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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2013

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2013 EXELON
NDA #020823		 SUPPL-9 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 EXELON
NDA #020823		 SUPPL-27 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 EXELON
NDA #020823		 SUPPL-28 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 EXELON
NDA #020823		 SUPPL-29 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 EXELON
NDA #021025		 SUPPL-18 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 EXELON
NDA #021025		 SUPPL-19 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 EXELON
NDA #021025		 SUPPL-20 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
10/01/2013 KHEDEZLA
NDA #204683		 SUPPL-1 DESVENLAFAXINE OSMOTICA PHARM CORP Labeling Approval
10/02/2013 MODICON 28
NDA #017735		 SUPPL-108 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 MODICON 28
NDA #017735		 SUPPL-110 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 MODICON 28
NDA #017735		 SUPPL-114 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-90 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-92 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-96 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 7/7/7-21
NDA #018985		 SUPPL-54 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 7/7/7-21
NDA #018985		 SUPPL-56 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 7/7/7-21
NDA #018985		 SUPPL-60 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 7/7/7-28
NDA #018985		 SUPPL-54 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 7/7/7-28
NDA #018985		 SUPPL-56 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-NOVUM 7/7/7-28
NDA #018985		 SUPPL-60 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO CYCLEN-21
NDA #019653		 SUPPL-49 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO CYCLEN-21
NDA #019653		 SUPPL-51 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO CYCLEN-21
NDA #019653		 SUPPL-54 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO CYCLEN-28
NDA #019653		 SUPPL-49 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO CYCLEN-28
NDA #019653		 SUPPL-51 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO CYCLEN-28
NDA #019653		 SUPPL-54 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO TRI-CYCLEN
NDA #019697		 SUPPL-45 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO TRI-CYCLEN
NDA #019697		 SUPPL-47 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO TRI-CYCLEN
NDA #019697		 SUPPL-50 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-CEPT
NDA #020301		 SUPPL-28 DESOGESTREL; ETHINYL ESTRADIOL JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-CEPT
NDA #020301		 SUPPL-30 DESOGESTREL; ETHINYL ESTRADIOL JANSSEN PHARMS Labeling Approval
10/02/2013 ORTHO-CEPT
NDA #020301		 SUPPL-34 DESOGESTREL; ETHINYL ESTRADIOL JANSSEN PHARMS Labeling Approval
10/02/2013 VIMPAT
NDA #022254		 SUPPL-17 LACOSAMIDE UCB INC Manufacturing (CMC) Approval
10/02/2013 ABSTRAL
NDA #022510		 SUPPL-11 FENTANYL CITRATE SENTYNL THERAPS INC Manufacturing (CMC) Approval
10/02/2013 VPRIV
BLA #022575		 SUPPL-13 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
10/02/2013 STRIBILD
NDA #203100		 SUPPL-4 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
10/03/2013 MODICON 28
NDA #017735		 SUPPL-104 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/03/2013 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-86 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/03/2013 REVIA
NDA #018932		 SUPPL-17 NALTREXONE HYDROCHLORIDE TEVA WOMENS Labeling Approval
10/03/2013 ORTHO-NOVUM 7/7/7-21
NDA #018985		 SUPPL-50 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/03/2013 ORTHO-NOVUM 7/7/7-28
NDA #018985		 SUPPL-50 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
10/03/2013 ORTHO CYCLEN-21
NDA #019653		 SUPPL-46 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/03/2013 ORTHO CYCLEN-28
NDA #019653		 SUPPL-46 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/03/2013 ORTHO TRI-CYCLEN
NDA #019697		 SUPPL-42 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
10/03/2013 ZINECARD
NDA #020212		 SUPPL-16 DEXRAZOXANE HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
10/03/2013 ORTHO-CEPT
NDA #020301		 SUPPL-25 DESOGESTREL; ETHINYL ESTRADIOL JANSSEN PHARMS Labeling Approval
10/03/2013 RELPAX
NDA #021016		 SUPPL-21 ELETRIPTAN HYDROBROMIDE UPJOHN Labeling Approval
10/03/2013 RELPAX
NDA #021016		 SUPPL-23 ELETRIPTAN HYDROBROMIDE UPJOHN Labeling Approval
10/03/2013 RELPAX
NDA #021016		 SUPPL-24 ELETRIPTAN HYDROBROMIDE UPJOHN Labeling Approval
10/03/2013 RELPAX
NDA #021016		 SUPPL-27 ELETRIPTAN HYDROBROMIDE UPJOHN Labeling Approval
10/03/2013 SURFAXIN
NDA #021746		 SUPPL-3 LUCINACTANT LEES PHARM HK Manufacturing (CMC) Approval
10/03/2013 ACZONE
NDA #021794		 SUPPL-11 DAPSONE ALMIRALL Manufacturing (CMC) Approval
10/03/2013 DUAVEE
NDA #022247		 ORIG-1 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED WYETH PHARMS Type 1 - New Molecular Entity and Type 4 - New Combination Approval
10/03/2013 LYSTEDA
NDA #022430		 SUPPL-4 TRANEXAMIC ACID J MOLNER Labeling Approval
