Drugs@FDA: FDA Approved Drug Products

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 21, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cyklokapron
NDA #019281
Tranexamic Acid Injectable; Injection SUPPL-41 Pharmacia and Upjohn Labeling Approved
Docetaxel
NDA #202356
Docetaxel Injectable; Injection SUPPL-2 Pfizer Labs Labeling Approved
Docetaxel
NDA #202356
Docetaxel Injectable; Injection SUPPL-2 Pfizer Labs Labeling Approved
Dutasteride
ANDA #209909
Dutasteride Capsule; Oral ORIG-1 Humanwell Puracap Approved
Ezetimibe and Simvastatin
ANDA #208831
Ezetimibe; Simvastatin Tablet; Oral ORIG-1 Amneal Pharms Co Approved
Hailey Fe 1/20
ANDA #206597
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-28 ORIG-1 Glenmark Pharms Ltd Approved
Hydrocortisone Butyrate
ANDA #209556
Hydrocortisone Butyrate Lotion; Topical ORIG-1 Teligent Pharma Inc Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-1 Novo Nordisk Inc Labeling Approved
Palonosetron
NDA #208109
Palonosetron Hydrochloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Type 5 - New Formulation or New Manufacturer Approved
Pliaglis
NDA #021717
Lidocaine; Tetracaine Cream; Topical SUPPL-9 Taro Pharms Labeling Approved
Pliaglis
NDA #021717
Lidocaine; Tetracaine Cream; Topical SUPPL-9 Taro Pharms Labeling Approved
Spinraza
NDA #209531
Nusinersen Sodium Solution; Intrathecal SUPPL-2 Biogen Idec Labeling Approved
Tivicay
NDA #204790
Dolutegravir Sodium Tablet; Oral SUPPL-14 Viiv Hlthcare Efficacy Approved
Triumeq
NDA #205551
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-11 Viiv Hlthcare Efficacy Approved

November 20, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #209734
Acetazolamide Tablet; Oral ORIG-1 Strides Pharma Approved
Aspirin
NDA #203697
Aspirin Capsule; Oral SUPPL-2 Plx Pharma Labeling Approved
Clonidine Hydrochloride
ANDA #209686
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Ajanta Pharma Ltd Approved
Clonidine Hydrochloride
ANDA #209757
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Xiamen Lp Pharm Co Approved
Clonidine Hydrochloride
ANDA #210052
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Amneal Pharms Ny Approved
Dexmethylphenidate Hydrochloride
ANDA #208756
Dexmethylphenidate Hydrochloride Tablet; Oral ORIG-1 Rhodes Pharms Approved
Dyna-Hex
NDA #020111
Chlorhexidine Gluconate Solution; Topical SUPPL-9 Bajaj Medical Llc Labeling Approved
Emtricitabine;Rilpivirine;Tenofovir Disoproxil Fumarate
ANDA #208452
Emtricitabine;Rilpivirine;Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Mylan Pharms Inc Tentative Approval
Erythromycin
ANDA #208100
Erythromycin Solution; Topical ORIG-1 Teligent Pharma Inc Approved
Etoposide
ANDA #203507
Etoposide Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Fluoxetine Hydrochloride
ANDA #209695
Fluoxetine Hydrochloride Tablet; Oral ORIG-1 Inventia Hlthcare Approved
Myleran
ANDA #208536
Busulfan Injectable; Injection ORIG-1 Aspen Global Inc Approved
Zykadia
NDA #205755
Ceritinib Capsule; Oral SUPPL-11 Novartis Pharms Corp Labeling Approved

