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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 2014

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 October 13, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/01/2014 SARAFEM
NDA #021860		 SUPPL-10 FLUOXETINE HYDROCHLORIDE APIL Labeling Approval
12/01/2014 LIDOCAINE HYDROCHLORIDE VISCOUS
ANDA #040708		 SUPPL-6 LIDOCAINE HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
12/01/2014 LOVASTATIN
ANDA #075991		 SUPPL-17 LOVASTATIN CARLSBAD Labeling Approval
12/01/2014 BUPROPION HYDROCHLORIDE
ANDA #077415		 SUPPL-25 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #077627		 SUPPL-7 TOPIRAMATE GLENMARK PHARMS LTD Labeling Approval
12/01/2014 LOVASTATIN
ANDA #078296		 SUPPL-19 LOVASTATIN LUPIN Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #079153		 SUPPL-12 TOPIRAMATE TORRENT PHARMS Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #079153		 SUPPL-16 TOPIRAMATE TORRENT PHARMS Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #079162		 SUPPL-4 TOPIRAMATE INVAGEN PHARMS Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #079162		 SUPPL-5 TOPIRAMATE INVAGEN PHARMS Labeling Approval
12/01/2014 LIDOCAINE HYDROCHLORIDE VISCOUS
ANDA #086578		 SUPPL-39 LIDOCAINE HYDROCHLORIDE ACTAVIS MID ATLANTIC Labeling Approval
12/01/2014 LIDOCAINE HYDROCHLORIDE
ANDA #087872		 SUPPL-23 LIDOCAINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #090162		 SUPPL-5 TOPIRAMATE UNICHEM LABS LTD Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #090278		 SUPPL-6 TOPIRAMATE SUN PHARM Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #090278		 SUPPL-7 TOPIRAMATE SUN PHARM Labeling Approval
12/01/2014 TOPIRAMATE
ANDA #090278		 SUPPL-9 TOPIRAMATE SUN PHARM Labeling Approval
12/01/2014 GILDESS 24 FE
ANDA #090293		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE PH HEALTH Approval
12/01/2014 FERROUS FUMARATE
ANDA #090938		 ORIG-1 FERROUS FUMARATE BARR LABS Approval
12/01/2014 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #090938		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE BARR LABS Approval
12/01/2014 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #091234		 SUPPL-1 DESOGESTREL; ETHINYL ESTRADIOL NOVAST LABS Labeling Approval
12/01/2014 CICLOPIROX
ANDA #091595		 SUPPL-1 CICLOPIROX GLENMARK PHARMS Labeling Approval
12/01/2014 BIMATOPROST
ANDA #201894		 ORIG-1 BIMATOPROST APOTEX Approval
12/01/2014 BRISDELLE
NDA #204516		 SUPPL-3 PAROXETINE MESYLATE LEGACY Labeling Approval
12/02/2014 COUMADIN
NDA #009218		 SUPPL-114 WARFARIN SODIUM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
12/02/2014 ACEPHEN
NDA #018060		 SUPPL-67 ACETAMINOPHEN COSETTE Manufacturing (CMC) Approval
12/02/2014 CARDENE
NDA #019734		 SUPPL-24 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
12/02/2014 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-24 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
12/02/2014 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-24 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
12/02/2014 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-24 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
12/02/2014 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-24 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
12/02/2014 SUCRAID
BLA #020772		 SUPPL-17 SACROSIDASE QOL MEDCL Approval
12/02/2014 ACTONEL
NDA #020835		 SUPPL-46 RISEDRONATE SODIUM APIL Manufacturing (CMC) Approval
12/02/2014 ALLEGRA ALLERGY
NDA #020872		 SUPPL-33 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/02/2014 ALLEGRA HIVES
NDA #020872		 SUPPL-33 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/02/2014 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-33 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/02/2014 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-33 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/02/2014 TARGRETIN
NDA #021055		 SUPPL-9 BEXAROTENE BAUSCH Manufacturing (CMC) Approval
12/02/2014 NEXAVAR
NDA #021923		 SUPPL-17 SORAFENIB TOSYLATE BAYER HLTHCARE Manufacturing (CMC) Approval
12/02/2014 DUTOPROL
NDA #021956		 SUPPL-7 HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE CONCORDIA Manufacturing (CMC) Approval
12/02/2014 VPRIV
BLA #022575		 SUPPL-15 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
12/02/2014 OXACILLIN SODIUM
ANDA #061490		 SUPPL-33 OXACILLIN SODIUM SANDOZ Labeling Approval
12/02/2014 DOXYCYCLINE HYCLATE
ANDA #062500		 SUPPL-45 DOXYCYCLINE HYCLATE CHARTWELL Labeling Approval
12/02/2014 DOXYCYCLINE HYCLATE
ANDA #062505		 SUPPL-70 DOXYCYCLINE HYCLATE CHARTWELL Labeling Approval
12/02/2014 AMOXICILLIN
ANDA #065255		 SUPPL-9 AMOXICILLIN HIKMA Labeling Approval
12/02/2014 DOXYCYCLINE
ANDA #065285		 SUPPL-19 DOXYCYCLINE LANNETT CO INC Labeling Approval
12/02/2014 CEFAZOLIN SODIUM
ANDA #065306		 SUPPL-6 CEFAZOLIN SODIUM ACS DOBFAR Labeling Approval
12/02/2014 AMOXICILLIN
ANDA #065319		 SUPPL-1 AMOXICILLIN CHARTWELL RX Labeling Approval
12/02/2014 AMOXICILLIN
ANDA #065322		 SUPPL-18 AMOXICILLIN HIKMA Labeling Approval
12/02/2014 AMOXICILLIN
ANDA #065324		 SUPPL-6 AMOXICILLIN AUROBINDO PHARMA LTD Labeling Approval
12/02/2014 AMOXICILLIN
ANDA #065325		 SUPPL-16 AMOXICILLIN HIKMA Labeling Approval
12/02/2014 AMOXICILLIN
ANDA #065325		 SUPPL-17 AMOXICILLIN HIKMA Labeling Approval
12/02/2014 CEFTRIAXONE
ANDA #065465		 SUPPL-5 CEFTRIAXONE SODIUM BEDFORD Labeling Approval
12/02/2014 CEFTRIAXONE
ANDA #065475		 SUPPL-6 CEFTRIAXONE SODIUM BEDFORD Labeling Approval
12/02/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211		 SUPPL-2 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/02/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211		 SUPPL-3 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/02/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211		 SUPPL-4 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/02/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211		 SUPPL-5 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/02/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211		 SUPPL-6 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/02/2014 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211		 SUPPL-7 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/02/2014 DEXAMETHASONE ACETATE
ANDA #084315		 SUPPL-118 DEXAMETHASONE ACETATE WATSON LABS Labeling Approval
12/02/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087668		 SUPPL-25 DEXAMETHASONE SODIUM PHOSPHATE WATSON LABS Labeling Approval
12/02/2014 DEXAMETHASONE ACETATE
ANDA #087711		 SUPPL-28 DEXAMETHASONE ACETATE WATSON LABS TEVA Labeling Approval
