Drugs@FDA: FDA Approved Drug Products

New and Generic Drug Approvals

March 27, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Symbyax
NDA #021520
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-42 Lilly LABELING Approved
Zejula
NDA #208447
Niraparib Capsule; Oral ORIG-1 Tesaro Inc TYPE 1 Approved

March 24, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Allergy and Congestion Relief
NDA #022113
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-2 Pfizer LABELING Approved
Advil Allergy Sinus
NDA #021441
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride Tablet; Oral SUPPL-12 Pfizer LABELING Approved
Advil Cold and Sinus
NDA #021374
Ibuprofen; Pseudoephedrine Hydrochloride Capsule; Oral SUPPL-11 Pfizer LABELING Approved
Advil Congestion Relief
NDA #022565
Ibuprofen; Phenylephrine Hydrochloride Tablet; Oral SUPPL-3 Pfizer LABELING Approved
Bicnu
NDA #017422
Carmustine Injectable; Injection SUPPL-55 Emcure Pharms Ltd LABELING Approved
Children's Advil Allergy Sinus
NDA #021587
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride Suspension; Oral SUPPL-6 Pfizer LABELING Approved
Children's Advil Cold
NDA #021373
Ibuprofen; Pseudoephedrine Hydrochloride Suspension; Oral SUPPL-13 Pfizer LABELING Approved
Neurontin
NDA #020235
Gabapentin Capsule; Oral SUPPL-62 Pfizer Pharms LABELING Approved
Neurontin
NDA #020882
Gabapentin Tablet; Oral SUPPL-45 Pfizer Pharms LABELING Approved
Neurontin
NDA #021129
Gabapentin Solution; Oral SUPPL-44 Parke Davis LABELING Approved
Pediatric Advil
NDA #020812
Ibuprofen Suspension/Drops; Oral SUPPL-23 Pfizer LABELING Approved
Prozac
NDA #018936
Fluoxetine Hydrochloride Capsule; Oral SUPPL-103 Eli Lilly and Co LABELING Approved
Prozac Weekly
NDA #021235
Fluoxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-23 Lilly LABELING Approved
Sarafem
NDA #018936
Fluoxetine Hydrochloride Capsule; Oral SUPPL-103 Eli Lilly and Co LABELING Approved
Symbyax
NDA #021520
Fluoxetine Hydrochloride; Olanzapine Capsule; Oral SUPPL-50 Lilly LABELING Approved
Vimpat
NDA #022253
Lacosamide Tablet; Oral SUPPL-37 Ucb Inc LABELING Approved
Vimpat
NDA #022254
Lacosamide Solution; Intravenous SUPPL-29 Ucb Inc LABELING Approved
Vimpat
NDA #022255
Lacosamide Solution; Oral SUPPL-21 Ucb Inc LABELING Approved

March 23, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Advil Cold and Sinus
NDA #019771
Ibuprofen; Pseudoephedrine Hydrochloride Tablet; Oral SUPPL-40 Pfizer LABELING Approved
Bavencio
BLA #761049
Avelumab Injectable; Injection ORIG-1 Emd Serono Inc TYPE 1 Approved
Buprenorphine Hydrochloride and Naloxone Hydrochloride
ANDA #201633
Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-1 Sun Pharm Inds Ltd LABELING Approved
Butorphanol Tartrate
ANDA #075499
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-22 Apotex Inc LABELING Approved
Butorphanol Tartrate
ANDA #075824
Butorphanol Tartrate Spray, Metered; Nasal SUPPL-9 West-Ward Pharms Int LABELING Approved
Children's Advil
NDA #020589
Ibuprofen Suspension; Oral SUPPL-34 Pfizer LABELING Approved
Children's Advil-Flavored
NDA #020589
Ibuprofen Suspension; Oral SUPPL-34 Pfizer LABELING Approved
Dapsone
ANDA #204380
Dapsone Tablet; Oral ORIG-1 Actavis Llc Approved
Duloxetine Hydrochloride
ANDA #204815
Duloxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral ORIG-1 Macleods Pharms Ltd Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040826
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-8 Sun Pharm Inds Ltd LABELING Approved
Levoleucovorin Calcium
NDA #208723
Levoleucovorin Calcium Powder; Iv (Infusion) SUPPL-2 Actavis Llc LABELING Approved
Requip Xl
NDA #022008
Ropinirole Hydrochloride Tablet, Extended Release; Oral SUPPL-9 Glaxosmithkline Llc EFFICACY Approved
Symproic
NDA #208854
Naldemedine Tablet; Oral ORIG-1 Shionogi Inc TYPE 1 Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #090460
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-6 Zydus Pharms Usa Inc LABELING Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #201952
Acetaminophen; Tramadol Hydrochloride Tablet; Oral SUPPL-6 Micro Labs Ltd India LABELING Approved
Trileptal
NDA #021014
Oxcarbazepine Tablet; Oral SUPPL-36 Novartis LABELING Approved
Trileptal
NDA #021285
Oxcarbazepine Suspension; Oral SUPPL-31 Novartis LABELING Approved

