ORIG-1 | Mylan | Approved | |
| Desmopressin Acetate
ANDA #210223 |
Desmopressin Acetate | Injectable; Injection | ORIG-1 | Ubi | Approved | |
| Erythromycin Lactobionate
ANDA #211086 |
Erythromycin Lactobionate | Injectable; Injection | ORIG-1 | Exela Pharma | Approved | |
| Potassium Chloride
ANDA #210395 |
Potassium Chloride | Tablet, Extended Release; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Potassium Chloride 0.15% In Sodium Chloride 0.45%
ANDA #212347 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Potassium Chloride 0.3% and Sodium Chloride 0.9%
ANDA #212347 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Yonsa
NDA #210308 |
Abiraterone Acetate | Tablet; Oral | SUPPL-1 | Sun Pharma Global | Labeling | Approved |
September 25, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Nucala
BLA #761122 |
Mepolizumab | Injectable; Subcutaneous | SUPPL-5 | Glaxosmithkline | Labeling | Approved |
September 24, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Arthrotec
NDA #020607 |
Diclofenac Sodium; Misoprostol | Tablet, Delayed Release; Oral | SUPPL-36 | Pfizer | Labeling | Approved |
| Benlysta
BLA #125370 |
Belimumab | Injectable; Injection | SUPPL-71 | Human Genome Sciences Inc. | Efficacy | Approved |
| Implanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Implanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-20 | Organon Usa Inc | Labeling | Approved |
| Implanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Kalydeco
NDA #203188 |
Ivacaftor | Tablet; Oral | SUPPL-33 | Vertex Pharms | Efficacy | Approved |
| Kalydeco
NDA #207925 |
Ivacaftor | Granule; Oral | SUPPL-11 | Vertex Pharms Inc | Efficacy | Approved |
| Nexplanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Nexplanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-20 | Organon Usa Inc | Labeling | Approved |
| Nexplanon
NDA #021529 |
Etonogestrel | Implant; Implantation | SUPPL-19 | Organon Usa Inc | Labeling | Approved |
| Revlimid
NDA #021880 |
Lenalidomide | Capsule; Oral | SUPPL-54 | Celgene | REMS | Approved |
| Reyataz
NDA #021567 |
Atazanavir Sulfate | Capsule; Oral | SUPPL-44 | Bristol Myers Squibb | Labeling | Approved |
| Reyataz
NDA #206352 |
Atazanavir Sulfate | Powder; Oral | SUPPL-8 | Bristol Myers Squibb | Labeling | Approved |
| Stivarga
NDA #203085 |
Regorafenib | Tablet; Oral | SUPPL-12 | Bayer Hlthcare | Labeling | Approved |
September 23, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Lumify
NDA #208144 |
Brimonidine Tartrate | Solution/Drops; Ophthalmic | SUPPL-11 | Bausch and Lomb Inc | Labeling | Approved |
| Prosol 20% Sulfite Free In Plastic Container
NDA #020849 |
Amino Acids | Injectable; Injection | SUPPL-25 | Baxter Hlthcare | Labeling | Approved |
| Travasol 10% In Plastic Container
NDA #018931 |
Amino Acids | Injectable; Injection | SUPPL-55 | Baxter Hlthcare | Labeling | Approved |
| Travasol 5.5% In Plastic Container
NDA #018931 |
Amino Acids | Injectable; Injection | SUPPL-55 | Baxter Hlthcare | Labeling | Approved |
| Travasol 8.5% In Plastic Container
NDA #018931 |
Amino Acids | Injectable; Injection | SUPPL-55 | Baxter Hlthcare | Labeling | Approved |
September 22, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Eraxis
NDA #021632 |
Anidulafungin | Powder; Intravenous | SUPPL-27 | Vicuron | Efficacy | Approved |
| Eraxis
NDA #021632 |
Anidulafungin | Powder; Intravenous | SUPPL-29 | Vicuron | Labeling | Approved |
| Esomeprazole Magnesium
ANDA #213158 |
Esomeprazole Magnesium | Capsule, Delayed Rel Pellets; Oral | ORIG-1 | Cisen | Approved | |
| Linzess
NDA #202811 |
Linaclotide | Capsule; Oral | SUPPL-16 | Allergan | Efficacy | Approved |
| Naftifine Hydrochloride
ANDA #210038 |
Naftifine Hydrochloride | Cream; Topical | ORIG-1 | Genzum | Approved | |
| Vancomycin Hydrochloride