12/02/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #089169		 SUPPL-20 DEXAMETHASONE SODIUM PHOSPHATE DR REDDYS Labeling Approval
12/02/2014 PANTOPRAZOLE SODIUM
ANDA #202052		 ORIG-1 PANTOPRAZOLE SODIUM ORBION PHARMS Approval
12/02/2014 DOCETAXEL
NDA #202356		 SUPPL-1 DOCETAXEL PFIZER LABS Manufacturing (CMC) Approval
12/02/2014 PROCYSBI
NDA #203389		 SUPPL-11 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
12/02/2014 METFORMIN HYDROCHLORIDE
ANDA #203769		 SUPPL-3 METFORMIN HYDROCHLORIDE SCIEGEN PHARMS Manufacturing (CMC) Approval
12/02/2014 BLOXIVERZ
NDA #204078		 SUPPL-6 NEOSTIGMINE METHYLSULFATE EXELA PHARMA Manufacturing (CMC) Approval
12/02/2014 DELZICOL
NDA #204412		 SUPPL-5 MESALAMINE ABBVIE Manufacturing (CMC) Approval
12/02/2014 KITABIS PAK
NDA #205433		 ORIG-1 TOBRAMYCIN PULMOFLOW INC Type 5 - New Formulation or New Manufacturer Approval
12/03/2014 PREMARIN
NDA #004782		 SUPPL-171 ESTROGENS, CONJUGATED WYETH PHARMS Labeling Approval
12/03/2014 SURVANTA
BLA #020032		 SUPPL-44 BERACTANT ABBVIE Approval
12/03/2014 QUIXIN
NDA #021199		 SUPPL-14 LEVOFLOXACIN SANTEN Labeling Approval
12/03/2014 IQUIX
NDA #021571		 SUPPL-6 LEVOFLOXACIN SANTEN Labeling Approval
12/03/2014 VIBATIV
NDA #022110		 SUPPL-11 TELAVANCIN HYDROCHLORIDE APOTEX Labeling Approval
12/03/2014 AZITHROMYCIN
ANDA #065211		 SUPPL-24 AZITHROMYCIN SANDOZ Manufacturing (CMC) Approval
12/03/2014 AZITHROMYCIN
ANDA #065212		 SUPPL-22 AZITHROMYCIN SANDOZ Manufacturing (CMC) Approval
12/03/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065331		 SUPPL-17 EPIRUBICIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
12/03/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065331		 SUPPL-22 EPIRUBICIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
12/03/2014 LEVOFLOXACIN
ANDA #076890		 SUPPL-4 LEVOFLOXACIN CHARTWELL MOLECULAR Labeling Approval
12/03/2014 LEVOFLOXACIN
ANDA #076890		 SUPPL-6 LEVOFLOXACIN CHARTWELL MOLECULAR Labeling Approval
12/03/2014 GLIMEPIRIDE
ANDA #091220		 SUPPL-2 GLIMEPIRIDE MICRO LABS Labeling Approval
12/03/2014 GLIMEPIRIDE
ANDA #091220		 SUPPL-3 GLIMEPIRIDE MICRO LABS Manufacturing (CMC) Approval
12/03/2014 BLINCYTO
BLA #125557		 ORIG-1 BLINATUMOMAB AMGEN Approval
12/03/2014 TECFIDERA
NDA #204063		 SUPPL-3 DIMETHYL FUMARATE BIOGEN Efficacy Approval
12/03/2014 TECFIDERA
NDA #204063		 SUPPL-8 DIMETHYL FUMARATE BIOGEN Labeling Approval
12/03/2014 TECFIDERA
NDA #204063		 SUPPL-10 DIMETHYL FUMARATE BIOGEN Labeling Approval
12/04/2014 PAMIDRONATE DISODIUM
NDA #021113		 SUPPL-17 PAMIDRONATE DISODIUM HIKMA Labeling Approval
12/04/2014 LASTACAFT
NDA #022134		 SUPPL-1 ALCAFTADINE ABBVIE Labeling Approval
12/04/2014 MOZOBIL
NDA #022311		 SUPPL-15 PLERIXAFOR GENZYME Labeling Approval
12/04/2014 ACUVAIL
NDA #022427		 SUPPL-5 KETOROLAC TROMETHAMINE ABBVIE Labeling Approval
12/04/2014 IDAMYCIN
NDA #050661		 SUPPL-14 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
12/04/2014 IDAMYCIN PFS
NDA #050734		 SUPPL-22 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
12/04/2014 IDARUBICIN HYDROCHLORIDE
NDA #050734		 SUPPL-22 IDARUBICIN HYDROCHLORIDE PFIZER Labeling Approval
12/04/2014 DULOXETINE HYDROCHLORIDE
ANDA #090723		 SUPPL-1 DULOXETINE HYDROCHLORIDE PHARMAZONE Labeling Approval
12/04/2014 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-6 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Labeling Approval
12/04/2014 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-7 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Labeling Approval
12/04/2014 JAKAFI
NDA #202192		 SUPPL-8 RUXOLITINIB PHOSPHATE INCYTE CORP Efficacy Approval
12/04/2014 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202353		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE CHARTWELL RX Approval
12/04/2014 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202353		 ORIG-2 PRAMIPEXOLE DIHYDROCHLORIDE CHARTWELL RX Tentative Approval
12/04/2014 VIZAMYL
NDA #203137		 SUPPL-2 FLUTEMETAMOL F-18 GE HEALTHCARE Labeling Approval
12/05/2014 CARDIOGEN-82
NDA #019414		 SUPPL-16 RUBIDIUM CHLORIDE RB-82 BRACCO Manufacturing (CMC) Approval
12/05/2014 KLARON
NDA #019931		 SUPPL-22 SULFACETAMIDE SODIUM BAUSCH Manufacturing (CMC) Approval
12/05/2014 NORITATE
NDA #020743		 SUPPL-12 METRONIDAZOLE BAUSCH Manufacturing (CMC) Approval
12/05/2014 TRICOR
NDA #021203		 SUPPL-5 FENOFIBRATE ABBVIE Labeling Approval
12/05/2014 EXPAREL
NDA #022496		 SUPPL-5 BUPIVACAINE PACIRA PHARMS INC Labeling Approval
12/05/2014 BENZAMYCIN
NDA #050557		 SUPPL-38 BENZOYL PEROXIDE; ERYTHROMYCIN VALEANT INTL Manufacturing (CMC) Approval
12/05/2014 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-25 DOXORUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
12/05/2014 BENZACLIN
NDA #050756		 SUPPL-44 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
12/05/2014 AMOXIL
ANDA #062216		 SUPPL-34 AMOXICILLIN US ANTIBIOTICS Labeling Approval
12/05/2014 AMOXIL
ANDA #062226		 SUPPL-35 AMOXICILLIN US ANTIBIOTICS Labeling Approval
12/05/2014 LAROTID
ANDA #062226		 SUPPL-35 AMOXICILLIN US ANTIBIOTICS Labeling Approval
12/05/2014 CAPTOPRIL
ANDA #074505		 SUPPL-27 CAPTOPRIL HIKMA Labeling Approval
12/05/2014 DICLOFENAC POTASSIUM
ANDA #075219		 SUPPL-13 DICLOFENAC POTASSIUM TEVA Labeling Approval
12/05/2014 MITOXANTRONE HYDROCHLORIDE
ANDA #076871		 SUPPL-9 MITOXANTRONE HYDROCHLORIDE HOSPIRA Labeling Approval
12/05/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-16 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/05/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-18 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/05/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-19 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/05/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076990		 SUPPL-20 FLUOXETINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/05/2014 CITALOPRAM HYDROBROMIDE
ANDA #077046		 SUPPL-17 CITALOPRAM HYDROBROMIDE APOTEX Labeling Approval
12/05/2014 PANTOPRAZOLE SODIUM
ANDA #077056		 SUPPL-12 PANTOPRAZOLE SODIUM TEVA Labeling Approval
12/05/2014 PANTOPRAZOLE SODIUM
ANDA #077056		 SUPPL-15 PANTOPRAZOLE SODIUM TEVA Labeling Approval
12/05/2014 PANTOPRAZOLE SODIUM
ANDA #090074		 SUPPL-11 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
12/05/2014 LAMOTRIGINE
ANDA #090401		 SUPPL-6 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/05/2014 LAMOTRIGINE
ANDA #090401		 SUPPL-7 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/05/2014 LAMOTRIGINE
ANDA #090401		 SUPPL-9 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/05/2014 LAMOTRIGINE