10/03/2013 TOPOTECAN HYDROCHLORIDE
NDA #022453		 SUPPL-1 TOPOTECAN HYDROCHLORIDE MEITHEAL Manufacturing (CMC) Approval
10/03/2013 KORLYM
NDA #202107		 SUPPL-2 MIFEPRISTONE CORCEPT THERAP Manufacturing (CMC) Approval
10/03/2013 POMALYST
NDA #204026		 SUPPL-1 POMALIDOMIDE BRISTOL Manufacturing (CMC) Approval
10/03/2013 CLINOLIPID 20%
NDA #204508		 ORIG-1 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Type 5 - New Formulation or New Manufacturer Approval
10/04/2013 NEXIUM
NDA #021153		 SUPPL-47 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Manufacturing (CMC) Approval
10/04/2013 NUVARING
NDA #021187		 SUPPL-21 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Efficacy Approval
10/04/2013 NUVARING
NDA #021187		 SUPPL-22 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Labeling Approval
10/04/2013 HEPSERA
NDA #021449		 SUPPL-21 ADEFOVIR DIPIVOXIL GILEAD Manufacturing (CMC) Approval
10/04/2013 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-4 LEVETIRACETAM HQ SPCLT PHARMA Manufacturing (CMC) Approval
10/07/2013 DEPO-MEDROL
NDA #011757		 SUPPL-97 METHYLPREDNISOLONE ACETATE PFIZER Manufacturing (CMC) Approval
10/07/2013 ADAGEN
BLA #019818		 SUPPL-47 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
10/07/2013 ALVESCO
NDA #021658		 SUPPL-7 CICLESONIDE AZURITY Manufacturing (CMC) Approval
10/07/2013 TOBRAMYCIN SULFATE
ANDA #065013		 SUPPL-10 TOBRAMYCIN SULFATE XGEN PHARMS Manufacturing (CMC) Approval
10/07/2013 ONDANSETRON
ANDA #077557		 SUPPL-7 ONDANSETRON SUN PHARM INDS Labeling Approval
10/07/2013 DESLORATADINE
ANDA #078359		 SUPPL-1 DESLORATADINE SUN PHARM INDS Labeling Approval
10/07/2013 XALKORI
NDA #202570		 SUPPL-7 CRIZOTINIB PF PRISM CV Labeling Approval
10/07/2013 XALKORI
NDA #202570		 SUPPL-9 CRIZOTINIB PF PRISM CV Labeling Approval
10/08/2013 PEDIAPRED
NDA #019157		 SUPPL-20 PREDNISOLONE SODIUM PHOSPHATE PAI HOLDINGS Labeling Approval
10/08/2013 PAREMYD
NDA #019261		 SUPPL-12 HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
10/08/2013 ACTIVELLA
NDA #020907		 SUPPL-13 ESTRADIOL; NORETHINDRONE ACETATE AMNEAL Labeling Approval
10/08/2013 VISUDYNE
NDA #021119		 SUPPL-25 VERTEPORFIN BAUSCH LOMB IRELAND Manufacturing (CMC) Approval
10/08/2013 FASLODEX
NDA #021344		 SUPPL-21 FULVESTRANT ASTRAZENECA Manufacturing (CMC) Approval
10/08/2013 FASLODEX
NDA #021344		 SUPPL-22 FULVESTRANT ASTRAZENECA Manufacturing (CMC) Approval
10/08/2013 OXYCODONE HYDROCHLORIDE
NDA #200535		 SUPPL-7 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Manufacturing (CMC) Approval
10/08/2013 PROCYSBI
NDA #203389		 SUPPL-1 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
10/08/2013 PHENYLEPHRINE HYDROCHLORIDE
NDA #203510		 SUPPL-1 PHENYLEPHRINE HYDROCHLORIDE PARAGON BIOTECK Manufacturing (CMC) Approval
10/08/2013 ADEMPAS
NDA #204819		 ORIG-1 RIOCIGUAT BAYER HLTHCARE Type 1 - New Molecular Entity Approval
10/09/2013 MORPHINE SULFATE (AUTOINJECTOR)
NDA #019999		 SUPPL-20 MORPHINE SULFATE MERIDIAN MEDCL TECHN Manufacturing (CMC) Approval
10/09/2013 CLIMARA
NDA #020375		 SUPPL-27 ESTRADIOL BAYER HLTHCARE Labeling Approval
10/09/2013 MENOSTAR
NDA #020375		 SUPPL-27 ESTRADIOL BAYER HLTHCARE Labeling Approval
10/09/2013 LOTEMAX
NDA #020583		 SUPPL-27 LOTEPREDNOL ETABONATE BAUSCH AND LOMB Manufacturing (CMC) Approval
10/09/2013 ALREX
NDA #020803		 SUPPL-25 LOTEPREDNOL ETABONATE BAUSCH AND LOMB Manufacturing (CMC) Approval
10/09/2013 ZYVOX
NDA #021132		 SUPPL-30 LINEZOLID PFIZER Manufacturing (CMC) Approval
10/09/2013 CLIMARA PRO
NDA #021258		 SUPPL-6 ESTRADIOL; LEVONORGESTREL BAYER HLTHCARE Labeling Approval
10/09/2013 VESICARE
NDA #021518		 SUPPL-16 SOLIFENACIN SUCCINATE ASTELLAS Labeling Approval
10/09/2013 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-26 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
10/09/2013 ZYLET
NDA #050804		 SUPPL-20 LOTEPREDNOL ETABONATE; TOBRAMYCIN BAUSCH AND LOMB Manufacturing (CMC) Approval
10/09/2013 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200245		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Approval
10/09/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #202464		 ORIG-1 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Approval
10/09/2013 TINIDAZOLE
ANDA #202489		 ORIG-1 TINIDAZOLE UNIQUE Approval
10/09/2013 TINIDAZOLE
ANDA #202489		 SUPPL-1 TINIDAZOLE UNIQUE Labeling Approval
10/10/2013 CLIMARA
NDA #020375		 SUPPL-28 ESTRADIOL BAYER HLTHCARE Labeling Approval
10/10/2013 MENOSTAR
NDA #020375		 SUPPL-28 ESTRADIOL BAYER HLTHCARE Labeling Approval
10/10/2013 AVAPRO
NDA #020757		 SUPPL-63 IRBESARTAN SANOFI AVENTIS US Manufacturing (CMC) Approval
10/10/2013 CHLORAPREP ONE-STEP
NDA #020832		 SUPPL-31 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Labeling Approval
10/10/2013 CHLORAPREP ONE-STEP FREPP
NDA #020832		 SUPPL-31 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Labeling Approval
10/10/2013 CHLORAPREP WITH TINT
NDA #020832		 SUPPL-31 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Labeling Approval
10/10/2013 AGGRASTAT
NDA #020912		 SUPPL-19 TIROFIBAN HYDROCHLORIDE MEDICURE Efficacy Approval
10/10/2013 AGGRASTAT
NDA #020912		 SUPPL-20 TIROFIBAN HYDROCHLORIDE MEDICURE Labeling Approval
10/10/2013 TEMODAR