ANDA #202274 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-1 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202274 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-3 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202275 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-1 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202275 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-3 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202275 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-4 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202464 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-1 | Emcure Pharms Ltd | Labeling | Approved |
| Vancomycin Hydrochloride
ANDA #202464 |
Vancomycin Hydrochloride | Injectable; Injection | SUPPL-3 | Emcure Pharms Ltd | Labeling | Approved |
September 21, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-3 | Natco Pharma Ltd | Labeling | Approved |
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Azacitidine
ANDA #207234 |
Azacitidine | Powder; Intravenous, Subcutaneous | SUPPL-3 | Natco Pharma Ltd | Labeling | Approved |
| Bendamustine Hydrochloride
ANDA #205574 |
Bendamustine Hydrochloride | Powder; Iv (Infusion) | ORIG-1 | Accord Hlthcare | Tentative Approval | |
| Butalbital, Acetaminophen and Caffeine
ANDA #203647 |
Acetaminophen; Butalbital; Caffeine | Tablet; Oral | ORIG-1 | Strides Pharma | Approved | |
| Cetirizine Hydrochloride Allergy
ANDA #213105 |
Cetirizine Hydrochloride | Capsule; Oral | ORIG-1 | Catalent | Approved | |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-8 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-8 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #200292 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-8 | Prinston Inc | Labeling | Approved |
| Donepezil Hydrochloride
ANDA #202114 |
Donepezil Hydrochloride | Tablet; Oral | SUPPL-2 | Rising | Labeling | Approved |
| Lidocaine and Prilocaine
ANDA #213253 |
Lidocaine; Prilocaine | Cream; Topical | ORIG-1 | Rhodes Pharms | Approved | |
| Palbociclib
ANDA #213098 |
Palbociclib | Unknown | ORIG-1 | Zydus Worldwide Dmcc | Tentative Approval | |
| Pilocarpine Hydrochloride
ANDA #214193 |
Pilocarpine Hydrochloride | Solution; Ophthalmic | ORIG-1 | Amneal | Approved | |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-1 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-1 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #200482 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-2 | Natco Pharma Ltd | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201967 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Glenmark Generics | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Rizatriptan Benzoate
ANDA #201993 |
Rizatriptan Benzoate | Tablet; Oral | SUPPL-4 | Mylan Pharms Inc | Labeling | Approved |
| Sumatriptan
ANDA #213465 |
Sumatriptan | Spray; Nasal | ORIG-1 | Perrigo Uk Finco | Approved | |
| Sumatriptan
ANDA #213650 |
Sumatriptan | Spray; Nasal | ORIG-1 | Perrigo Uk Finco | Approved |
September 18, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Armonair Digihaler
NDA #208798 |
Fluticasone Propionate | Powder; Inhalation | SUPPL-7 | Teva Pharm | Labeling | Approved |
| Armonair Respiclick
NDA #208798 |
Fluticasone Propionate | Powder; Inhalation | SUPPL-7 | Teva Pharm | Labeling | Approved |
| Cefobid
NDA #050551 |
Cefoperazone Sodium | Injectable; Injection | SUPPL-46 | Pfizer | Labeling | Approved |
| Cinacalcet Hydrochloride
ANDA #208368 |
Cinacalcet Hydrochloride | Tablet; Oral | ORIG-1 | Dr Reddys | Approved | |
| Ilaris
BLA #125319 |
Canakinumab | Injectable; Subcutaneous | SUPPL-100 | Novartis Pharms | Labeling | Approved |
| Invirase
NDA #021785 |
Saquinavir Mesylate | Tablet; Oral | SUPPL-25 | Hoffmann-La Roche | Labeling | Approved |
| Invirase
NDA #021785 |
Saquinavir Mesylate | Tablet; Oral | SUPPL-25 | Hoffmann-La Roche | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-15 | Torrent Pharms Ltd | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-12 | Torrent Pharms Ltd | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-13 | Torrent Pharms Ltd | Labeling | Approved |
| Levetiracetam
ANDA #091338 |
Levetiracetam | Tablet, Extended Release; Oral | SUPPL-15 | Torrent Pharms Ltd | Labeling | Approved |
| Loratadine
ANDA #212795 |
Loratadine | Tablet, Orally Disintegrating; Oral | ORIG-1 | Tenshi | Approved | |
| Mefenamic Acid
ANDA #209209 |
