Drugs@FDA: FDA Approved Drug Products

New and Generic Drug Approvals

January 19, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Seebri
NDA #207923
Glycopyrrolate Powder; Inhalation SUPPL-2 Novartis Pharms Corp LABELING Approved

January 18, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Aspirin and Dipyridamole
ANDA #206739
Aspirin; Dipyridamole Capsule, Extended Release; Oral ORIG-1 Sandoz Inc Approved
Benlysta
BLA #125370
Belimumab Injectable; Injection SUPPL-57 Human Genome Sciences Inc. LABELING Approved
Clindesse
NDA #050793
Clindamycin Phosphate Cream; Vaginal SUPPL-22 Perrigo Pharma Intl MANUF (CMC) Approved
Imbruvica
NDA #205552
Ibrutinib Capsule; Oral SUPPL-16 Pharmacyclics Inc EFFICACY Approved
Janumet
NDA #022044
Metformin Hydrochloride; Sitagliptin Phosphate Tablet; Oral SUPPL-39 Merck Sharp Dohme LABELING Approved
Janumet
NDA #022044
Metformin Hydrochloride; Sitagliptin Phosphate Tablet; Oral SUPPL-40 Merck Sharp Dohme LABELING Approved
Janumet Xr
NDA #202270
Metformin Hydrochloride; Sitagliptin Phosphate Tablet, Extended Release; Oral SUPPL-15 Merck Sharp Dohme LABELING Approved
Janumet Xr
NDA #202270
Metformin Hydrochloride; Sitagliptin Phosphate Tablet, Extended Release; Oral SUPPL-16 Merck Sharp Dohme LABELING Approved
Januvia
NDA #021995
Sitagliptin Phosphate Tablet; Oral SUPPL-38 Merck Sharp Dohme LABELING Approved
Kombiglyze Xr
NDA #200678
Metformin Hydrochloride; Saxagliptin Hydrochloride Tablet, Extended Release; Oral SUPPL-19 Astrazeneca Ab LABELING Approved
Kombiglyze Xr
NDA #200678
Metformin Hydrochloride; Saxagliptin Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Astrazeneca Ab LABELING Approved
Onglyza
NDA #022350
Saxagliptin Hydrochloride Tablet; Oral SUPPL-19 Astrazeneca Ab LABELING Approved
Quetiapine Fumarate
ANDA #206252
Quetiapine Fumarate Tablet, Extended Release; Oral ORIG-1 Accord Hlthcare Inc Tentative Approval

January 17, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Adempas
NDA #204819
Riociguat Tablet; Oral SUPPL-6 Bayer Hlthcare REMS Approved
Flurazepam Hydrochloride
ANDA #070444
Flurazepam Hydrochloride Capsule; Oral SUPPL-12 Par Pharm LABELING Approved
Flurazepam Hydrochloride
ANDA #070445
Flurazepam Hydrochloride Capsule; Oral SUPPL-12 Par Pharm LABELING Approved
Ibuprofen
ANDA #203599
Ibuprofen Capsule; Oral SUPPL-2 Sofgen Pharms LABELING Approved
Lexiscan
NDA #022161
Regadenoson Solution; Intravenous SUPPL-13 Astellas LABELING Approved
Saizen
NDA #019764
Somatropin Recombinant Injectable; Injection SUPPL-79 Emd Serono MANUF (CMC) Approved
Sodium Oxybate
ANDA #202090
Sodium Oxybate Solution; Oral ORIG-1 West-Ward Pharms Int Approved