NDA #021029		 SUPPL-25 TEMOZOLOMIDE MERCK SHARP DOHME Manufacturing (CMC) Approval
10/10/2013 RISPERDAL CONSTA
NDA #021346		 SUPPL-47 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
10/10/2013 CIALIS
NDA #021368		 SUPPL-22 TADALAFIL LILLY Efficacy Approval
10/10/2013 CHLORAPREP ONE-STEP SEPP
NDA #021555		 SUPPL-18 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Labeling Approval
10/10/2013 CHLORAPREP SINGLE SWABSTICK
NDA #021555		 SUPPL-18 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Labeling Approval
10/10/2013 CHLORAPREP TRIPLE SWABSTICK
NDA #021555		 SUPPL-18 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Labeling Approval
10/10/2013 DOXORUBICIN HYDROCHLORIDE
NDA #050467		 SUPPL-74 DOXORUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
10/10/2013 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-23 DOXORUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
10/10/2013 TOBRAMYCIN
ANDA #091589		 ORIG-1 TOBRAMYCIN TEVA PHARMS USA Approval
10/10/2013 KRYSTEXXA
BLA #125293		 SUPPL-60 PEGLOTICASE HORIZON PHARMA Approval
10/10/2013 ZIPRASIDONE HYDROCHLORIDE
ANDA #202395		 ORIG-1 ZIPRASIDONE HYDROCHLORIDE MYLAN Approval
10/11/2013 DEPO-MEDROL
NDA #011757		 SUPPL-98 METHYLPREDNISOLONE ACETATE PFIZER Manufacturing (CMC) Approval
10/11/2013 NICORETTE
NDA #018612		 SUPPL-69 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
10/11/2013 NICORETTE (MINT)
NDA #018612		 SUPPL-69 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
10/11/2013 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-35 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Efficacy Approval
10/11/2013 ZONEGRAN
NDA #020789		 SUPPL-32 ZONISAMIDE ADVANZ PHARMA Manufacturing (CMC) Approval
10/11/2013 COMTAN
NDA #020796		 SUPPL-22 ENTACAPONE ORION PHARMA Manufacturing (CMC) Approval
10/11/2013 FROVA
NDA #021006		 SUPPL-19 FROVATRIPTAN SUCCINATE ENDO OPERATIONS Labeling Approval
10/11/2013 SOMAVERT
BLA #021106		 SUPPL-43 PEGVISOMANT PHARMACIA Approval
10/11/2013 VIMPAT
NDA #022253		 SUPPL-25 LACOSAMIDE UCB INC Manufacturing (CMC) Approval
10/11/2013 MONODOX
NDA #050641		 SUPPL-27 DOXYCYCLINE CHARTWELL RX Labeling Approval
10/11/2013 ZMAX
NDA #050797		 SUPPL-13 AZITHROMYCIN PF PRISM CV Labeling Approval
10/11/2013 PENICILLIN V POTASSIUM
ANDA #090549		 ORIG-1 PENICILLIN V POTASSIUM HIKMA PHARMS Approval
10/11/2013 BUPROPION HYDROCHLORIDE
ANDA #202774		 ORIG-1 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Approval
10/11/2013 BUPROPION HYDROCHLORIDE
ANDA #202775		 ORIG-1 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Approval
10/11/2013 ACYCLOVIR SODIUM
ANDA #203701		 ORIG-1 ACYCLOVIR SODIUM EUGIA PHARMA Approval
10/11/2013 OTREXUP
NDA #204824		 ORIG-1 METHOTREXATE COSETTE Type 5 - New Formulation or New Manufacturer Approval
10/11/2013 OTREXUP
NDA #204824		 ORIG-2 METHOTREXATE COSETTE Efficacy Approval
10/11/2013 OTREXUP PFS
NDA #204824		 ORIG-1 METHOTREXATE COSETTE Type 5 - New Formulation or New Manufacturer Approval
10/11/2013 OTREXUP PFS
NDA #204824		 ORIG-2 METHOTREXATE COSETTE Efficacy Approval
10/11/2013 DESVENLAFAXINE
NDA #205208		 ORIG-1 DESVENLAFAXINE FUMARATE TEVA PHARMS USA Type 5 - New Formulation or New Manufacturer Approval
10/14/2013 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-61 CIPROFLOXACIN BAYER HLTHCARE Manufacturing (CMC) Approval
10/14/2013 NORDITROPIN
BLA #021148		 SUPPL-39 SOMATROPIN NOVO NORDISK INC Approval
10/14/2013 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-39 SOMATROPIN NOVO NORDISK INC Approval
10/14/2013 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-39 SOMATROPIN NOVO NORDISK INC Approval
10/15/2013 MICRONASE
NDA #017498		 SUPPL-31 GLYBURIDE PFIZER Labeling Approval
10/15/2013 DIABETA
NDA #017532		 SUPPL-34 GLYBURIDE SANOFI AVENTIS US Labeling Approval
10/15/2013 GLUCOTROL
NDA #017783		 SUPPL-25 GLIPIZIDE PFIZER Labeling Approval
10/15/2013 ADAGEN
BLA #019818		 SUPPL-48 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
10/15/2013 GLYNASE
NDA #020051		 SUPPL-20 GLYBURIDE PFIZER Labeling Approval
10/15/2013 GLUCOTROL XL
NDA #020329		 SUPPL-28 GLIPIZIDE PFIZER Labeling Approval
10/15/2013 AMARYL
NDA #020496		 SUPPL-27 GLIMEPIRIDE SANOFI AVENTIS US Labeling Approval
10/15/2013 ZOLOFT
NDA #020990		 SUPPL-42 SERTRALINE HYDROCHLORIDE VIATRIS Manufacturing (CMC) Approval
10/15/2013 GLUCOVANCE
NDA #021178		 SUPPL-15 GLYBURIDE; METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB Labeling Approval
10/15/2013 METAGLIP
NDA #021460		 SUPPL-10 GLIPIZIDE; METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB Labeling Approval
10/15/2013 PROCHLORPERAZINE EDISYLATE
ANDA #204147		 ORIG-1 PROCHLORPERAZINE EDISYLATE AVET LIFESCIENCES Approval
10/16/2013 AMERGE
NDA #020763		 SUPPL-1 NARATRIPTAN HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
10/16/2013 AMERGE
NDA #020763		 SUPPL-2 NARATRIPTAN HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
10/16/2013 AMERGE
NDA #020763		 SUPPL-10 NARATRIPTAN HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
10/16/2013 XENICAL
NDA #020766		 SUPPL-33 ORLISTAT CHEPLAPHARM Labeling Approval
10/16/2013 SYNERA
NDA #021623		 SUPPL-21 LIDOCAINE; TETRACAINE GALEN SPECIALTY Manufacturing (CMC) Approval