November 17, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aerospan Hfa
NDA #021247
Flunisolide Aerosol, Metered; Inhalation SUPPL-16 Mylan Speciality Lp Labeling Approved
Auvi-Q
NDA #201739
Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-8 Kaleo Inc Efficacy Approved
Auvi-Q
NDA #201739
Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-9 Kaleo Inc Labeling Approved
Cefixime
ANDA #206144
Cefixime For Suspension; Oral ORIG-1 Sandoz Inc Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-1 Paddock Llc Labeling Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-1 Paddock Llc Labeling Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-3 Paddock Llc Manufacturing (CMC) Approved
Clozapine
ANDA #201824
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Pharms Inc Labeling Approved
Ethacrynate Sodium
ANDA #207758
Ethacrynate Sodium Injectable; Injection ORIG-1 Zydus Pharms Usa Inc Approved
Fentanyl Citrate
ANDA #207338
Fentanyl Citrate Tablet; Sublingual ORIG-1 Actavis Labs Fl Inc Approved
Ganciclovir
ANDA #204560
Ganciclovir Sodium Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Gemifloxacin Mesylate
ANDA #090466
Gemifloxacin Mesylate Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Gemifloxacin Mesylate
ANDA #090466
Gemifloxacin Mesylate Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Gemifloxacin Mesylate
ANDA #090466
Gemifloxacin Mesylate Tablet; Oral SUPPL-2 Orchid Hlthcare Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #204847
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral ORIG-1 Glenmark Pharms Ltd Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #088875
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-38 Wockhardt Labeling Approved
Ticagrelor
ANDA #208531
Ticagrelor Tablet; Oral ORIG-1 Amneal Pharms Co Tentative Approval
Trileptal
NDA #021014
Oxcarbazepine Tablet; Oral SUPPL-41 Novartis Labeling Approved
Trileptal
NDA #021285
Oxcarbazepine Suspension; Oral SUPPL-34 Novartis Labeling Approved
Verapamil Hydrochloride
ANDA #071880
Verapamil Hydrochloride Tablet; Oral SUPPL-12 Heritage Pharms Inc Labeling Approved
Verapamil Hydrochloride
ANDA #071880
Verapamil Hydrochloride Tablet; Oral SUPPL-13 Heritage Pharms Inc Labeling Approved
Verapamil Hydrochloride
ANDA #071881
Verapamil Hydrochloride Tablet; Oral SUPPL-12 Heritage Pharms Inc Labeling Approved
Verapamil Hydrochloride
ANDA #071881
Verapamil Hydrochloride Tablet; Oral SUPPL-14 Heritage Pharms Inc Labeling Approved

November 16, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Budesonide
ANDA #205710
Budesonide Suspension; Inhalation ORIG-1 Cipla Ltd Approved
Butenafine Hydrochloride
ANDA #205181
Butenafine Hydrochloride Cream; Topical ORIG-1 Taro Approved
Cabometyx
NDA #208692
Cabozantinib S-Malate Tablet; Oral SUPPL-1 Exelixis Inc Labeling Approved
Carbaglu
NDA #022562
Carglumic Acid Tablet; Oral SUPPL-5 Orphan Europe Labeling Approved
Cleocin
NDA #050537
Clindamycin Phosphate Swab; Topical SUPPL-39 Pharmacia and Upjohn Labeling Approved
Cleocin T
NDA #050537
Clindamycin Phosphate Solution; Topical SUPPL-39 Pharmacia and Upjohn Labeling Approved
Cleocin T
NDA #050600
Clindamycin Phosphate Lotion; Topical SUPPL-16 Pharmacia and Upjohn Labeling Approved
Cleocin T
NDA #050615
Clindamycin Phosphate Gel; Topical SUPPL-16 Pharmacia and Upjohn Labeling Approved
Decitabine
ANDA #208601
Decitabine Injectable; Intravenous ORIG-1 Cipla Ltd Approved
Fenofibrate (Micronized)
ANDA #207805
Fenofibrate Capsule; Oral ORIG-1 Cnty Line Pharms Approved
Fluoxetine Hydrochloride
ANDA #209419
Fluoxetine Hydrochloride Tablet; Oral ORIG-1 Par Pharm Inc Approved
Gazyva
BLA #125486
Obinutuzumab Injectable; Injection SUPPL-17 Genentech Efficacy Approved
Gazyva
BLA #125486
Obinutuzumab Injectable; Injection SUPPL-18 Genentech Labeling Approved
Guanfacine Hydrochloride
ANDA #205689
Guanfacine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Sun Pharm Inds Ltd Approved
Hemlibra
BLA #761083
Emicizumab Injectable; Injection ORIG-1 Genentech Inc Type 1 - New Molecular Entity Approved
Minocycline Hydrochloride
ANDA #203553
Minocycline Hydrochloride Tablet, Extended Release; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Mycophenolate Mofetil
ANDA #204076
Mycophenolate Mofetil Tablet; Oral ORIG-1 Zhejiang Hisun Pharm Approved
Sutent
NDA #021938
Sunitinib Malate Capsule; Oral SUPPL-33 Cppi Cv Efficacy Approved
Travasol 10% In Plastic Container
NDA #018931
Amino Acids Injectable; Injection SUPPL-49 Baxter Hlthcare Labeling Approved
Travasol 5.5% In Plastic Container
NDA #018931
Amino Acids Injectable; Injection SUPPL-49 Baxter Hlthcare Labeling Approved
Travasol 8.5% In Plastic Container
NDA #018931
Amino Acids Injectable; Injection SUPPL-49 Baxter Hlthcare Labeling Approved
Xyrem
NDA #021196
Sodium Oxybate Solution; Oral SUPPL-28 Jazz Pharms Labeling Approved