March 22, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anoro Ellipta
NDA #203975
Umeclidinium Bromide; Vilanterol Trifenatate Powder; Inhalation SUPPL-5 Glaxosmithkline LABELING Approved
Buprenorphine Hydrochloride
ANDA #090360
Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-13 Barr LABELING Approved
Dermabet
ANDA #072041
Betamethasone Valerate Cream; Topical SUPPL-23 Taro LABELING Approved
Desogestrel and Ethinyl Estradiol
ANDA #206853
Desogestrel; Ethinyl Estradiol Tablet; Oral-28 ORIG-1 Aurobindo Pharma Ltd Approved
Epaned Kit
NDA #204308
Enalapril Maleate For Solution; Oral SUPPL-6 Silvergate Pharms LABELING Approved
Fingolimod
ANDA #207965
Fingolimod Capsule; Oral ORIG-1 Par Pharm Inc Tentative Approval
Fingolimod
ANDA #207991
Fingolimod Capsule; Oral ORIG-1 Accord Hlthcare Inc Tentative Approval
Glipizide
ANDA #074550
Glipizide Tablet; Oral SUPPL-11 Accord Hlthcare LABELING Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076604
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-18 Actavis Labs Fl Inc LABELING Approved
Hydrocodone Bitartrate and Ibuprofen
ANDA #076604
Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-19 Actavis Labs Fl Inc LABELING Approved
Melphalan
ANDA #207809
Melphalan Tablet; Oral ORIG-1 Alvogen Malta Approved
Nexterone
NDA #022325
Amiodarone Hydrochloride Injectable; Injection SUPPL-14 Baxter Hlthcare LABELING Approved
Oxycodone and Acetaminophen
ANDA #207419
Acetaminophen; Oxycodone Hydrochloride Tablet; Oral ORIG-1 Ascent Pharms Inc Approved
Piperacillin and Tazobactam
ANDA #206996
Piperacillin Sodium; Tazobactam Sodium Injectable; Injection ORIG-1 Wockhardt Bio Ag Approved
Technivie
NDA #207931
Ombitasvir; Paritaprevir; Ritonavir Tablet; Oral SUPPL-7 Abbvie Inc LABELING Approved
Technivie
NDA #207931
Ombitasvir; Paritaprevir; Ritonavir Tablet; Oral SUPPL-9 Abbvie Inc LABELING Approved
Tobramycin
ANDA #208964
Tobramycin Solution; Inhalation ORIG-1 Lupin Atlantis Approved
Tramadol Hydrochloride and Acetaminophen
ANDA #207152
Acetaminophen; Tramadol Hydrochloride Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Viekira Pak (Copackaged)
NDA #206619
Dasabuvir Sodium ; Ombitasvir; Paritaprevir; Ritonavir Tablet, Tablet; Oral SUPPL-13 Abbvie Inc LABELING Approved
Viekira Pak (Copackaged)
NDA #206619
Dasabuvir Sodium ; Ombitasvir; Paritaprevir; Ritonavir Tablet, Tablet; Oral SUPPL-15 Abbvie Inc LABELING Approved
Viekira Xr
NDA #208624
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir Tablet, Extended Release; Oral SUPPL-1 Abbvie Inc LABELING Approved
Viekira Xr
NDA #208624
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir Tablet, Extended Release; Oral SUPPL-3 Abbvie Inc LABELING Approved