10/16/2013 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-36 FOLLITROPIN ALFA/BETA EMD SERONO Approval
10/16/2013 EOVIST
NDA #022090		 SUPPL-8 GADOXETATE DISODIUM BAYER HLTHCARE Labeling Approval
10/16/2013 EFFIENT
NDA #022307		 SUPPL-8 PRASUGREL HYDROCHLORIDE COSETTE Efficacy Approval
10/16/2013 LIVALO
NDA #022363		 SUPPL-12 PITAVASTATIN CALCIUM KOWA CO Labeling Approval
10/16/2013 STRIBILD
NDA #203100		 SUPPL-7 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
10/17/2013 MAGNEVIST
NDA #019596		 SUPPL-56 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
10/17/2013 GENOTROPIN
BLA #020280		 SUPPL-75 SOMATROPIN PHARMACIA Approval
10/17/2013 GENOTROPIN PRESERVATIVE FREE
BLA #020280		 SUPPL-75 SOMATROPIN PHARMACIA Approval
10/17/2013 LANOXIN
NDA #020405		 SUPPL-7 DIGOXIN ADVANZ PHARMA Labeling Approval
10/17/2013 MAGNEVIST
NDA #021037		 SUPPL-29 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
10/17/2013 ZEMPLAR
NDA #021606		 SUPPL-13 PARICALCITOL ABBVIE Manufacturing (CMC) Approval
10/17/2013 JANUVIA
NDA #021995		 SUPPL-28 SITAGLIPTIN PHOSPHATE MSD Manufacturing (CMC) Approval
10/17/2013 PRANDIMET
NDA #022386		 SUPPL-9 METFORMIN HYDROCHLORIDE; REPAGLINIDE NOVO NORDISK INC Manufacturing (CMC) Approval
10/17/2013 PRANDIMET
NDA #022386		 SUPPL-11 METFORMIN HYDROCHLORIDE; REPAGLINIDE NOVO NORDISK INC Manufacturing (CMC) Approval
10/17/2013 QSYMIA
NDA #022580		 SUPPL-7 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS LLC Manufacturing (CMC) Approval
10/17/2013 FLUPHENAZINE DECANOATE
ANDA #074531		 SUPPL-13 FLUPHENAZINE DECANOATE HIKMA Labeling Approval
10/17/2013 ACARBOSE
ANDA #091343		 ORIG-1 ACARBOSE SOMERSET THERAPS LLC Approval
10/17/2013 CIMZIA
BLA #125160		 SUPPL-215 CERTOLIZUMAB PEGOL UCB INC Approval
10/17/2013 LAMOTRIGINE
ANDA #200672		 ORIG-1 LAMOTRIGINE ACTAVIS ELIZABETH Approval
10/17/2013 JANUMET XR
NDA #202270		 SUPPL-5 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
10/17/2013 KAZANO
NDA #203414		 SUPPL-1 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
10/18/2013 BICNU
NDA #017422		 SUPPL-46 CARMUSTINE AVET LIFESCIENCES Labeling Approval
10/18/2013 ASACOL
NDA #019651		 SUPPL-24 MESALAMINE APIL Efficacy Approval
10/18/2013 CLARITIN-D
NDA #019670		 SUPPL-31 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
10/18/2013 FIORICET W/ CODEINE
NDA #020232		 SUPPL-36 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ACTAVIS LABS UT INC Labeling Approval
10/18/2013 INFASURF PRESERVATIVE FREE
BLA #020521		 SUPPL-26 CALFACTANT ONY Approval
10/18/2013 DUONEB
NDA #020950		 SUPPL-38 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE PHARMOBEDIENT Manufacturing (CMC) Approval
10/18/2013 LANTUS
BLA #021081		 SUPPL-57 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
10/18/2013 LANTUS SOLOSTAR
BLA #021081		 SUPPL-57 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
10/18/2013 TRI-LUMA
NDA #021112		 SUPPL-8 FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN GALDERMA LABS LP Manufacturing (CMC) Approval
10/18/2013 ULTRACET
NDA #021123		 SUPPL-8 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
10/18/2013 DIOVAN
NDA #021283		 SUPPL-40 VALSARTAN NOVARTIS Manufacturing (CMC) Approval
10/18/2013 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-9 FENOFIBRATE LUPIN Manufacturing (CMC) Approval
10/18/2013 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-11 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
10/18/2013 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
NDA #021704		 SUPPL-15 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
10/18/2013 ENTEREG
NDA #021775		 SUPPL-10 ALVIMOPAN CUBIST PHARMS Efficacy Approval
10/18/2013 ASACOL HD
NDA #021830		 SUPPL-6 MESALAMINE ABBVIE Efficacy Approval
10/18/2013 TYKERB
NDA #022059		 SUPPL-16 LAPATINIB DITOSYLATE NOVARTIS Efficacy Approval
10/18/2013 TYKERB
NDA #022059		 SUPPL-17 LAPATINIB DITOSYLATE NOVARTIS Efficacy Approval
10/18/2013 OFIRMEV
NDA #022450		 SUPPL-5 ACETAMINOPHEN MALLINCKRODT HOSP Labeling Approval
10/18/2013 OFIRMEV
NDA #022450		 SUPPL-6 ACETAMINOPHEN MALLINCKRODT HOSP Labeling Approval
10/18/2013 PRADAXA
NDA #022512		 SUPPL-19 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
10/18/2013 NORCO
ANDA #040099		 SUPPL-17 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040105		 SUPPL-15 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE PH HEALTH Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040148		 SUPPL-50 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
10/18/2013 NORCO
ANDA #040148		 SUPPL-50 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040171		 SUPPL-30 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WATSON LABS Labeling Approval
10/18/2013 PERCOCET