November 15, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acticlate
NDA #205931
Doxycycline Hyclate Tablet; Oral SUPPL-3 Aqua Pharms Llc Labeling Approved
Acticlate Cap
NDA #208253
Doxycycline Hyclate Capsule; Oral SUPPL-1 Aqua Pharms Labeling Approved
Buprenorphine; Naloxone
ANDA #207087
Buprenorphine;Naloxone Film; Buccal, Sublingual ORIG-1 Actavis Labs Ut Inc Tentative Approval
Darunavir
ANDA #206555
Darunavir Tablet; Oral ORIG-1 Teva Pharms Tentative Approval
Ketoconazole
ANDA #074971
Ketoconazole Tablet; Oral SUPPL-2 Teva Labeling Approved
Ketoconazole
ANDA #075273
Ketoconazole Tablet; Oral SUPPL-16 Teva Labeling Approved
Ketoconazole
ANDA #075319
Ketoconazole Tablet; Oral SUPPL-11 Taro Labeling Approved
Ketoconazole
ANDA #075362
Ketoconazole Tablet; Oral SUPPL-11 Pliva Labeling Approved
Ketoconazole
ANDA #075597
Ketoconazole Tablet; Oral SUPPL-10 Mylan Labeling Approved
Ketoconazole
ANDA #075597
Ketoconazole Tablet; Oral SUPPL-10 Mylan Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-10 Apotex Labeling Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-5 Dexcel Pharma Labeling Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-5 Dexcel Pharma Labeling Approved
Mepsevii
BLA #761047
Vestronidase Alfa-Vjbk Injectable; Injection ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved

November 14, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fasenra
BLA #761070
Benralizumab Injectable; Injection ORIG-1 Astrazeneca Ab Type 1 - New Molecular Entity Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-35 Astrazeneca Efficacy Approved
Tekturna
NDA #021985
Aliskiren Hemifumarate Tablet; Oral SUPPL-34 Noden Pharma Labeling Approved
Tekturna
NDA #210709
Aliskiren Pellets; Oral ORIG-1 Noden Pharma Type 3 - New Dosage Form Approved