ANDA #090401		 SUPPL-10 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/05/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #090899		 SUPPL-13 VENLAFAXINE HYDROCHLORIDE TORRENT Labeling Approval
12/05/2014 ESZOPICLONE
ANDA #091166		 SUPPL-2 ESZOPICLONE GLENMARK PHARMS LTD Labeling Approval
12/05/2014 ESZOPICLONE
ANDA #091169		 SUPPL-2 ESZOPICLONE TEVA Labeling Approval
12/05/2014 CAPECITABINE
ANDA #091649		 SUPPL-2 CAPECITABINE TEVA PHARMS USA Labeling Approval
12/05/2014 PROLIA
BLA #125320		 SUPPL-160 DENOSUMAB AMGEN Approval
12/05/2014 XGEVA
BLA #125320		 SUPPL-160 DENOSUMAB AMGEN Approval
12/05/2014 HEPARIN SODIUM
NDA #201370		 SUPPL-9 HEPARIN SODIUM PFIZER Manufacturing (CMC) Approval
12/05/2014 HEPARIN SODIUM PRESERVATIVE FREE
NDA #201370		 SUPPL-9 HEPARIN SODIUM PFIZER Manufacturing (CMC) Approval
12/05/2014 ABILIFY MAINTENA KIT
NDA #202971		 SUPPL-3 ARIPIPRAZOLE OTSUKA PHARM CO LTD Efficacy Approval
12/05/2014 MINASTRIN 24 FE
NDA #203667		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
12/05/2014 METHOCARBAMOL
ANDA #204404		 ORIG-1 METHOCARBAMOL PHARMOBEDIENT Approval
12/05/2014 PHENTERMINE HYDROCHLORIDE
ANDA #205019		 ORIG-1 PHENTERMINE HYDROCHLORIDE NUVO PHARM Approval
12/06/2014 DICLOFENAC POTASSIUM
ANDA #075229		 SUPPL-16 DICLOFENAC POTASSIUM RUBICON RESEARCH Labeling Approval
12/06/2014 RAMIPRIL
ANDA #090697		 SUPPL-2 RAMIPRIL ZYDUS PHARMS USA INC Labeling Approval
12/06/2014 RAMIPRIL
ANDA #090697		 SUPPL-3 RAMIPRIL ZYDUS PHARMS USA INC Labeling Approval
12/07/2014 LAMOTRIGINE
ANDA #078310		 SUPPL-3 LAMOTRIGINE ZENNOVA Labeling Approval
12/08/2014 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
12/08/2014 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
12/08/2014 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
12/08/2014 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
12/08/2014 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
12/08/2014 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-56 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
12/08/2014 MIRENA
NDA #021225		 SUPPL-35 LEVONORGESTREL BAYER HLTHCARE Manufacturing (CMC) Approval
12/08/2014 CLOZAPINE
ANDA #074949		 SUPPL-64 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
12/08/2014 CLOZAPINE
ANDA #074949		 SUPPL-65 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
12/08/2014 CLOZAPINE
ANDA #076809		 SUPPL-27 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
12/08/2014 CLOZAPINE
ANDA #076809		 SUPPL-28 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076972		 SUPPL-5 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076972		 SUPPL-6 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076972		 SUPPL-7 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076974		 SUPPL-5 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076974		 SUPPL-6 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076974		 SUPPL-7 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
12/08/2014 OLANZAPINE
ANDA #077243		 SUPPL-1 OLANZAPINE BARR LABS INC Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077535		 SUPPL-12 ONDANSETRON HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077535		 SUPPL-13 ONDANSETRON HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077840		 SUPPL-4 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077840		 SUPPL-5 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
12/08/2014 ONDANSETRON
ANDA #078152		 SUPPL-8 ONDANSETRON GLENMARK PHARMS LTD Labeling Approval
12/08/2014 ONDANSETRON
ANDA #078152		 SUPPL-10 ONDANSETRON GLENMARK PHARMS LTD Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078287		 SUPPL-2 ONDANSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078287		 SUPPL-3 ONDANSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #078288		 SUPPL-2 ONDANSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #078288		 SUPPL-3 ONDANSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #078776		 SUPPL-5 ONDANSETRON HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/08/2014 ONDANSETRON HYDROCHLORIDE
ANDA #078776		 SUPPL-7 ONDANSETRON HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/08/2014 LAMOTRIGINE
ANDA #079099		 SUPPL-6 LAMOTRIGINE GLENMARK PHARMS LTD Labeling Approval
12/08/2014 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-6 DIVALPROEX SODIUM RISING Labeling Approval
12/08/2014 OLANZAPINE
ANDA #091434		 SUPPL-8 OLANZAPINE TORRENT PHARMS LTD Labeling Approval
12/08/2014 OLANZAPINE
ANDA #200221		 SUPPL-4 OLANZAPINE JUBILANT GENERICS Labeling Approval
12/08/2014 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #201095		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL AMNEAL PHARMS Approval
12/08/2014 OLANZAPINE
ANDA #202050		 SUPPL-3 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
12/08/2014 OLANZAPINE
ANDA #202050		 SUPPL-6 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
12/08/2014 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #202247		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Approval
12/08/2014 OLANZAPINE
ANDA #202287		 SUPPL-1 OLANZAPINE ORBION PHARMS Labeling Approval
12/08/2014 MARAVIROC
ANDA #203382		 ORIG-1 MARAVIROC SANDOZ INC Tentative Approval
12/09/2014 EXTRANEAL
NDA #021321		 SUPPL-28 ICODEXTRIN VANTIVE US HLTHCARE Labeling Approval
12/09/2014 PROPRANOLOL HYDROCHLORIDE
ANDA #071972		 SUPPL-29 PROPRANOLOL HYDROCHLORIDE IMPAX LABS INC Labeling Approval
12/09/2014 PROPRANOLOL HYDROCHLORIDE
ANDA #071976		 SUPPL-29 PROPRANOLOL HYDROCHLORIDE IMPAX LABS INC Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #078526		 SUPPL-7 LEVETIRACETAM ORBION PHARMS Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #078526		 SUPPL-9 LEVETIRACETAM ORBION PHARMS Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #078526		 SUPPL-10 LEVETIRACETAM ORBION PHARMS Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #078582		 SUPPL-5 LEVETIRACETAM STRIDES PHARMA Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #078582		 SUPPL-7 LEVETIRACETAM STRIDES PHARMA Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #078582		 SUPPL-9 LEVETIRACETAM STRIDES PHARMA Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #090484		 SUPPL-3 LEVETIRACETAM ORBION PHARMS Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #090484		 SUPPL-5 LEVETIRACETAM ORBION PHARMS Labeling Approval
12/09/2014 LEVETIRACETAM
ANDA #090484		 SUPPL-6 LEVETIRACETAM ORBION PHARMS Labeling Approval
12/09/2014 ONFI
NDA #202067		 SUPPL-3 CLOBAZAM LUNDBECK PHARMS LLC Labeling Approval
12/09/2014 ONFI
NDA #203993		 SUPPL-3 CLOBAZAM LUNDBECK PHARMS LLC Labeling Approval
12/10/2014 GEODON
NDA #020825		 SUPPL-53 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
12/10/2014 GEODON