ANDA #040330		 SUPPL-35 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE OZANTRI Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #040387		 SUPPL-13 ACETAMINOPHEN; BUTALBITAL; CAFFEINE GENUS Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040419		 SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE SPECGX LLC Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040432		 SUPPL-6 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040482		 SUPPL-13 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #040511		 SUPPL-14 ACETAMINOPHEN; BUTALBITAL; CAFFEINE STRIDES PHARMA INTL Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040535		 SUPPL-29 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE WATSON LABS Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040545		 SUPPL-9 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #040601		 SUPPL-5 ACETAMINOPHEN; BUTALBITAL; CAFFEINE SUN PHARM INDUSTRIES Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040608		 SUPPL-8 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MIKART Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040658		 SUPPL-6 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040777		 SUPPL-8 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040778		 SUPPL-9 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMNEAL PHARMS NY Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040779		 SUPPL-12 ACETAMINOPHEN; CODEINE PHOSPHATE AMNEAL PHARMS NY Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040834		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE PHARM ASSOC Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040838		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE PHARM ASSOC Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040846		 SUPPL-5 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040881		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040894		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE GENUS Labeling Approval
10/18/2013 ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
ANDA #074699		 SUPPL-22 ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE WATSON LABS Labeling Approval
10/18/2013 PERCOCET
ANDA #085106		 SUPPL-23 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE OZANTRI Labeling Approval
10/18/2013 ROXICET
ANDA #087003		 SUPPL-35 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/18/2013 OXYCET
ANDA #087463		 SUPPL-36 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087508		 SUPPL-34 ACETAMINOPHEN; CODEINE PHOSPHATE GENUS LIFESCIENCES Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #087804		 SUPPL-39 ACETAMINOPHEN; BUTALBITAL; CAFFEINE SPECGX LLC Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-61 ACETAMINOPHEN; CODEINE PHOSPHATE ANI PHARMS Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #089007		 SUPPL-44 ACETAMINOPHEN; BUTALBITAL; CAFFEINE DR REDDYS LABS SA Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #089175		 SUPPL-45 ACETAMINOPHEN; BUTALBITAL; CAFFEINE MIKART Labeling Approval
10/18/2013 ROXICET
ANDA #089351		 SUPPL-26 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089450		 SUPPL-17 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089673		 SUPPL-22 ACETAMINOPHEN; CODEINE PHOSPHATE RHODES PHARMS Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089699		 SUPPL-44 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
10/18/2013 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #089718		 SUPPL-15 ACETAMINOPHEN; BUTALBITAL; CAFFEINE HIKMA PHARMS Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089805		 SUPPL-20 ACETAMINOPHEN; CODEINE PHOSPHATE STRIDES PHARMA INTL Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089828		 SUPPL-19 ACETAMINOPHEN; CODEINE PHOSPHATE STRIDES PHARMA INTL Labeling Approval
10/18/2013 BUTAPAP
ANDA #089987		 SUPPL-15 ACETAMINOPHEN; BUTALBITAL MIKART Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089990		 SUPPL-15 ACETAMINOPHEN; CODEINE PHOSPHATE STRIDES PHARMA INTL Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #090733		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE PH HEALTH Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #090734		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE PH HEALTH Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #091238		 SUPPL-7 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL MOLECULAR Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #200343		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE GENUS Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #201447		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #201972		 SUPPL-2 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
10/18/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #202214		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE TRIS PHARMA INC Labeling Approval
10/18/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #202677		 SUPPL-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ALVOGEN Labeling Approval
10/18/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #202800		 SUPPL-3 ACETAMINOPHEN; CODEINE PHOSPHATE AUROLIFE PHARMA LLC Labeling Approval
10/18/2013 PROCYSBI
NDA #203389		 SUPPL-2 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
10/18/2013 OPSUMIT
NDA #204410		 ORIG-1 MACITENTAN ACTELION Type 1 - New Molecular Entity Approval
10/18/2013 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
NDA #204505		 ORIG-1 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE AUROBINDO PHARMA LTD Type 4 - New Combination Tentative Approval
10/18/2013 ZORVOLEX
NDA #204592		 ORIG-1 DICLOFENAC ZYLA Type 3 - New Dosage Form Approval
10/21/2013 ZYPREXA