November 21, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cyklokapron
NDA #019281
Tranexamic Acid Injectable; Injection SUPPL-41 Pharmacia and Upjohn Labeling Approved
Docetaxel
NDA #202356
Docetaxel Injectable; Injection SUPPL-2 Pfizer Labs Labeling Approved
Docetaxel
NDA #202356
Docetaxel Injectable; Injection SUPPL-2 Pfizer Labs Labeling Approved
Dutasteride
ANDA #209909
Dutasteride Capsule; Oral ORIG-1 Humanwell Puracap Approved
Ezetimibe and Simvastatin
ANDA #208831
Ezetimibe; Simvastatin Tablet; Oral ORIG-1 Amneal Pharms Co Approved
Hailey Fe 1/20
ANDA #206597
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral-28 ORIG-1 Glenmark Pharms Ltd Approved
Hydrocortisone Butyrate
ANDA #209556
Hydrocortisone Butyrate Lotion; Topical ORIG-1 Teligent Pharma Inc Approved
Novolog Mix 50/50
NDA #021810
Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-1 Novo Nordisk Inc Labeling Approved
Palonosetron
NDA #208109
Palonosetron Hydrochloride Injectable; Injection ORIG-1 Fresenius Kabi Usa Type 5 - New Formulation or New Manufacturer Approved
Pliaglis
NDA #021717
Lidocaine; Tetracaine Cream; Topical SUPPL-9 Taro Pharms Labeling Approved
Pliaglis
NDA #021717
Lidocaine; Tetracaine Cream; Topical SUPPL-9 Taro Pharms Labeling Approved
Spinraza
NDA #209531
Nusinersen Sodium Solution; Intrathecal SUPPL-2 Biogen Idec Labeling Approved
Tivicay
NDA #204790
Dolutegravir Sodium Tablet; Oral SUPPL-14 Viiv Hlthcare Efficacy Approved
Triumeq
NDA #205551
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-11 Viiv Hlthcare Efficacy Approved

November 20, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acetazolamide
ANDA #209734
Acetazolamide Tablet; Oral ORIG-1 Strides Pharma Approved
Aspirin
NDA #203697
Aspirin Capsule; Oral SUPPL-2 Plx Pharma Labeling Approved
Clonidine Hydrochloride
ANDA #209686
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Ajanta Pharma Ltd Approved
Clonidine Hydrochloride
ANDA #209757
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Xiamen Lp Pharm Co Approved
Clonidine Hydrochloride
ANDA #210052
Clonidine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Amneal Pharms Ny Approved
Dexmethylphenidate Hydrochloride
ANDA #208756
Dexmethylphenidate Hydrochloride Tablet; Oral ORIG-1 Rhodes Pharms Approved
Dyna-Hex
NDA #020111
Chlorhexidine Gluconate Solution; Topical SUPPL-9 Bajaj Medical Llc Labeling Approved
Emtricitabine;Rilpivirine;Tenofovir Disoproxil Fumarate
ANDA #208452
Emtricitabine;Rilpivirine;Tenofovir Disoproxil Fumarate Tablet; Oral ORIG-1 Mylan Pharms Inc Tentative Approval
Erythromycin
ANDA #208100
Erythromycin Solution; Topical ORIG-1 Teligent Pharma Inc Approved
Etoposide
ANDA #203507
Etoposide Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Fluoxetine Hydrochloride
ANDA #209695
Fluoxetine Hydrochloride Tablet; Oral ORIG-1 Inventia Hlthcare Approved
Myleran
ANDA #208536
Busulfan Injectable; Injection ORIG-1 Aspen Global Inc Approved
Zykadia
NDA #205755
Ceritinib Capsule; Oral SUPPL-11 Novartis Pharms Corp Labeling Approved