Mefenamic Acid | Capsule; Oral | ORIG-1 | Strides Pharma | Approved | |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-84 | Bristol Myers Squibb | Efficacy | Approved |
| Opdivo
BLA #125554 |
Nivolumab | Injectable; Injection | SUPPL-85 | Bristol Myers Squibb | Efficacy | Approved |
| Seroquel
NDA #020639 |
Quetiapine Fumarate | Tablet; Oral | SUPPL-70 | Astrazeneca Pharms | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-41 | Astrazeneca | Labeling | Approved |
| Seroquel Xr
NDA #022047 |
Quetiapine Fumarate | Tablet, Extended Release; Oral | SUPPL-44 | Astrazeneca | Labeling | Approved |
| Vinorelbine Tartrate
ANDA #200148 |
Vinorelbine Tartrate | Injectable; Injection | SUPPL-6 | Mylan Labs Ltd | Labeling | Approved |
| Yervoy
BLA #125377 |
Ipilimumab | Injectable; Injection | SUPPL-112 | Bristol Myers Squibb | Efficacy | Approved |
September 17, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Bivalirudin
ANDA #204876 |
Bivalirudin | Injectable; Intravenous | SUPPL-1 | Apotex | Labeling | Approved |
| Bivalirudin
ANDA #204876 |
Bivalirudin | Injectable; Intravenous | SUPPL-2 | Apotex | Labeling | Approved |
| Budesonide
ANDA #208851 |
Budesonide | Tablet, Extended Release; Oral | ORIG-1 | Mylan | Approved | |
| Desmopressin Acetate
ANDA #210223 |
Desmopressin Acetate | Injectable; Injection | ORIG-1 | Ubi | Approved | |
| Erythromycin Lactobionate
ANDA #211086 |
Erythromycin Lactobionate | Injectable; Injection | ORIG-1 | Exela Pharma | Approved | |
| Potassium Chloride
ANDA #210395 |
Potassium Chloride | Tablet, Extended Release; Oral | ORIG-1 | Zydus Pharms | Approved | |
| Potassium Chloride 0.15% In Sodium Chloride 0.45%
ANDA #212347 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Potassium Chloride 0.3% and Sodium Chloride 0.9%
ANDA #212347 |
Potassium Chloride; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Yonsa
NDA #210308 |
Abiraterone Acetate | Tablet; Oral | SUPPL-1 | Sun Pharma Global | Labeling | Approved |
September 16, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Decitabine
NDA #205582 |
Decitabine | Powder; Intravenous | SUPPL-15 | Sun Pharma Global | Labeling | Approved |
| Decitabine
NDA #205582 |
Decitabine | Powder; Intravenous | SUPPL-15 | Sun Pharma Global | Labeling | Approved |
| Envarsus Xr
NDA #206406 |
Tacrolimus | Tablet, Extended Release; Oral | SUPPL-8 | Veloxis Pharms Inc | Labeling | Approved |
| Flecainide Acetate
ANDA #210683 |
Flecainide Acetate | Tablet; Oral | ORIG-1 | Beximco Pharms Usa | Approved | |
| Gabapentin
ANDA #206943 |
Gabapentin | Capsule; Oral | SUPPL-1 | Aci Healthcare Ltd | Labeling | Approved |
| Gabapentin
ANDA #206943 |
Gabapentin | Capsule; Oral | SUPPL-4 | Aci Healthcare Ltd | Labeling | Approved |
| Noxafil
NDA #022003 |
Posaconazole | Suspension; Oral | SUPPL-26 | Schering | Labeling | Approved |
| Noxafil
NDA #022003 |
Posaconazole | Suspension; Oral | SUPPL-26 | Schering | Labeling | Approved |
| Noxafil
NDA #205053 |
Posaconazole | Tablet, Delayed Release; Oral | SUPPL-10 | Merck Sharp Dohme | Labeling | Approved |
| Noxafil
NDA #205053 |
Posaconazole | Tablet, Delayed Release; Oral | SUPPL-10 | Merck Sharp Dohme | Labeling | Approved |
| Noxafil
NDA #205596 |
Posaconazole | Solution; Intravenous | SUPPL-10 | Merck Sharp Dohme | Labeling | Approved |
| Noxafil
NDA #205596 |
Posaconazole | Solution; Intravenous | SUPPL-10 | Merck Sharp Dohme | Labeling | Approved |
| Propofol
ANDA #205576 |
Propofol | Injectable; Injection | ORIG-1 | Innopharma | Approved |
September 15, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adcirca
NDA #022332 |
Tadalafil | Tablet; Oral | SUPPL-11 | Eli Lilly Co | Labeling | Approved |
| Brilinta
NDA #022433 |
Ticagrelor | Tablet; Oral | SUPPL-30 | Astrazeneca Pharms | Labeling | Approved |
| Butorphanol Tartrate
ANDA #078247 |
Butorphanol Tartrate | Injectable; Injection | SUPPL-5 | Hikma Farmaceutica | Labeling | Approved |
| Butorphanol Tartrate
ANDA #078400 |
Butorphanol Tartrate | Injectable; Injection | SUPPL-5 | Hikma Farmaceutica | Labeling | Approved |
| Colchicine
ANDA #211519 |
Colchicine | Tablet; Oral | SUPPL-2 | Zydus Pharms | Labeling | Approved |