NDA #020919		 SUPPL-40 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
12/10/2014 ADVAIR HFA
NDA #021254		 SUPPL-24 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
12/10/2014 FLOVENT HFA
NDA #021433		 SUPPL-26 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
12/10/2014 GEODON
NDA #021483		 SUPPL-13 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Approval
12/10/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070184		 SUPPL-66 METOCLOPRAMIDE HYDROCHLORIDE TEVA Labeling Approval
12/10/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #072801		 SUPPL-41 METOCLOPRAMIDE HYDROCHLORIDE TEVA Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #073484		 SUPPL-22 VALPROIC ACID BIONPHARMA Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #073484		 SUPPL-23 VALPROIC ACID BIONPHARMA Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #073484		 SUPPL-24 VALPROIC ACID BIONPHARMA Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #073484		 SUPPL-25 VALPROIC ACID BIONPHARMA Labeling Approval
12/10/2014 PANTOPRAZOLE SODIUM
ANDA #077058		 SUPPL-12 PANTOPRAZOLE SODIUM SUN PHARM Labeling Approval
12/10/2014 PANTOPRAZOLE SODIUM
ANDA #077058		 SUPPL-14 PANTOPRAZOLE SODIUM SUN PHARM Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #077105		 SUPPL-3 VALPROIC ACID PAI HOLDINGS Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #077105		 SUPPL-4 VALPROIC ACID PAI HOLDINGS Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #077105		 SUPPL-5 VALPROIC ACID PAI HOLDINGS Labeling Approval
12/10/2014 VALPROIC ACID
ANDA #077105		 SUPPL-6 VALPROIC ACID PAI HOLDINGS Labeling Approval
12/10/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077365		 SUPPL-7 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
12/10/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077365		 SUPPL-8 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
12/10/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077541		 SUPPL-7 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
12/10/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077541		 SUPPL-11 ONDANSETRON HYDROCHLORIDE HIKMA Labeling Approval
12/10/2014 ONDANSETRON
ANDA #078050		 SUPPL-12 ONDANSETRON SANDOZ Labeling Approval
12/10/2014 ONDANSETRON
ANDA #078050		 SUPPL-13 ONDANSETRON SANDOZ Labeling Approval
12/10/2014 CITALOPRAM HYDROBROMIDE
ANDA #078216		 SUPPL-22 CITALOPRAM HYDROBROMIDE TORRENT PHARMS Labeling Approval
12/10/2014 PANTOPRAZOLE SODIUM
ANDA #078281		 SUPPL-16 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #078947		 SUPPL-18 LAMOTRIGINE TORRENT PHARMS Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #078947		 SUPPL-21 LAMOTRIGINE TORRENT PHARMS Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #079132		 SUPPL-7 LAMOTRIGINE JUBILANT CADISTA Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #079132		 SUPPL-8 LAMOTRIGINE JUBILANT CADISTA Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #079132		 SUPPL-11 LAMOTRIGINE JUBILANT CADISTA Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #079132		 SUPPL-12 LAMOTRIGINE JUBILANT CADISTA Labeling Approval
12/10/2014 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #088616		 SUPPL-64 ACETAMINOPHEN; BUTALBITAL; CAFFEINE ACTAVIS LABS UT INC Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #090170		 SUPPL-6 LAMOTRIGINE UNICHEM LABS LTD Labeling Approval
12/10/2014 LAMOTRIGINE
ANDA #090170		 SUPPL-9 LAMOTRIGINE UNICHEM LABS LTD Labeling Approval
12/10/2014 PANTOPRAZOLE SODIUM
ANDA #090797		 SUPPL-9 PANTOPRAZOLE SODIUM ACTAVIS TOTOWA Labeling Approval
12/10/2014 PANTOPRAZOLE SODIUM
ANDA #090797		 SUPPL-10 PANTOPRAZOLE SODIUM ACTAVIS TOTOWA Labeling Approval
12/10/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #091272		 SUPPL-10 VENLAFAXINE HYDROCHLORIDE SUN PHARM Labeling Approval
12/10/2014 ESCITALOPRAM OXALATE
ANDA #202227		 SUPPL-2 ESCITALOPRAM OXALATE AMNEAL PHARMS Labeling Approval
12/10/2014 ZOLEDRONIC ACID
NDA #203231		 SUPPL-5 ZOLEDRONIC ACID INFORLIFE Labeling Approval
12/10/2014 ZOLEDRONIC ACID
NDA #203231		 SUPPL-6 ZOLEDRONIC ACID INFORLIFE Labeling Approval
12/10/2014 ZOLEDRONIC ACID
NDA #203231		 SUPPL-7 ZOLEDRONIC ACID INFORLIFE Labeling Approval
12/11/2014 CHILDREN'S MOTRIN
NDA #020516		 SUPPL-29 IBUPROFEN KENVUE BRANDS Labeling Approval
12/11/2014 MOTRIN IB
NDA #020516		 SUPPL-29 IBUPROFEN KENVUE BRANDS Labeling Approval
12/11/2014 SUBUTEX
NDA #020732		 SUPPL-10 BUPRENORPHINE HYDROCHLORIDE INDIVIOR Labeling Approval
12/11/2014 SUBOXONE
NDA #020733		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Labeling Approval
12/11/2014 OVIDREL
BLA #021149		 SUPPL-39 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
12/11/2014 ABRAXANE
NDA #021660		 SUPPL-40 PACLITAXEL BRISTOL-MYERS Labeling Approval
12/11/2014 BROMDAY
NDA #021664		 SUPPL-20 BROMFENAC SODIUM BAUSCH AND LOMB INC Manufacturing (CMC) Approval
12/11/2014 XIBROM
NDA #021664		 SUPPL-20 BROMFENAC SODIUM BAUSCH AND LOMB INC Manufacturing (CMC) Approval
12/11/2014 TWYNSTA
NDA #022401		 SUPPL-14 AMLODIPINE BESYLATE; TELMISARTAN BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
12/11/2014 CLEOCIN
ANDA #062644		 SUPPL-9 CLINDAMYCIN PALMITATE HYDROCHLORIDE PFIZER Labeling Approval
12/11/2014 DOXYCYCLINE
ANDA #065377		 SUPPL-6 DOXYCYCLINE CHARTWELL RX Labeling Approval
12/11/2014 DOXYCYCLINE
ANDA #065427		 SUPPL-4 DOXYCYCLINE CHARTWELL RX Labeling Approval
12/11/2014 DOXYCYCLINE
ANDA #065471		 SUPPL-1 DOXYCYCLINE SUN PHARM INDUSTRIES Labeling Approval
12/11/2014 NIFEDIPINE
ANDA #072556		 SUPPL-36 NIFEDIPINE ACTAVIS ELIZABETH Labeling Approval
12/11/2014 NIFEDIPINE
ANDA #072579		 SUPPL-35 NIFEDIPINE ACTAVIS ELIZABETH Labeling Approval
12/11/2014 GLYBURIDE
ANDA #074388		 SUPPL-35 GLYBURIDE TEVA Manufacturing (CMC) Approval
12/11/2014 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075624		 SUPPL-20 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE RISING Labeling Approval
12/11/2014 LISINOPRIL
ANDA #075743		 SUPPL-14 LISINOPRIL PRINSTON INC Labeling Approval
12/11/2014 LISINOPRIL
ANDA #075743		 SUPPL-15 LISINOPRIL PRINSTON INC Labeling Approval
12/11/2014 LISINOPRIL
ANDA #075743		 SUPPL-18 LISINOPRIL PRINSTON INC Labeling Approval
12/11/2014 LISINOPRIL
ANDA #075743		 SUPPL-19 LISINOPRIL PRINSTON INC Labeling Approval
12/11/2014 LISINOPRIL
ANDA #075743		 SUPPL-20 LISINOPRIL PRINSTON INC Labeling Approval
12/11/2014 LISINOPRIL
ANDA #075743		 SUPPL-22 LISINOPRIL PRINSTON INC Labeling Approval
12/11/2014 ATENOLOL
ANDA #078254		 SUPPL-2 ATENOLOL NORTHSTAR HLTHCARE Labeling Approval
12/11/2014 ATENOLOL
ANDA #078254		 SUPPL-3 ATENOLOL NORTHSTAR HLTHCARE Labeling Approval
12/11/2014 ATENOLOL