NDA #020592		 SUPPL-65 OLANZAPINE CHEPLAPHARM Manufacturing (CMC) Approval
10/21/2013 PENNSAID
NDA #020947		 SUPPL-8 DICLOFENAC SODIUM NUVO PHARMS INC Labeling Approval
10/21/2013 EXJADE
NDA #021882		 SUPPL-19 DEFERASIROX NOVARTIS Labeling Approval
10/21/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040223		 SUPPL-26 ACETAMINOPHEN; CODEINE PHOSPHATE DURAMED PHARMS BARR Labeling Approval
10/21/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040223		 SUPPL-27 ACETAMINOPHEN; CODEINE PHOSPHATE DURAMED PHARMS BARR Labeling Approval
10/21/2013 MEPERIDINE HYDROCHLORIDE
ANDA #040331		 SUPPL-14 MEPERIDINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
10/21/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #040680		 SUPPL-2 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
10/21/2013 SOLODYN
NDA #050808		 SUPPL-23 MINOCYCLINE HYDROCHLORIDE BAUSCH Labeling Approval
10/21/2013 ACTEMRA
BLA #125276		 SUPPL-92 TOCILIZUMAB GENENTECH Approval
10/21/2013 ACTEMRA
BLA #125472		 ORIG-1 TOCILIZUMAB GENENTECH Approval
10/21/2013 GADAVIST
NDA #201277		 SUPPL-3 GADOBUTROL BAYER HLTHCARE Labeling Approval
10/21/2013 AMLODIPINE BESYLATE
ANDA #203245		 ORIG-1 AMLODIPINE BESYLATE UNICHEM Approval
10/22/2013 VALIUM
NDA #013263		 SUPPL-92 DIAZEPAM WAYLIS THERAP Labeling Approval
10/22/2013 FRAGMIN
NDA #020287		 SUPPL-61 DALTEPARIN SODIUM PFIZER Manufacturing (CMC) Approval
10/22/2013 CEREBYX
NDA #020450		 SUPPL-24 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
10/22/2013 RISPERDAL CONSTA
NDA #021346		 SUPPL-50 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
10/22/2013 MIRALAX
NDA #022015		 SUPPL-17 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
10/22/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040119		 SUPPL-6 ACETAMINOPHEN; CODEINE PHOSPHATE PAI HOLDINGS Labeling Approval
10/22/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040355		 SUPPL-20 ACETAMINOPHEN; HYDROCODONE BITARTRATE STRIDES PHARMA INTL Labeling Approval
10/22/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040655		 SUPPL-13 ACETAMINOPHEN; HYDROCODONE BITARTRATE STRIDES PHARMA INTL Labeling Approval
10/22/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040656		 SUPPL-13 ACETAMINOPHEN; HYDROCODONE BITARTRATE STRIDES PHARMA INTL Labeling Approval
10/22/2013 DELZICOL
NDA #204412		 SUPPL-2 MESALAMINE ABBVIE Manufacturing (CMC) Approval
10/23/2013 LOVENOX
NDA #020164		 SUPPL-102 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
10/23/2013 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-102 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
10/23/2013 LAMISIL
NDA #020539		 SUPPL-24 TERBINAFINE HYDROCHLORIDE NOVARTIS Labeling Approval
10/23/2013 SUBOXONE
NDA #020733		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
10/23/2013 ZYRTEC-D 12 HOUR
NDA #021150		 SUPPL-10 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE KENVUE BRANDS Manufacturing (CMC) Approval
10/23/2013 VIREAD
NDA #021356		 SUPPL-48 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
10/23/2013 TRUVADA
NDA #021752		 SUPPL-42 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Labeling Approval
10/23/2013 ATRIPLA
NDA #021937		 SUPPL-31 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Labeling Approval
10/23/2013 LAMISIL
NDA #022071		 SUPPL-10 TERBINAFINE HYDROCHLORIDE NOVARTIS Labeling Approval
10/23/2013 VIREAD
NDA #022577		 SUPPL-6 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
10/23/2013 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-24 DOXORUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
10/23/2013 KINERET
BLA #103950		 SUPPL-5150 ANAKINRA BIOVITRUM AB Approval
10/23/2013 COMPLERA
NDA #202123		 SUPPL-15 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
10/23/2013 STRIBILD
NDA #203100		 SUPPL-9 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
10/24/2013 AMINOHIPPURATE SODIUM
NDA #005619		 SUPPL-24 AMINOHIPPURATE SODIUM MERCK Manufacturing (CMC) Approval
10/24/2013 XYLOCAINE
NDA #008816		 SUPPL-38 LIDOCAINE HYDROCHLORIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
10/24/2013 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018657		 SUPPL-32 METRONIDAZOLE BAXTER HLTHCARE Labeling Approval
10/24/2013 INNOPRAN XL
NDA #021438		 SUPPL-17 PROPRANOLOL HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
10/24/2013 NAMENDA
NDA #021487		 SUPPL-10 MEMANTINE HYDROCHLORIDE ABBVIE Labeling Approval
10/24/2013 NAMENDA
NDA #021487		 SUPPL-12 MEMANTINE HYDROCHLORIDE ABBVIE Labeling Approval
10/24/2013 NAMENDA
NDA #021487		 SUPPL-14 MEMANTINE HYDROCHLORIDE ABBVIE Labeling Approval
10/24/2013 NAMENDA
NDA #021627		 SUPPL-8 MEMANTINE HYDROCHLORIDE ALLERGAN Labeling Approval
10/24/2013 ISENTRESS
NDA #022145		 SUPPL-30 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
10/24/2013 ISENTRESS HD
NDA #022145		 SUPPL-30 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
10/24/2013 BIAXIN
NDA #050698		 SUPPL-34 CLARITHROMYCIN ABBVIE Manufacturing (CMC) Approval
10/24/2013 TOBI
NDA #050753		 SUPPL-15 TOBRAMYCIN VIATRIS Manufacturing (CMC) Approval
10/24/2013 HALAVEN
NDA #201532		 SUPPL-8 ERIBULIN MESYLATE EISAI INC Manufacturing (CMC) Approval
10/24/2013 ISENTRESS