November 17, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aerospan Hfa
NDA #021247
Flunisolide Aerosol, Metered; Inhalation SUPPL-16 Mylan Speciality Lp Labeling Approved
Auvi-Q
NDA #201739
Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-8 Kaleo Inc Efficacy Approved
Auvi-Q
NDA #201739
Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-9 Kaleo Inc Labeling Approved
Cefixime
ANDA #206144
Cefixime For Suspension; Oral ORIG-1 Sandoz Inc Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-1 Paddock Llc Labeling Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-1 Paddock Llc Labeling Approved
Clobetasol Propionate
ANDA #090898
Clobetasol Propionate Spray; Topical SUPPL-3 Paddock Llc Manufacturing (CMC) Approved
Clozapine
ANDA #201824
Clozapine Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Pharms Inc Labeling Approved
Ethacrynate Sodium
ANDA #207758
Ethacrynate Sodium Injectable; Injection ORIG-1 Zydus Pharms Usa Inc Approved
Fentanyl Citrate
ANDA #207338
Fentanyl Citrate Tablet; Sublingual ORIG-1 Actavis Labs Fl Inc Approved
Ganciclovir
ANDA #204560
Ganciclovir Sodium Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Gemifloxacin Mesylate
ANDA #090466
Gemifloxacin Mesylate Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Gemifloxacin Mesylate
ANDA #090466
Gemifloxacin Mesylate Tablet; Oral SUPPL-1 Orchid Hlthcare Labeling Approved
Gemifloxacin Mesylate
ANDA #090466
Gemifloxacin Mesylate Tablet; Oral SUPPL-2 Orchid Hlthcare Labeling Approved
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
ANDA #204847
Ethinyl Estradiol; Norethindrone Acetate Tablet; Oral ORIG-1 Glenmark Pharms Ltd Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #088875
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-38 Wockhardt Labeling Approved
Ticagrelor
ANDA #208531
Ticagrelor Tablet; Oral ORIG-1 Amneal Pharms Co Tentative Approval
Trileptal
NDA #021014
Oxcarbazepine Tablet; Oral SUPPL-41 Novartis Labeling Approved
Trileptal
NDA #021285
Oxcarbazepine Suspension; Oral SUPPL-34 Novartis Labeling Approved
Verapamil Hydrochloride
ANDA #071880
Verapamil Hydrochloride Tablet; Oral SUPPL-12 Heritage Pharms Inc Labeling Approved
Verapamil Hydrochloride
ANDA #071880
Verapamil Hydrochloride Tablet; Oral SUPPL-13 Heritage Pharms Inc Labeling Approved
Verapamil Hydrochloride
ANDA #071881
Verapamil Hydrochloride Tablet; Oral SUPPL-12 Heritage Pharms Inc Labeling Approved
Verapamil Hydrochloride
ANDA #071881
Verapamil Hydrochloride Tablet; Oral SUPPL-14 Heritage Pharms Inc Labeling Approved

November 16, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Budesonide
ANDA #205710
Budesonide Suspension; Inhalation ORIG-1 Cipla Ltd Approved
Butenafine Hydrochloride
ANDA #205181
Butenafine Hydrochloride Cream; Topical ORIG-1 Taro Approved
Cabometyx
NDA #208692
Cabozantinib S-Malate Tablet; Oral SUPPL-1 Exelixis Inc Labeling Approved
Carbaglu
NDA #022562
Carglumic Acid Tablet; Oral SUPPL-5 Orphan Europe Labeling Approved
Cleocin
NDA #050537
Clindamycin Phosphate Swab; Topical SUPPL-39 Pharmacia and Upjohn Labeling Approved
Cleocin T
NDA #050537
Clindamycin Phosphate Solution; Topical SUPPL-39 Pharmacia and Upjohn Labeling Approved
Cleocin T
NDA #050600
Clindamycin Phosphate Lotion; Topical SUPPL-16 Pharmacia and Upjohn Labeling Approved
Cleocin T
NDA #050615
Clindamycin Phosphate Gel; Topical SUPPL-16 Pharmacia and Upjohn Labeling Approved
Decitabine
ANDA #208601
Decitabine Injectable; Intravenous ORIG-1 Cipla Ltd Approved
Fenofibrate (Micronized)
ANDA #207805
Fenofibrate Capsule; Oral ORIG-1 Cnty Line Pharms Approved
Fluoxetine Hydrochloride
ANDA #209419
Fluoxetine Hydrochloride Tablet; Oral ORIG-1 Par Pharm Inc Approved
Gazyva
BLA #125486
Obinutuzumab Injectable; Injection SUPPL-17 Genentech Efficacy Approved
Gazyva
BLA #125486
Obinutuzumab Injectable; Injection SUPPL-18 Genentech Labeling Approved
Guanfacine Hydrochloride
ANDA #205689
Guanfacine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Sun Pharm Inds Ltd Approved
Hemlibra
BLA #761083
Emicizumab Injectable; Injection ORIG-1 Genentech Inc Type 1 - New Molecular Entity Approved
Minocycline Hydrochloride
ANDA #203553
Minocycline Hydrochloride Tablet, Extended Release; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Mycophenolate Mofetil
ANDA #204076
Mycophenolate Mofetil Tablet; Oral ORIG-1 Zhejiang Hisun Pharm Approved
Sutent
NDA #021938
Sunitinib Malate Capsule; Oral SUPPL-33 Cppi Cv Efficacy Approved
Travasol 10% In Plastic Container
NDA #018931
Amino Acids Injectable; Injection SUPPL-49 Baxter Hlthcare Labeling Approved
Travasol 5.5% In Plastic Container
NDA #018931
Amino Acids Injectable; Injection SUPPL-49 Baxter Hlthcare Labeling Approved
Travasol 8.5% In Plastic Container
NDA #018931
Amino Acids Injectable; Injection SUPPL-49 Baxter Hlthcare Labeling Approved
Xyrem
NDA #021196
Sodium Oxybate Solution; Oral SUPPL-28 Jazz Pharms Labeling Approved