ANDA #078254		 SUPPL-4 ATENOLOL NORTHSTAR HLTHCARE Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078774		 SUPPL-5 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078774		 SUPPL-6 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078774		 SUPPL-7 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078774		 SUPPL-8 LEVETIRACETAM TARO Labeling Approval
12/11/2014 RANITIDINE HYDROCHLORIDE
ANDA #078884		 SUPPL-3 RANITIDINE HYDROCHLORIDE WOCKHARDT Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078960		 SUPPL-2 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078960		 SUPPL-3 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078960		 SUPPL-4 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LEVETIRACETAM
ANDA #078960		 SUPPL-5 LEVETIRACETAM TARO Labeling Approval
12/11/2014 LOSARTAN POTASSIUM
ANDA #091497		 SUPPL-3 LOSARTAN POTASSIUM PRINSTON INC Labeling Approval
12/11/2014 LOSARTAN POTASSIUM
ANDA #091497		 SUPPL-4 LOSARTAN POTASSIUM PRINSTON INC Labeling Approval
12/11/2014 NIFEDIPINE
ANDA #202644		 SUPPL-1 NIFEDIPINE HERITAGE PHARMA Labeling Approval
12/11/2014 NIFEDIPINE
ANDA #202644		 SUPPL-2 NIFEDIPINE HERITAGE PHARMA Labeling Approval
12/11/2014 LINZESS
NDA #202811		 SUPPL-1 LINACLOTIDE ABBVIE Manufacturing (CMC) Approval
12/11/2014 KALYDECO
NDA #203188		 SUPPL-13 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
12/11/2014 BLOXIVERZ
NDA #204078		 SUPPL-4 NEOSTIGMINE METHYLSULFATE EXELA PHARMA Labeling Approval
12/11/2014 ZUBSOLV
NDA #204242		 SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EDENBRIDGE PHARMS Manufacturing (CMC) Approval
12/11/2014 VARITHENA
NDA #205098		 SUPPL-4 POLIDOCANOL BOSTON SCITFC Manufacturing (CMC) Approval
12/12/2014 LOTENSIN
NDA #019851		 SUPPL-46 BENAZEPRIL HYDROCHLORIDE VALIDUS PHARMS Labeling Approval
12/12/2014 TYLENOL
NDA #019872		 SUPPL-41 ACETAMINOPHEN KENVUE BRANDS Labeling Approval
12/12/2014 LOTENSIN HCT
NDA #020033		 SUPPL-50 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Labeling Approval
12/12/2014 MICARDIS
NDA #020850		 SUPPL-38 TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
12/12/2014 MICARDIS HCT
NDA #021162		 SUPPL-37 HYDROCHLOROTHIAZIDE; TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
12/12/2014 ABILIFY
NDA #021436		 SUPPL-38 ARIPIPRAZOLE OTSUKA Efficacy Approval
12/12/2014 ABILIFY
NDA #021713		 SUPPL-30 ARIPIPRAZOLE OTSUKA Efficacy Approval
12/12/2014 ABILIFY
NDA #021729		 SUPPL-22 ARIPIPRAZOLE OTSUKA Efficacy Approval
12/12/2014 ABILIFY
NDA #021866		 SUPPL-23 ARIPIPRAZOLE OTSUKA Efficacy Approval
12/12/2014 TWYNSTA
NDA #022401		 SUPPL-16 AMLODIPINE BESYLATE; TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
12/12/2014 DOXORUBICIN HYDROCHLORIDE
ANDA #064140		 SUPPL-35 DOXORUBICIN HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
12/12/2014 ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ANDA #075794		 SUPPL-40 ACETAMINOPHEN; ASPIRIN; CAFFEINE PERRIGO Labeling Approval
12/12/2014 OMEPRAZOLE
ANDA #076048		 SUPPL-16 OMEPRAZOLE APOTEX Labeling Approval
12/12/2014 OMEPRAZOLE
ANDA #076048		 SUPPL-17 OMEPRAZOLE APOTEX Labeling Approval
12/12/2014 OLANZAPINE
ANDA #076534		 SUPPL-2 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
12/12/2014 OLANZAPINE
ANDA #076534		 SUPPL-3 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
12/12/2014 ESCITALOPRAM OXALATE
ANDA #076765		 SUPPL-4 ESCITALOPRAM OXALATE TEVA PHARMS USA Labeling Approval
12/12/2014 GABAPENTIN
ANDA #077242		 SUPPL-12 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
12/12/2014 GABAPENTIN
ANDA #077242		 SUPPL-16 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
12/12/2014 GABAPENTIN
ANDA #077525		 SUPPL-12 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
12/12/2014 GABAPENTIN
ANDA #077525		 SUPPL-17 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
12/12/2014 CARBOPLATIN
ANDA #077926		 SUPPL-4 CARBOPLATIN SUN PHARM Labeling Approval
12/12/2014 SERTRALINE HYDROCHLORIDE
ANDA #077977		 SUPPL-9 SERTRALINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/12/2014 SERTRALINE HYDROCHLORIDE
ANDA #077977		 SUPPL-10 SERTRALINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #078956		 SUPPL-11 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #078956		 SUPPL-15 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #078956		 SUPPL-16 LAMOTRIGINE AUROBINDO PHARMA Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #079204		 SUPPL-6 LAMOTRIGINE TARO Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #079204		 SUPPL-7 LAMOTRIGINE TARO Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #079204		 SUPPL-8 LAMOTRIGINE TARO Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #090607		 SUPPL-4 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #090607		 SUPPL-5 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #090607		 SUPPL-6 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/12/2014 LAMOTRIGINE
ANDA #090607		 SUPPL-7 LAMOTRIGINE ALEMBIC PHARMS LTD Labeling Approval
12/12/2014 CALCITRIOL
ANDA #091356		 ORIG-1 CALCITRIOL ONESOURCE SPECIALTY Approval
12/12/2014 DOXORUBICIN HYDROCHLORIDE
ANDA #091418		 SUPPL-1 DOXORUBICIN HYDROCHLORIDE SUN PHARM INDS Labeling Approval
12/12/2014 PULMOZYME
BLA #103532		 SUPPL-5175 DORNASE ALFA GENENTECH Approval
12/12/2014 CYRAMZA
BLA #125477		 SUPPL-7 RAMUCIRUMAB ELI LILLY AND CO Approval
12/12/2014 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #200174		 ORIG-1 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE PADAGIS ISRAEL Approval
12/12/2014 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #203263		 SUPPL-1 DOXORUBICIN HYDROCHLORIDE SUN PHARM Labeling Approval
12/12/2014 HETLIOZ
NDA #205677		 SUPPL-1 TASIMELTEON VANDA PHARMS INC Labeling Approval
12/13/2014 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #071017		 SUPPL-64 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
12/13/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071443		 SUPPL-29 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE MYLAN Labeling Approval
12/13/2014 METHADOSE
ANDA #074184		 SUPPL-16 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
12/13/2014 CLOZAPINE
ANDA #075417		 SUPPL-34 CLOZAPINE MYLAN Labeling Approval
12/13/2014 CLOZAPINE
ANDA #075417		 SUPPL-35 CLOZAPINE MYLAN Labeling Approval
12/13/2014 FAMOTIDINE
ANDA #075511		 SUPPL-18 FAMOTIDINE IVAX SUB TEVA PHARMS Labeling Approval
12/13/2014 TIZANIDINE HYDROCHLORIDE
ANDA #076354		 SUPPL-9 TIZANIDINE HYDROCHLORIDE RISING Labeling Approval
12/13/2014 TIZANIDINE HYDROCHLORIDE
ANDA #076354		 SUPPL-10 TIZANIDINE HYDROCHLORIDE RISING Labeling Approval
12/13/2014 MYORISAN
ANDA #076485		 SUPPL-4 ISOTRETINOIN UPSHER SMITH LABS Labeling Approval