NDA #203045		 SUPPL-8 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
10/24/2013 ECOZA
NDA #205175		 ORIG-1 ECONAZOLE NITRATE RESILIA PHARMS Type 3 - New Dosage Form Approval
10/25/2013 RITALIN
NDA #010187		 SUPPL-75 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
10/25/2013 RITALIN-SR
NDA #018029		 SUPPL-45 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
10/25/2013 CALAN
NDA #018817		 SUPPL-31 VERAPAMIL HYDROCHLORIDE PFIZER Labeling Approval
10/25/2013 ZOCOR
NDA #019766		 SUPPL-90 SIMVASTATIN ORGANON Labeling Approval
10/25/2013 ACCUPRIL
NDA #019885		 SUPPL-39 QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
10/25/2013 ALTACE
NDA #019901		 SUPPL-63 RAMIPRIL KING PHARMS LLC Labeling Approval
10/25/2013 ACCURETIC
NDA #020125		 SUPPL-17 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
10/25/2013 ZYPREXA
NDA #020592		 SUPPL-66 OLANZAPINE CHEPLAPHARM Manufacturing (CMC) Approval
10/25/2013 RITALIN LA
NDA #021284		 SUPPL-21 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
10/25/2013 VYTORIN
NDA #021687		 SUPPL-48 EZETIMIBE; SIMVASTATIN ORGANON Labeling Approval
10/25/2013 APRISO
NDA #022301		 SUPPL-4 MESALAMINE SALIX Manufacturing (CMC) Approval
10/25/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040400		 SUPPL-20 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/25/2013 ANEXSIA 7.5/325
ANDA #040405		 SUPPL-20 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/25/2013 ANEXSIA 5/325
ANDA #040409		 SUPPL-20 ACETAMINOPHEN; HYDROCODONE BITARTRATE SPECGX LLC Labeling Approval
10/25/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075817		 SUPPL-26 CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
10/25/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075817		 SUPPL-29 CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
10/25/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #090118		 SUPPL-13 ACETAMINOPHEN; HYDROCODONE BITARTRATE SUN PHARM INDS INC Labeling Approval
10/25/2013 ZALTRAP
BLA #125418		 SUPPL-20 ZIV-AFLIBERCEPT SANOFI AVENTIS US Approval
10/25/2013 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #201013		 SUPPL-3 ACETAMINOPHEN; HYDROCODONE BITARTRATE AUROLIFE PHARMA LLC Labeling Approval
10/25/2013 AMYVID
NDA #202008		 SUPPL-18 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
10/25/2013 RAYOS
NDA #202020		 SUPPL-4 PREDNISONE HORIZON Manufacturing (CMC) Approval
10/25/2013 JUVISYNC
NDA #202343		 SUPPL-8 SIMVASTATIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
10/25/2013 ZOHYDRO ER
NDA #202880		 ORIG-1 HYDROCODONE BITARTRATE RECRO GAINESVILLE Type 3 - New Dosage Form Approval
10/25/2013 VIZAMYL
NDA #203137		 ORIG-1 FLUTEMETAMOL F-18 GE HEALTHCARE Type 1 - New Molecular Entity Approval
10/26/2013 SABRIL
NDA #020427		 SUPPL-10 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/26/2013 SABRIL
NDA #020427		 SUPPL-11 VIGABATRIN LUNDBECK PHARMS LLC Efficacy Approval
10/26/2013 SABRIL
NDA #020427		 SUPPL-12 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/26/2013 SABRIL
NDA #022006		 SUPPL-11 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
10/26/2013 SABRIL
NDA #022006		 SUPPL-12 VIGABATRIN LUNDBECK PHARMS LLC Efficacy Approval
10/26/2013 SABRIL
NDA #022006		 SUPPL-13 VIGABATRIN LUNDBECK PHARMS LLC Efficacy Approval
10/28/2013 CALAN SR
NDA #019152		 SUPPL-38 VERAPAMIL HYDROCHLORIDE PFIZER Labeling Approval
10/28/2013 NICORETTE
NDA #021330		 SUPPL-16 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/28/2013 NICORETTE
NDA #022360		 SUPPL-7 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/28/2013 DICLOFENAC SODIUM
ANDA #200936		 ORIG-1 DICLOFENAC SODIUM AMNEAL Approval
10/28/2013 INCIVEK
NDA #201917		 SUPPL-10 TELAPREVIR VERTEX PHARMS Efficacy Approval
10/28/2013 INCIVEK
NDA #201917		 SUPPL-12 TELAPREVIR VERTEX PHARMS Labeling Approval
10/29/2013 XYLOCAINE
NDA #006488		 SUPPL-79 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/29/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-79 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/29/2013 NIZORAL
NDA #019927		 SUPPL-32 KETOCONAZOLE JANSSEN PHARMS Labeling Approval
10/29/2013 SEROQUEL
NDA #020639		 SUPPL-61 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
10/29/2013 DIOVAN
NDA #020665		 SUPPL-33 VALSARTAN NOVARTIS Labeling Approval
10/29/2013 LEXIVA
NDA #021548		 SUPPL-33 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Manufacturing (CMC) Approval
10/29/2013 SEROQUEL XR
NDA #022047		 SUPPL-34 QUETIAPINE FUMARATE CHEPLAPHARM Labeling Approval
10/29/2013 HORIZANT
NDA #022399		 SUPPL-9 GABAPENTIN ENACARBIL AZURITY Manufacturing (CMC) Approval
10/29/2013 NAFCILLIN SODIUM
ANDA #062732		 SUPPL-13 NAFCILLIN SODIUM SANDOZ Labeling Approval
10/29/2013 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #077857		 SUPPL-18 ENOXAPARIN SODIUM SANDOZ Labeling Approval
10/29/2013 NICOTINE POLACRILEX
ANDA #078546		 SUPPL-8 NICOTINE POLACRILEX PERRIGO R AND D Manufacturing (CMC) Approval
10/29/2013 ENOXAPARIN SODIUM
ANDA #078660		 SUPPL-11 ENOXAPARIN SODIUM SANDOZ INC Labeling Approval
10/29/2013 CLONIDINE HYDROCHLORIDE
ANDA #203167		 ORIG-1 CLONIDINE HYDROCHLORIDE XGEN PHARMS Approval
10/29/2013 LISINOPRIL
ANDA #203508		 ORIG-1 LISINOPRIL INVAGEN PHARMS Approval