November 15, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Acticlate
NDA #205931
Doxycycline Hyclate Tablet; Oral SUPPL-3 Aqua Pharms Llc Labeling Approved
Acticlate Cap
NDA #208253
Doxycycline Hyclate Capsule; Oral SUPPL-1 Aqua Pharms Labeling Approved
Buprenorphine; Naloxone
ANDA #207087
Buprenorphine;Naloxone Film; Buccal, Sublingual ORIG-1 Actavis Labs Ut Inc Tentative Approval
Darunavir
ANDA #206555
Darunavir Tablet; Oral ORIG-1 Teva Pharms Tentative Approval
Ketoconazole
ANDA #074971
Ketoconazole Tablet; Oral SUPPL-2 Teva Labeling Approved
Ketoconazole
ANDA #075273
Ketoconazole Tablet; Oral SUPPL-16 Teva Labeling Approved
Ketoconazole
ANDA #075319
Ketoconazole Tablet; Oral SUPPL-11 Taro Labeling Approved
Ketoconazole
ANDA #075362
Ketoconazole Tablet; Oral SUPPL-11 Pliva Labeling Approved
Ketoconazole
ANDA #075597
Ketoconazole Tablet; Oral SUPPL-10 Mylan Labeling Approved
Ketoconazole
ANDA #075597
Ketoconazole Tablet; Oral SUPPL-10 Mylan Labeling Approved
Ketoconazole
ANDA #075912
Ketoconazole Tablet; Oral SUPPL-10 Apotex Labeling Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-5 Dexcel Pharma Labeling Approved
Lansoprazole
NDA #208025
Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-5 Dexcel Pharma Labeling Approved
Mepsevii
BLA #761047
Vestronidase Alfa-Vjbk Injectable; Injection ORIG-1 Ultragenyx Pharm Inc Type 1 - New Molecular Entity Approved

November 14, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fasenra
BLA #761070
Benralizumab Injectable; Injection ORIG-1 Astrazeneca Ab Type 1 - New Molecular Entity Approved
Faslodex
NDA #021344
Fulvestrant Injectable; Intramuscular SUPPL-35 Astrazeneca Efficacy Approved
Tekturna
NDA #021985
Aliskiren Hemifumarate Tablet; Oral SUPPL-34 Noden Pharma Labeling Approved
Tekturna
NDA #210709
Aliskiren Pellets; Oral ORIG-1 Noden Pharma Type 3 - New Dosage Form Approved