12/13/2014 METHADONE HYDROCHLORIDE
ANDA #077142		 SUPPL-11 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
12/13/2014 BUPROPION HYDROCHLORIDE
ANDA #077284		 SUPPL-30 BUPROPION HYDROCHLORIDE PH HEALTH Labeling Approval
12/13/2014 ZOLPIDEM TARTRATE
ANDA #077884		 SUPPL-13 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
12/13/2014 ZOLPIDEM TARTRATE
ANDA #077884		 SUPPL-14 ZOLPIDEM TARTRATE APOTEX INC Labeling Approval
12/13/2014 ESCITALOPRAM OXALATE
ANDA #078169		 SUPPL-4 ESCITALOPRAM OXALATE CHARTWELL RX Labeling Approval
12/13/2014 LAMOTRIGINE
ANDA #078525		 SUPPL-8 LAMOTRIGINE TARO PHARM INDS Labeling Approval
12/13/2014 LAMOTRIGINE
ANDA #078525		 SUPPL-11 LAMOTRIGINE TARO PHARM INDS Labeling Approval
12/13/2014 LAMOTRIGINE
ANDA #078525		 SUPPL-13 LAMOTRIGINE TARO PHARM INDS Labeling Approval
12/13/2014 CARBIDOPA, LEVODOPA AND ENTACAPONE
ANDA #079085		 SUPPL-1 CARBIDOPA; ENTACAPONE; LEVODOPA SUN PHARM Labeling Approval
12/13/2014 PHRENILIN
ANDA #087811		 SUPPL-29 ACETAMINOPHEN; BUTALBITAL VALEANT Labeling Approval
12/13/2014 ACETAMINOPHEN
ANDA #090205		 SUPPL-2 ACETAMINOPHEN SUN PHARM INDS LTD Labeling Approval
12/13/2014 DULOXETINE HYDROCHLORIDE
ANDA #090783		 SUPPL-4 DULOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
12/13/2014 PANTOPRAZOLE SODIUM
ANDA #090807		 SUPPL-2 PANTOPRAZOLE SODIUM RUBICON RESEARCH Labeling Approval
12/13/2014 PANTOPRAZOLE SODIUM
ANDA #090807		 SUPPL-3 PANTOPRAZOLE SODIUM RUBICON RESEARCH Labeling Approval
12/13/2014 OMEPRAZOLE
ANDA #091352		 SUPPL-3 OMEPRAZOLE ZYDUS PHARMS USA INC Labeling Approval
12/13/2014 OMEPRAZOLE
ANDA #091352		 SUPPL-5 OMEPRAZOLE ZYDUS PHARMS USA INC Labeling Approval
12/13/2014 OMEPRAZOLE
ANDA #091352		 SUPPL-7 OMEPRAZOLE ZYDUS PHARMS USA INC Labeling Approval
12/13/2014 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-6 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
12/14/2014 KETOROLAC TROMETHAMINE
ANDA #074802		 SUPPL-38 KETOROLAC TROMETHAMINE HOSPIRA Labeling Approval
12/14/2014 DICLOFENAC SODIUM
ANDA #076201		 SUPPL-10 DICLOFENAC SODIUM DEXCEL LTD Labeling Approval
12/14/2014 TIZANIDINE HYDROCHLORIDE
ANDA #076416		 SUPPL-13 TIZANIDINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
12/14/2014 CATAFLAM
ANDA #076561		 SUPPL-8 DICLOFENAC POTASSIUM PANGEA Labeling Approval
12/14/2014 DICLOFENAC SODIUM
ANDA #077600		 SUPPL-2 DICLOFENAC SODIUM RUBICON RESEARCH Labeling Approval
12/14/2014 LAMOTRIGINE
ANDA #078134		 SUPPL-5 LAMOTRIGINE HIKMA PHARMS Labeling Approval
12/14/2014 LAMOTRIGINE
ANDA #078134		 SUPPL-6 LAMOTRIGINE HIKMA PHARMS Labeling Approval
12/14/2014 LAMOTRIGINE
ANDA #078134		 SUPPL-7 LAMOTRIGINE HIKMA PHARMS Labeling Approval
12/14/2014 FINASTERIDE
ANDA #078341		 SUPPL-12 FINASTERIDE AUROBINDO PHARMA Labeling Approval
12/14/2014 FINASTERIDE
ANDA #078371		 SUPPL-1 FINASTERIDE ACTAVIS TOTOWA Labeling Approval
12/14/2014 FINASTERIDE
ANDA #090060		 SUPPL-1 FINASTERIDE HETERO LABS LTD III Labeling Approval
12/14/2014 FINASTERIDE
ANDA #091643		 SUPPL-1 FINASTERIDE ACCORD HLTHCARE Labeling Approval
12/14/2014 FINASTERIDE
ANDA #203687		 SUPPL-1 FINASTERIDE AUROBINDO PHARMA LTD Labeling Approval
12/14/2014 NUVESSA
NDA #205223		 SUPPL-1 METRONIDAZOLE ALEMBIC THERAP Labeling Approval
12/15/2014 BREVITAL SODIUM
NDA #011559		 SUPPL-48 METHOHEXITAL SODIUM PH HEALTH Manufacturing (CMC) Approval
12/15/2014 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-73 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
12/15/2014 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-73 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
12/15/2014 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-73 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
12/15/2014 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-73 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
12/15/2014 INTRALIPID 10%
NDA #017643		 SUPPL-74 SOYBEAN OIL FRESENIUS Manufacturing (CMC) Approval
12/15/2014 TODAY
NDA #018683		 SUPPL-35 NONOXYNOL-9 MAYER LABS INC Manufacturing (CMC) Approval
12/15/2014 CYKLOKAPRON
NDA #019281		 SUPPL-33 TRANEXAMIC ACID PFIZER Manufacturing (CMC) Approval
12/15/2014 XOPENEX
NDA #020837		 SUPPL-42 LEVALBUTEROL HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
12/15/2014 TAMIFLU
NDA #021087		 SUPPL-67 OSELTAMIVIR PHOSPHATE ROCHE Manufacturing (CMC) Approval
12/15/2014 ABILIFY
NDA #021436		 SUPPL-39 ARIPIPRAZOLE OTSUKA Manufacturing (CMC) Approval
12/15/2014 FLUDEOXYGLUCOSE F18
NDA #021870		 SUPPL-9 FLUDEOXYGLUCOSE F-18 FEINSTEIN Manufacturing (CMC) Approval
12/15/2014 FIRMAGON
NDA #022201		 SUPPL-8 DEGARELIX ACETATE FERRING Manufacturing (CMC) Approval
12/15/2014 EXPAREL
NDA #022496		 SUPPL-10 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
12/15/2014 EGRIFTA
BLA #022505		 SUPPL-5 TESAMORELIN ACETATE THERATECHNOLOGIES Approval
12/15/2014 ELLENCE
NDA #050778		 SUPPL-21 EPIRUBICIN HYDROCHLORIDE PFIZER INC Labeling Approval
12/15/2014 FINASTERIDE
ANDA #077914		 SUPPL-9 FINASTERIDE ACTAVIS TOTOWA TEVA Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #077960		 SUPPL-6 VALPROIC ACID LANNETT CO INC Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #077960		 SUPPL-9 VALPROIC ACID LANNETT CO INC Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #077960		 SUPPL-10 VALPROIC ACID LANNETT CO INC Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #077960		 SUPPL-11 VALPROIC ACID LANNETT CO INC Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #077960		 SUPPL-12 VALPROIC ACID LANNETT CO INC Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #077960		 SUPPL-13 VALPROIC ACID LANNETT CO INC Labeling Approval
12/15/2014 VALPROATE SODIUM
ANDA #078523		 SUPPL-4 VALPROATE SODIUM HIKMA FARMACEUTICA Labeling Approval
12/15/2014 VALPROATE SODIUM
ANDA #078523		 SUPPL-5 VALPROATE SODIUM HIKMA FARMACEUTICA Labeling Approval
12/15/2014 VALPROATE SODIUM
ANDA #078523		 SUPPL-6 VALPROATE SODIUM HIKMA FARMACEUTICA Labeling Approval
12/15/2014 VALPROATE SODIUM
ANDA #078523		 SUPPL-7 VALPROATE SODIUM HIKMA FARMACEUTICA Labeling Approval
12/15/2014 FINASTERIDE
ANDA #090121		 SUPPL-7 FINASTERIDE ACCORD HLTHCARE Labeling Approval
12/15/2014 FINASTERIDE
ANDA #090507		 SUPPL-5 FINASTERIDE SUN PHARM Labeling Approval
12/15/2014 MYCOPHENOLATE MOFETIL
ANDA #090661		 ORIG-1 MYCOPHENOLATE MOFETIL JUBILANT CADISTA Approval
12/15/2014 MYCOPHENOLATE MOFETIL
ANDA #090762		 ORIG-1 MYCOPHENOLATE MOFETIL JUBILANT CADISTA Approval
12/15/2014 VALPROIC ACID
ANDA #091037		 SUPPL-1 VALPROIC ACID SUN PHARM INDS LTD Labeling Approval
12/15/2014 VALPROIC ACID
ANDA #091037		 SUPPL-2 VALPROIC ACID SUN PHARM INDS LTD Labeling Approval