10/29/2013 ACYCLOVIR
ANDA #203834		 ORIG-1 ACYCLOVIR HETERO LABS LTD V Approval
10/30/2013 EURAX
NDA #006927		 SUPPL-33 CROTAMITON JOURNEY Manufacturing (CMC) Approval
10/30/2013 NORINYL 1+50 28-DAY
NDA #016659		 SUPPL-137 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
10/30/2013 NICORETTE
NDA #018612		 SUPPL-68 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2013 NICORETTE (MINT)
NDA #018612		 SUPPL-68 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2013 LUPRON DEPOT
NDA #019943		 SUPPL-34 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
10/30/2013 LUPRON DEPOT
NDA #020011		 SUPPL-41 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
10/30/2013 NICORETTE
NDA #020066		 SUPPL-49 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2013 NICORETTE (MINT)
NDA #020066		 SUPPL-49 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2013 CEREZYME
BLA #020367		 SUPPL-89 IMIGLUCERASE GENZYME Approval
10/30/2013 LUPRON DEPOT
NDA #020708		 SUPPL-34 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
10/30/2013 GLEEVEC
NDA #021588		 SUPPL-39 IMATINIB MESYLATE NOVARTIS Labeling Approval
10/30/2013 ABRAXANE
NDA #021660		 SUPPL-38 PACLITAXEL BRISTOL-MYERS Labeling Approval
10/30/2013 NEXAVAR
NDA #021923		 SUPPL-15 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
10/30/2013 SAVELLA
NDA #022256		 SUPPL-14 MILNACIPRAN HYDROCHLORIDE ABBVIE Labeling Approval
10/30/2013 SAVELLA
NDA #022256		 SUPPL-15 MILNACIPRAN HYDROCHLORIDE ABBVIE Labeling Approval
10/30/2013 BRILINTA
NDA #022433		 SUPPL-9 TICAGRELOR ASTRAZENECA REMS Approval
10/30/2013 ZUPLENZ
NDA #022524		 SUPPL-2 ONDANSETRON AQUESTIVE Labeling Approval
10/30/2013 NALOXONE HYDROCHLORIDE
ANDA #072076		 SUPPL-17 NALOXONE HYDROCHLORIDE INTL MEDICATION Labeling Approval
10/30/2013 CHOLINE C-11
NDA #203155		 SUPPL-2 CHOLINE C-11 MCPRF Manufacturing (CMC) Approval
10/30/2013 LUPANETA PACK
NDA #203696		 SUPPL-1 LEUPROLIDE ACETATE; NORETHINDRONE ACETATE ABBVIE ENDOCRINE Labeling Approval
10/30/2013 MORPHINE SULFATE
NDA #204223		 ORIG-1 MORPHINE SULFATE FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Approval
10/31/2013 DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016683		 SUPPL-101 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/31/2013 KLONOPIN
NDA #017533		 SUPPL-53 CLONAZEPAM CHEPLAPHARM Labeling Approval
10/31/2013 LOPID
NDA #018422		 SUPPL-53 GEMFIBROZIL PFIZER PHARMS Labeling Approval
10/31/2013 NICODERM CQ
NDA #020165		 SUPPL-31 NICOTINE CHATTEM SANOFI Labeling Approval
10/31/2013 KLONOPIN RAPIDLY DISINTEGRATING
NDA #020813		 SUPPL-9 CLONAZEPAM ROCHE Labeling Approval
10/31/2013 NOVOLOG
BLA #020986		 SUPPL-61 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-61 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-61 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 NOVOLOG INNOLET
BLA #020986		 SUPPL-61 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 NOVOLOG PENFILL
BLA #020986		 SUPPL-61 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 FUZEON
NDA #021481		 SUPPL-27 ENFUVIRTIDE ROCHE Labeling Approval
10/31/2013 LEVEMIR
BLA #021536		 SUPPL-33 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-33 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-33 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 LEVEMIR INNOLET
BLA #021536		 SUPPL-33 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 LEVEMIR PENFILL
BLA #021536		 SUPPL-33 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
10/31/2013 ACZONE
NDA #021794		 SUPPL-10 DAPSONE ALMIRALL Manufacturing (CMC) Approval
10/31/2013 PREZISTA
NDA #021976		 SUPPL-32 DARUNAVIR JANSSEN PRODS Manufacturing (CMC) Approval
10/31/2013 NUCYNTA
NDA #022304		 SUPPL-14 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
10/31/2013 NUCYNTA
NDA #022304		 SUPPL-15 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC Labeling Approval
10/31/2013 DUEXIS
NDA #022519		 SUPPL-6 FAMOTIDINE; IBUPROFEN HORIZON Labeling Approval
10/31/2013 DOXORUBICIN HYDROCHLORIDE
NDA #050467		 SUPPL-73 DOXORUBICIN HYDROCHLORIDE PFIZER Labeling Approval
10/31/2013 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-22 DOXORUBICIN HYDROCHLORIDE PFIZER Labeling Approval
10/31/2013 E.E.S. 200
ANDA #061639		 SUPPL-32 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
10/31/2013 E.E.S. 400
ANDA #061639		 SUPPL-32 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
10/31/2013 E.E.S. 400
ANDA #061905		 SUPPL-49 ERYTHROMYCIN ETHYLSUCCINATE CARNEGIE Labeling Approval
10/31/2013 OMEPRAZOLE MAGNESIUM
ANDA #078878		 SUPPL-12 OMEPRAZOLE MAGNESIUM DR REDDYS LABS LTD Labeling Approval
10/31/2013 TOLTERODINE TARTRATE
ANDA #201486		 ORIG-1 TOLTERODINE TARTRATE AUROBINDO PHARMA USA Approval
10/31/2013 ELIQUIS
NDA #202155		 SUPPL-4 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
10/31/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #202274		 ORIG-1 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Approval
10/31/2013 VANCOMYCIN HYDROCHLORIDE
ANDA #202275		 ORIG-1 VANCOMYCIN HYDROCHLORIDE AVET LIFESCIENCES Approval
10/31/2013 PROCYSBI
NDA #203389		 SUPPL-3 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
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