January 13, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Codeine Phosphate and Chlorpheniramine Maleate
NDA #206323
Chlorpheniramine Maleate; Codeine Phosphate Tablet, Extended Release; Oral SUPPL-4 Spriaso Llc LABELING Approved
Cordran
NDA #016455
Flurandrenolide Tape; Topical SUPPL-25 Allergan Sales Llc MANUF (CMC) Approved
Eligard
NDA #021343
Leuprolide Acetate Injectable; Subcutaneous SUPPL-34 Tolmar Therap MANUF (CMC) Approved
Flowtuss
NDA #022424
Guaifenesin; Hydrocodone Bitartrate Solution; Oral SUPPL-1 Mission Pharmacal Co LABELING Approved
Fluoxetine Hydrochloride
ANDA #076024
Fluoxetine Hydrochloride Tablet; Oral SUPPL-4 Sandoz LABELING Approved
Homatropine Methylbromide and Hydrocodone Bitartrate
ANDA #040295
Homatropine Methylbromide; Hydrocodone Bitartrate Tablet; Oral SUPPL-8 Actavis Elizabeth LABELING Approved
Homatropine Methylbromide and Hydrocodone Bitartrate
ANDA #091528
Homatropine Methylbromide; Hydrocodone Bitartrate Tablet; Oral SUPPL-1 Novel Labs Inc LABELING Approved
Hycodan
NDA #005213
Homatropine Methylbromide; Hydrocodone Bitartrate Syrup; Oral SUPPL-38 Endo Pharms LABELING Approved
Hycodan
NDA #005213
Homatropine Methylbromide; Hydrocodone Bitartrate Tablet; Oral SUPPL-38 Endo Pharms LABELING Approved
Hycofenix
NDA #022279
Guaifenesin; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride Solution; Oral SUPPL-1 Mission Pharmacal Co LABELING Approved
Hydrocodone Bitartrate and Homatropine Methylbromide
ANDA #040613
Homatropine Methylbromide; Hydrocodone Bitartrate Syrup; Oral SUPPL-9 Hi Tech Pharma LABELING Approved
Hydrocodone Bitartrate and Homatropine Methylbromide
ANDA #088008
Homatropine Methylbromide; Hydrocodone Bitartrate Syrup; Oral SUPPL-17 Wockhardt LABELING Approved
Hydrocodone Bitartrate and Homatropine Methylbromide
ANDA #088017
Homatropine Methylbromide; Hydrocodone Bitartrate Syrup; Oral SUPPL-48 Actavis Mid Atlantic LABELING Approved
Librax
NDA #012750
Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral SUPPL-65 Valeant Pharms LABELING Approved
Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container
NDA #019830
Lidocaine Hydrochloride Injectable; Injection SUPPL-20 B Braun MANUF (CMC) Approved
Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container
NDA #019830
Lidocaine Hydrochloride Injectable; Injection SUPPL-20 B Braun MANUF (CMC) Approved
Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container
NDA #019830
Lidocaine Hydrochloride Injectable; Injection SUPPL-20 B Braun MANUF (CMC) Approved
Methotrexate Sodium
ANDA #207812
Methotrexate Sodium Tablet; Oral ORIG-1 Zydus Pharms Usa Inc Approved
Obredon
NDA #205474
Guaifenesin; Hydrocodone Bitartrate Solution; Oral SUPPL-3 Sovereign Pharms LABELING Approved
Phenergan Vc W/ Codeine
NDA #008306
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride Syrup; Oral SUPPL-32 Ani Pharms LABELING Approved
Phenergan W/ Codeine
NDA #008306
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-32 Ani Pharms LABELING Approved
Piperacillin and Tazobactam
ANDA #207847
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection ORIG-1 Apollo Pharms Inc Approved
Piperacillin and Tazobactam
ANDA #207848
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection ORIG-1 Apollo Pharms Inc Approved
Piperacillin; Tazobactam
ANDA #207848
Piperacillin;Tazobactam Injectable; Injection ORIG-1 Apollo Pharms Inc Approved
Prometh Hydrochloride,Phenylephrine Hydrochloride W/Codeine Phosphate
ANDA #040660
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride Syrup; Oral SUPPL-19 Vintage LABELING Approved
Prometh Vc W/ Codeine
ANDA #088764
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride Syrup; Oral SUPPL-85 Actavis Mid Atlantic LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #040151
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-15 Hi Tech Pharma LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #088763
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-86 Actavis Mid Atlantic LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #088875
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-37 Wockhardt LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #089647
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-11 Pharm Assoc LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #090180
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-6 Nostrum Labs Inc LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #200386
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-3 Tris Pharma Inc LABELING Approved
Promethazine Hydrochloride and Codeine Phosphate
ANDA #200894
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-1 Amneal Pharms LABELING Approved
Promethazine Hydrochloride, Phenylephrine Hydrochloride W/Codeine Phosphate
ANDA #040674
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride Syrup; Oral SUPPL-2 Hi-Tech Pharma Co LABELING Approved
Promethazine Hydrochloride,Phenylephrine Hydrochloride W/Codeine Phosphate
ANDA #200963
Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride Syrup; Oral SUPPL-1 Amneal Pharms LABELING Approved
Promethazine Hydrochloride; Codeine Phosphate
ANDA #090180
Promethazine Hydrochloride; Codeine Phosphate Syrup; Oral SUPPL-6 Nostrum Labs Inc LABELING Approved
Promethazine With Codeine
ANDA #040650
Codeine Phosphate; Promethazine Hydrochloride Syrup; Oral SUPPL-17 Vintage LABELING Approved
Rezira
NDA #022442
Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride Solution; Oral SUPPL-9 Cypress Pharm LABELING Approved
Saphris
NDA #022117
Asenapine Maleate Tablet; Sublingual SUPPL-20 Forest Labs Llc LABELING Approved
Saphris
NDA #022117
Asenapine Maleate Tablet; Sublingual SUPPL-21 Forest Labs Llc LABELING Approved
Soliris
BLA #125166
Eculizumab Injectable; Iv (Infusion) SUPPL-417 Alexion Pharm LABELING Approved
Triacin-C
ANDA #088704
Codeine Phosphate; Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride Syrup; Oral SUPPL-34 Sti Pharma Llc LABELING Approved
Tussigon
ANDA #088508
Homatropine Methylbromide; Hydrocodone Bitartrate Tablet; Oral SUPPL-18 King Pharms LABELING Approved
Tussionex Pennkinetic
NDA #019111
Chlorpheniramine Polistirex; Hydrocodone Polistirex Suspension, Extended Release; Oral SUPPL-19 Ucb Inc LABELING Approved
Tuzistra Xr
NDA #207768
Chlorpheniramine Polistirex; Codeine Polistirex Suspension, Extended Release; Oral SUPPL-4 Vernalis R and D Ltd LABELING Approved
Vituz
NDA #204307
Chlorpheniramine Maleate; Hydrocodone Bitartrate Solution; Oral SUPPL-3 Cypress Pharm LABELING Approved
Zutripro
NDA #022439
Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride Solution; Oral SUPPL-9 Cypress Pharm LABELING Approved