November 13, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Abilify Mycite
NDA #207202
Aripiprazole Tablet; Oral W/Sensor ORIG-1 Otsuka Pharm Co Ltd Type 4 - New Combination Approved
Acyclovir
ANDA #205591
Acyclovir Ointment; Topical ORIG-1 G and W Labs Inc Approved
Mucinex D
NDA #021585
Guaifenesin; Pseudoephedrine Hydrochloride Tablet, Extended Release; Oral SUPPL-33 Reckitt Benckiser Manufacturing (CMC) Approved
Mucinex Dm
NDA #021620
Dextromethorphan Hydrobromide; Guaifenesin Tablet, Extended Release; Oral SUPPL-38 Reckitt Benckiser Manufacturing (CMC) Approved
Mycophenolate Mofetil
ANDA #204077
Mycophenolate Mofetil Capsule; Oral ORIG-1 Zhejiang Hisun Pharm Approved
Omeprazole
NDA #022032
Omeprazole Tablet, Delayed Release; Oral SUPPL-38 Dexcel Pharma Labeling Approved
Pentobarbital Sodium
ANDA #203619
Pentobarbital Sodium Injectable; Injection ORIG-1 Custopharm Inc Approved
Ranitidine Hydrochloride
ANDA #207578
Ranitidine Hydrochloride Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Ranitidine Hydrochloride
ANDA #207579
Ranitidine Hydrochloride Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Simponi
BLA #125289
Golimumab Injectable; Injection SUPPL-137 Centocor Ortho Biotech Inc Labeling Approved
Simvastatin
ANDA #206557
Simvastatin Tablet; Oral ORIG-1 Hisun Pharm Hangzhou Approved

November 12, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Toviaz
NDA #022030
Fesoterodine Fumarate Tablet, Extended Release; Oral SUPPL-14 Pfizer Labeling Approved