March 21, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Cilostazol
ANDA #077022
Cilostazol Tablet; Oral SUPPL-8 Corepharma LABELING Approved
Cilostazol
ANDA #077150
Cilostazol Tablet; Oral SUPPL-6 Corepharma LABELING Approved
Ciloxan
NDA #019992
Ciprofloxacin Hydrochloride Solution/Drops; Ophthalmic SUPPL-26 Novartis Pharms Corp LABELING Approved
Gattex Kit
NDA #203441
Teduglutide Recombinant Powder; Subcutaneous SUPPL-10 Nps Pharms Inc REMS Approved
Lazanda
NDA #022569
Fentanyl Citrate Spray, Metered; Nasal SUPPL-24 Depomed Inc LABELING Approved
Opsumit
NDA #204410
Macitentan Tablet; Oral SUPPL-11 Actelion Pharms Ltd LABELING Approved
Oxaliplatin
ANDA #207474
Oxaliplatin Injectable; Iv (Infusion) ORIG-1 Accord Hlthcare Approved
Prochlorperazine Edisylate
ANDA #089903
Prochlorperazine Edisylate Injectable; Injection SUPPL-21 West-Ward Pharms Int LABELING Approved
Rosuvastatin Calcium
ANDA #206465
Rosuvastatin Calcium Tablet; Oral ORIG-1 Alkem Labs Ltd Approved
Technescan Pyp Kit
NDA #017538
Technetium Tc-99m Pyrophosphate Kit Injectable; Injection SUPPL-19 Mallinkrodt Nuclear LABELING Approved
Xadago
NDA #207145
Safinamide Tablet; Oral ORIG-1 Newron Pharms Us Inc TYPE 1 Approved
Zoledronic Acid
ANDA #090621
Zoledronic Acid Injectable; Iv (Infusion) SUPPL-2 Hospira Inc LABELING Approved
Zoledronic Acid
ANDA #090621
Zoledronic Acid Injectable; Iv (Infusion) SUPPL-4 Hospira Inc LABELING Approved
Zymar
NDA #021493
Gatifloxacin Solution/Drops; Ophthalmic SUPPL-11 Allergan LABELING Approved

March 20, 2017

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Anexsia 5/325
ANDA #040409
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-25 Mallinckrodt MANUF (CMC) Approved
Cambia
NDA #022165
Diclofenac Potassium For Solution; Oral SUPPL-12 Depomed Inc LABELING Approved
Cipro Hc
NDA #020805
Ciprofloxacin Hydrochloride; Hydrocortisone Suspension/Drops; Otic SUPPL-11 Novartis Pharms Corp LABELING Approved
Clobetasol Propionate
ANDA #208933
Clobetasol Propionate Ointment; Topical ORIG-1 Glenmark Pharms Approved
Epzicom
NDA #021652
Abacavir Sulfate; Lamivudine Tablet; Oral SUPPL-22 Viiv Hlthcare LABELING Approved
Hydrocodone Bitartrate and Acetaminophen
ANDA #040400
Acetaminophen; Hydrocodone Bitartrate Tablet; Oral SUPPL-25 Mallinckrodt MANUF (CMC) Approved
Pred-G
NDA #050586
Gentamicin Sulfate; Prednisolone Acetate Suspension/Drops; Ophthalmic SUPPL-31 Allergan LABELING Approved
Pred-G
NDA #050612
Gentamicin Sulfate; Prednisolone Acetate Ointment; Ophthalmic SUPPL-20 Allergan LABELING Approved
Zembrace Symtouch
NDA #208223
Sumatriptan Succinate Solution; Subcutaneous SUPPL-3 Dr Reddys Labs Ltd LABELING Approved
Ziagen
NDA #020977
Abacavir Sulfate Tablet; Oral SUPPL-32 Viiv Hlthcare LABELING Approved
Ziagen
NDA #020978
Abacavir Sulfate Solution; Oral SUPPL-35 Viiv Hlthcare LABELING Approved

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