January 12, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fentora
NDA #021947
Fentanyl Citrate Tablet; Buccal, Sublingual SUPPL-26 Cephalon MANUF (CMC) Approved
Fluoxetine Hydrochloride
ANDA #076024
Fluoxetine Hydrochloride Tablet; Oral SUPPL-3 Sandoz LABELING Approved
Levo-T
NDA #021342
Levothyroxine Sodium Tablet; Oral SUPPL-25 Alara Pharm MANUF (CMC) Approved
Norditropin
NDA #021148
Somatropin Recombinant Injectable; Injection SUPPL-47 Novo Nordisk Inc MANUF (CMC) Approved
Norditropin Flexpro
NDA #021148
Somatropin Recombinant Injectable; Injection SUPPL-47 Novo Nordisk Inc MANUF (CMC) Approved
Norditropin Nordiflex
NDA #021148
Somatropin Recombinant Injectable; Injection SUPPL-47 Novo Nordisk Inc MANUF (CMC) Approved
Septocaine
NDA #020971
Articaine Hydrochloride; Epinephrine Bitartrate Injectable; Injection SUPPL-36 Deproco MANUF (CMC) Approved
Suboxone
NDA #022410
Buprenorphine Hydrochloride; Naloxone Hydrochloride Film; Buccal, Sublingual SUPPL-28 Indivior Inc MANUF (CMC) Approved
Triamcinolone Acetonide
ANDA #205592
Triamcinolone Acetonide Paste; Dental ORIG-1 G and W Labs Inc Approved

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