12/15/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #201187		 ORIG-1 OXYMORPHONE HYDROCHLORIDE EPIC PHARMA LLC Approval
12/15/2014 JAKAFI
NDA #202192		 SUPPL-9 RUXOLITINIB PHOSPHATE INCYTE CORP Labeling Approval
12/15/2014 SIGNIFOR LAR KIT
NDA #203255		 ORIG-1 PASIREOTIDE PAMOATE RECORDATI RARE Type 5 - New Formulation or New Manufacturer Approval
12/15/2014 KERYDIN
NDA #204427		 SUPPL-2 TAVABOROLE ANACOR PHARMS INC Manufacturing (CMC) Approval
12/15/2014 ARGATROBAN IN 0.9% SODIUM CHLORIDE
NDA #206769		 ORIG-1 ARGATROBAN TEVA PHARMS USA Type 5 - New Formulation or New Manufacturer Approval
12/16/2014 WELLBUTRIN
NDA #018644		 SUPPL-48 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/16/2014 CHG SCRUB
NDA #019258		 SUPPL-20 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
12/16/2014 CIDA-STAT
NDA #019258		 SUPPL-20 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
12/16/2014 WELLBUTRIN SR
NDA #020358		 SUPPL-55 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/16/2014 DIASTAT
NDA #020648		 SUPPL-12 DIAZEPAM BAUSCH Labeling Approval
12/16/2014 DIASTAT ACUDIAL
NDA #020648		 SUPPL-12 DIAZEPAM BAUSCH Labeling Approval
12/16/2014 DICLEGIS
NDA #021876		 SUPPL-6 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Labeling Approval
12/16/2014 SOMATULINE DEPOT
NDA #022074		 SUPPL-11 LANREOTIDE ACETATE IPSEN PHARMA Efficacy Approval
12/16/2014 PRIMAXIN
NDA #050587		 SUPPL-76 CILASTATIN SODIUM; IMIPENEM MERCK Labeling Approval
12/16/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #071402		 SUPPL-5 METOCLOPRAMIDE HYDROCHLORIDE ANI PHARMS Labeling Approval
12/16/2014 IBUPROFEN
ANDA #074916		 SUPPL-47 IBUPROFEN P AND L Manufacturing (CMC) Approval
12/17/2014 EFFEXOR XR
NDA #020699		 SUPPL-91 VENLAFAXINE HYDROCHLORIDE UPJOHN Labeling Approval
12/17/2014 LOTRIMIN ULTRA
NDA #021307		 SUPPL-14 BUTENAFINE HYDROCHLORIDE BAYER HEALTHCARE LLC Efficacy Approval
12/17/2014 BONIVA
NDA #021455		 SUPPL-18 IBANDRONATE SODIUM HOFFMANN LA ROCHE Labeling Approval
12/17/2014 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #201998		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE CHARTWELL MOLECULAR Approval
12/17/2014 QNASL
NDA #202813		 SUPPL-7 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Efficacy Approval
12/17/2014 QNASL
NDA #202813		 SUPPL-9 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Efficacy Approval
12/17/2014 STRIBILD
NDA #203100		 SUPPL-11 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/17/2014 XTORO
NDA #206307		 ORIG-1 FINAFLOXACIN FONSECA BIOSCIENCES Type 1 - New Molecular Entity Approval
12/18/2014 TOPAMAX
NDA #020505		 SUPPL-55 TOPIRAMATE JANSSEN PHARMS Labeling Approval
12/18/2014 TOPAMAX
NDA #020844		 SUPPL-46 TOPIRAMATE JANSSEN PHARMS Labeling Approval
12/18/2014 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-46 TOPIRAMATE JANSSEN PHARMS Labeling Approval
12/18/2014 AFINITOR
NDA #022334		 SUPPL-27 EVEROLIMUS NOVARTIS Efficacy Approval
12/18/2014 BUPROPION HYDROCHLORIDE
ANDA #200695		 ORIG-1 BUPROPION HYDROCHLORIDE SUN PHARM Approval
12/18/2014 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #203573		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE PH HEALTH Approval
12/18/2014 FLUDEOXYGLUCOSE F18
ANDA #204264		 ORIG-1 FLUDEOXYGLUCOSE F-18 PHARMALOGIC Approval
12/18/2014 AMMONIA N 13
ANDA #204356		 ORIG-1 AMMONIA N-13 WISCONSIN Approval
12/18/2014 LAMIVUDINE
ANDA #205217		 ORIG-1 LAMIVUDINE LUPIN Approval
12/18/2014 MAGNESIUM SULFATE
ANDA #206039		 ORIG-1 MAGNESIUM SULFATE EXELA PHARMA Approval
12/19/2014 CLOZARIL
NDA #019758		 SUPPL-73 CLOZAPINE HERITAGE LIFE Labeling Approval
12/19/2014 PRILOSEC
NDA #019810		 SUPPL-101 OMEPRAZOLE ASTRAZENECA Labeling Approval
12/19/2014 ESTRADIOL
ANDA #020167		 ORIG-1 ESTRADIOL MYLAN PHARMS INC Approval
12/19/2014 PREVACID
NDA #020406		 SUPPL-81 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
12/19/2014 CAMPTOSAR
NDA #020571		 SUPPL-48 IRINOTECAN HYDROCHLORIDE PFIZER INC Labeling Approval
12/19/2014 ZYPREXA
NDA #020592		 SUPPL-62 OLANZAPINE CHEPLAPHARM Labeling Approval
12/19/2014 ACIPHEX
NDA #020973		 SUPPL-35 RABEPRAZOLE SODIUM WAYLIS THERAP Labeling Approval
12/19/2014 VENTOLIN HFA
NDA #020983		 SUPPL-32 ALBUTEROL SULFATE GLAXOSMITHKLINE Labeling Approval
12/19/2014 PROTONIX
NDA #020987		 SUPPL-49 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
12/19/2014 PROTONIX IV
NDA #020988		 SUPPL-52 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
12/19/2014 GANIRELIX ACETATE
NDA #021057		 SUPPL-10 GANIRELIX ACETATE ORGANON USA ORGANON Labeling Approval
12/19/2014 ZYPREXA ZYDIS
NDA #021086		 SUPPL-40 OLANZAPINE CHEPLAPHARM Labeling Approval
12/19/2014 CUTIVATE
NDA #021152		 SUPPL-3 FLUTICASONE PROPIONATE FOUGERA Manufacturing (CMC) Approval
12/19/2014 NEXIUM
NDA #021153		 SUPPL-50 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
12/19/2014 ZYPREXA
NDA #021253		 SUPPL-48 OLANZAPINE CHEPLAPHARM Labeling Approval
12/19/2014 PREVACID
NDA #021428		 SUPPL-28 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
12/19/2014 SYMBYAX
NDA #021520		 SUPPL-34 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
12/19/2014 ZEGERID
NDA #021636		 SUPPL-16 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
12/19/2014 NEXIUM IV
NDA #021689		 SUPPL-30 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
12/19/2014 ZEGERID
NDA #021849		 SUPPL-10 OMEPRAZOLE; SODIUM BICARBONATE SALIX Labeling Approval
12/19/2014 SUTENT
NDA #021938		 SUPPL-27 SUNITINIB MALATE CPPI CV Labeling Approval
12/19/2014 NEXIUM
NDA #021957		 SUPPL-17 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
12/19/2014 PROTONIX
NDA #022020		 SUPPL-11 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
12/19/2014 PRILOSEC
NDA #022056		 SUPPL-17 OMEPRAZOLE MAGNESIUM AZURITY Labeling Approval
12/19/2014 NEXIUM
NDA #022101		 SUPPL-14 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
12/19/2014 ZYPREXA RELPREVV
NDA #022173		 SUPPL-15 OLANZAPINE PAMOATE CHEPLAPHARM Labeling Approval
12/19/2014 DEXILANT
NDA #022287		 SUPPL-19 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
12/19/2014 XARELTO
NDA #022406		 SUPPL-15 RIVAROXABAN JANSSEN PHARMS Labeling Approval
12/19/2014 VIMOVO
NDA #022511		 SUPPL-17 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
12/19/2014 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040148		 SUPPL-53 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
12/19/2014 NORCO
ANDA #040148		 SUPPL-53 ACETAMINOPHEN; HYDROCODONE BITARTRATE APIL Labeling Approval
12/19/2014 METHADONE HYDROCHLORIDE
ANDA #040241		 SUPPL-9 METHADONE HYDROCHLORIDE VISTAPHARM LLC Labeling Approval
12/19/2014 MERREM IV
NDA #050706		 SUPPL-35 MEROPENEM PFIZER Labeling Approval