November 9, 2017

Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adcetris
BLA #125388
Brentuximab Vedotin Injectable; Injection SUPPL-94 Seattle Genetics Efficacy Approved
Betamethasone Dipropionate
ANDA #206118
Betamethasone Dipropionate Ointment, Augmented; Topical ORIG-1 Teligent Pharma Inc Approved
Children's Fexofenadine Hydrochloride Allergy
ANDA #208123
Fexofenadine Hydrochloride Suspension; Oral ORIG-1 Taro Pharm Approved
Children's Fexofenadine Hydrochloride Hives
ANDA #208123
Fexofenadine Hydrochloride Suspension; Oral ORIG-1 Taro Pharm Approved
Cinvanti (Aprepitant) Injectable Emulsion
NDA #209296
Aprepitant Injectable; Injection ORIG-1 Heron Theraps Inc Type 3 - New Dosage Form Approved
Cytarabine
ANDA #206190
Cytarabine Injectable; Injection ORIG-1 Sagent Pharms Approved
Dactinomycin
ANDA #203385
Dactinomycin Injectable; Injection ORIG-1 Mylan Labs Ltd Approved
Daklinza
NDA #206843
Daclatasvir Dihydrochloride Tablet; Oral SUPPL-7 Bristol-Myers Squibb Labeling Approved
Epclusa
NDA #208341
Sofosbuvir; Velpatasvir Tablet; Oral SUPPL-9 Gilead Sciences Inc Labeling Approved
Harvoni
NDA #205834
Ledipasvir; Sofosbuvir Tablet; Oral SUPPL-24 Gilead Sciences Inc Labeling Approved
M.V.I. Adult
NDA #021625
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E; Vitamin K Injectable; Iv (Infusion) SUPPL-23 Hospira Labeling Approved
M.V.I. Adult (Pharmacy Bulk Package)
NDA #021643
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E; Vitamin K Injectable; Iv (Infusion) SUPPL-19 Hospira Labeling Approved
M.V.I. Pediatric
NDA #018920
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Phytonadione; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E For Solution; Iv (Infusion) SUPPL-36 Hospira Labeling Approved
M.V.I.-12
NDA #008809
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E Injectable; Injection SUPPL-73 Hospira Labeling Approved
M.V.I.-12
NDA #008809
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E Injectable; Injection SUPPL-73 Hospira Labeling Approved
M.V.I.-12
NDA #008809
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Hydrochloride; Vitamin A; Vitamin E Injectable; Injection SUPPL-73 Hospira Labeling Approved
M.V.I.-12
NDA #008809
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Hydrochloride; Vitamin A; Vitamin E Injectable; Injection SUPPL-73 Hospira Labeling Approved
M.V.I.-12 (Without Vitamin K)
NDA #008809
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E Injectable; Injection SUPPL-73 Hospira Labeling Approved
M.V.I.-12 (Without Vitamin K)
NDA #008809
Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Vitamin A; Vitamin E Injectable; Injection SUPPL-73 Hospira Labeling Approved
Moxifloxacin Hydrochloride
ANDA #202916
Moxifloxacin Hydrochloride Solution/Drops; Ophthalmic ORIG-1 Akorn Approved
Nulojix
BLA #125288
Belatacept Injectable; Injection SUPPL-74 Bristol Myers Squibb Labeling Approved
Nulojix
BLA #125288
Belatacept Injectable; Injection SUPPL-74 Bristol Myers Squibb Labeling Approved
Olysio
NDA #205123
Simeprevir Sodium Capsule; Oral SUPPL-14 Janssen Prods Labeling Approved
Omnipaque 240
NDA #020608
Iohexol Solution; Injection, Oral, Rectal SUPPL-38 Ge Healthcare Labeling Approved
Omnipaque 240
NDA #020608
Iohexol Solution; Injection, Oral, Rectal SUPPL-38 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #020608
Iohexol Solution; Injection, Oral, Rectal SUPPL-38 Ge Healthcare Labeling Approved
Omnipaque 300
NDA #020608
Iohexol Solution; Injection, Oral, Rectal SUPPL-38 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #020608
Iohexol Solution; Injection, Oral SUPPL-38 Ge Healthcare Labeling Approved
Omnipaque 350
NDA #020608
Iohexol Solution; Injection, Oral SUPPL-38 Ge Healthcare Labeling Approved
Oxycodone Hydrochloride
ANDA #209021
Oxycodone Hydrochloride Solution; Oral ORIG-1 Ascent Pharms Inc Approved
Sovaldi
NDA #204671
Sofosbuvir Tablet; Oral SUPPL-12 Gilead Sciences Inc Labeling Approved
Sprycel
NDA #021986
Dasatinib Tablet; Oral SUPPL-20 Bristol Myers Squibb Efficacy Approved
Technivie
NDA #207931
Ombitasvir; Paritaprevir; Ritonavir Tablet; Oral SUPPL-11 Abbvie Inc Labeling Approved
Viekira Pak (Copackaged)
NDA #206619
Dasabuvir Sodium ; Ombitasvir; Paritaprevir; Ritonavir Tablet, Tablet; Oral SUPPL-17 Abbvie Inc Labeling Approved
Viekira Xr
NDA #208624
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir Tablet, Extended Release; Oral SUPPL-5 Abbvie Inc Labeling Approved
Vosevi
NDA #209195
Sofosbuvir; Velpatasvir; Voxilaprevir Tablet; Oral SUPPL-2 Gilead Sciences Inc Labeling Approved
Vraylar
NDA #204370
Cariprazine Hydrochloride Capsule; Oral SUPPL-2 Forest Res Inst Inc Efficacy Approved
Vraylar
NDA #204370
Cariprazine Hydrochloride Capsule; Oral SUPPL-3 Forest Res Inst Inc Labeling Approved
Zepatier
NDA #208261
Elbasvir; Grazoprevir Tablet; Oral SUPPL-3 Merck Sharp Dohme Labeling Approved
Zepatier
NDA #208261
Elbasvir; Grazoprevir Tablet; Oral SUPPL-3 Merck Sharp Dohme Labeling Approved

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