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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