| Colchicine
ANDA #211519 |
Colchicine | Tablet; Oral | SUPPL-2 | Zydus Pharms | Labeling | Approved |
| Dexmedetomidine Hydrochloride
ANDA #208266 |
Dexmedetomidine Hydrochloride | Injectable; Injection | ORIG-1 | Par Sterile Products | Approved | |
| Dextrose 5% and Sodium Chloride 0.225%
ANDA #211221 |
Dextrose; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Dextrose 5% and Sodium Chloride 0.45%
ANDA #211276 |
Dextrose; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Doxercalciferol
ANDA #205360 |
Doxercalciferol | Capsule; Oral | ORIG-1 | Avet | Approved | |
| Famotidine
ANDA #075709 |
Famotidine | Injectable; Injection | SUPPL-10 | Fresenius Kabi Usa | Labeling | Approved |
| Famotidine
ANDA #078641 |
Famotidine | Injectable; Injection | SUPPL-12 | Mylan Labs Ltd | Labeling | Approved |
| Famotidine Preservative Free
ANDA #075813 |
Famotidine | Injectable; Injection | SUPPL-11 | Fresenius Kabi Usa | Labeling | Approved |
| Famotidine Preservative Free
ANDA #078642 |
Famotidine | Injectable; Injection | SUPPL-8 | Mylan Labs Ltd | Labeling | Approved |
| Fluvastatin Sodium
ANDA #090595 |
Fluvastatin Sodium | Capsule; Oral | SUPPL-3 | Mylan Pharms Inc | Labeling | Approved |
| Glimepiride
ANDA #091220 |
Glimepiride | Tablet; Oral | SUPPL-15 | Micro Labs | Labeling | Approved |
| Lisinopril
ANDA #212041 |
Lisinopril | Tablet; Oral | ORIG-1 | Yiling | Approved | |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-7 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-8 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-9 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-16 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-7 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-8 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-9 | Jubilant Generics | Labeling | Approved |
| Olanzapine
ANDA #200221 |
Olanzapine | Tablet, Orally Disintegrating; Oral | SUPPL-16 | Jubilant Generics | Labeling | Approved |
| Tofacitinib
ANDA #212943 |
Tofacitinib | Unknown | ORIG-1 | Ajanta Pharma Ltd | Tentative Approval | |
| Ziprasidone Hydrochloride
ANDA #208988 |
Ziprasidone Hydrochloride | Capsule; Oral | SUPPL-1 | Cadila | Labeling | Approved |
| Ziprasidone Hydrochloride
ANDA #208988 |
Ziprasidone Hydrochloride | Capsule; Oral | SUPPL-2 | Cadila | Labeling | Approved |
| Ziprasidone Hydrochloride
ANDA #208988 |
Ziprasidone Hydrochloride | Capsule; Oral | SUPPL-1 | Cadila | Labeling | Approved |
| Ziprasidone Hydrochloride
ANDA #208988 |
Ziprasidone Hydrochloride | Capsule; Oral | SUPPL-2 | Cadila | Labeling | Approved |
September 14, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Acyclovir
ANDA #212173 |
Acyclovir | Capsule; Oral | ORIG-1 | Yiling | Approved | |
| Bupropion Hydrochloride
ANDA #207459 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Jubilant Generics | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #207459 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Jubilant Generics | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #207459 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Jubilant Generics | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #207459 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-1 | Jubilant Generics | Labeling | Approved |
| Bupropion Hydrochloride
ANDA #207459 |
Bupropion Hydrochloride | Tablet, Extended Release; Oral | SUPPL-5 | Jubilant Generics | Labeling | Approved |
| Chlorzoxazone
ANDA #212053 |
Chlorzoxazone | Tablet; Oral | ORIG-1 | I3 Pharms | Approved | |
| Dextrose 5% and Sodium Chloride 0.9%
ANDA #211211 |
Dextrose; Sodium Chloride | Injectable; Injection | ORIG-1 | Fresenius Kabi Usa | Approved | |
| Lenvima
NDA #206947 |
Lenvatinib Mesylate | Capsule; Oral | SUPPL-17 | Eisai Inc | Labeling | Approved |
September 13, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Botox
BLA #103000 |
Onabotulinumtoxina | Vial; Single-Use | SUPPL-5317 | Allergan | Labeling | Approved |
| Botox Cosmetic
BLA #103000 |
Onabotulinumtoxina | Vial; Single-Use | SUPPL-5317 | Allergan | Labeling | Approved |
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