12/19/2014 PREVPAC (COPACKAGED)
NDA #050757		 SUPPL-19 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
12/19/2014 DORYX
NDA #050795		 SUPPL-19 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
12/19/2014 DORYX MPC
NDA #050795		 SUPPL-19 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
12/19/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065445		 SUPPL-4 EPIRUBICIN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
12/19/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065445		 SUPPL-5 EPIRUBICIN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
12/19/2014 BETAXOLOL HYDROCHLORIDE
ANDA #075541		 SUPPL-10 BETAXOLOL HYDROCHLORIDE EPIC PHARMA Labeling Approval
12/19/2014 LISINOPRIL
ANDA #076164		 SUPPL-12 LISINOPRIL PRINSTON INC Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076252		 SUPPL-8 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076252		 SUPPL-9 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
12/19/2014 TRI-PREVIFEM
ANDA #076335		 SUPPL-17 ETHINYL ESTRADIOL; NORGESTIMATE PH HEALTH Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076759		 SUPPL-15 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076876		 SUPPL-12 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076876		 SUPPL-14 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-6 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-7 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-8 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
12/19/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-9 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
12/19/2014 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528		 SUPPL-3 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
12/19/2014 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528		 SUPPL-4 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
12/19/2014 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528		 SUPPL-5 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
12/19/2014 OXCARBAZEPINE
ANDA #077747		 SUPPL-7 OXCARBAZEPINE RUBICON RESEARCH Labeling Approval
12/19/2014 OXCARBAZEPINE
ANDA #077747		 SUPPL-9 OXCARBAZEPINE RUBICON RESEARCH Labeling Approval
12/19/2014 BETAXOLOL HYDROCHLORIDE
ANDA #078962		 SUPPL-1 BETAXOLOL HYDROCHLORIDE KVK TECH Labeling Approval
12/19/2014 MONO-LINYAH
ANDA #090523		 SUPPL-1 ETHINYL ESTRADIOL; NORGESTIMATE NOVAST LABS LTD Manufacturing (CMC) Approval
12/19/2014 BUPROPION HYDROCHLORIDE
ANDA #090942		 SUPPL-10 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/19/2014 SIMPONI
BLA #125289		 SUPPL-121 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
12/19/2014 GRANIX
BLA #125294		 SUPPL-35 TBO-FILGRASTIM SICOR BIOTECH Approval
12/19/2014 SIMPONI ARIA
BLA #125433		 SUPPL-13 GOLIMUMAB JANSSEN BIOTECH Approval
12/19/2014 TRULICITY
BLA #125469		 SUPPL-2 DULAGLUTIDE ELI LILLY AND CO Approval
12/19/2014 HALAVEN
NDA #201532		 SUPPL-10 ERIBULIN MESYLATE EISAI INC Labeling Approval
12/19/2014 ESTRADIOL
ANDA #201675		 ORIG-1 ESTRADIOL MYLAN TECHNOLOGIES Approval
12/19/2014 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074		 SUPPL-1 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
12/19/2014 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074		 SUPPL-2 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
12/19/2014 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074		 SUPPL-3 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
12/19/2014 ESOMEPRAZOLE STRONTIUM
NDA #202342		 SUPPL-2 ESOMEPRAZOLE STRONTIUM BELCHER Labeling Approval
12/19/2014 ACETAZOLAMIDE SODIUM
ANDA #202693		 ORIG-1 ACETAZOLAMIDE SODIUM AVET LIFESCIENCES Approval
12/19/2014 ACIPHEX SPRINKLE
NDA #204736		 SUPPL-5 RABEPRAZOLE SODIUM AYTU Labeling Approval
12/19/2014 TIVICAY
NDA #204790		 SUPPL-2 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
12/19/2014 LYNPARZA
NDA #206162		 ORIG-1 OLAPARIB ASTRAZENECA Type 1 - New Molecular Entity Approval
12/19/2014 SOOLANTRA
NDA #206255		 ORIG-1 IVERMECTIN GALDERMA LABS LP Type 3 - New Dosage Form Approval
12/19/2014 RAPIVAB
NDA #206426		 ORIG-1 PERAMIVIR BIOCRYST Type 1 - New Molecular Entity Approval
12/19/2014 VIEKIRA PAK (COPACKAGED)
NDA #206619		 ORIG-1 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Type 1 - New Molecular Entity and Type 4 - New Combination Approval
12/19/2014 ZERBAXA
NDA #206829		 ORIG-1 CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM CUBIST PHARMS LLC Type 1 - New Molecular Entity and Type 4 - New Combination Approval
12/20/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065361		 SUPPL-2 EPIRUBICIN HYDROCHLORIDE CIPLA LTD Labeling Approval
12/20/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065361		 SUPPL-4 EPIRUBICIN HYDROCHLORIDE CIPLA LTD Labeling Approval
12/20/2014 EPIRUBICIN HYDROCHLORIDE
ANDA #065361		 SUPPL-5 EPIRUBICIN HYDROCHLORIDE CIPLA LTD Labeling Approval
12/20/2014 OLANZAPINE
ANDA #076133		 SUPPL-2 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
12/20/2014 OLANZAPINE
ANDA #076133		 SUPPL-3 OLANZAPINE DR REDDYS LABS LTD Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076183		 SUPPL-5 ONDANSETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076183		 SUPPL-6 ONDANSETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076780		 SUPPL-15 ONDANSETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076780		 SUPPL-16 ONDANSETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076781		 SUPPL-11 ONDANSETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE
ANDA #076781		 SUPPL-12 ONDANSETRON HYDROCHLORIDE HIKMA FARMACEUTICA Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077009		 SUPPL-6 ONDANSETRON HYDROCHLORIDE TARO Labeling Approval
12/20/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077009		 SUPPL-7 ONDANSETRON HYDROCHLORIDE TARO Labeling Approval
12/20/2014 BUPROPION HYDROCHLORIDE
ANDA #077715		 SUPPL-31 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
12/21/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #065061		 SUPPL-24 CLINDAMYCIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
12/21/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #065242		 SUPPL-15 CLINDAMYCIN HYDROCHLORIDE LANNETT Labeling Approval
12/21/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #065243		 SUPPL-2 CLINDAMYCIN HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
12/21/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #065243		 SUPPL-11 CLINDAMYCIN HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
12/21/2014 ESTRADIOL
ANDA #075182		 SUPPL-28 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
12/21/2014 PAROXETINE HYDROCHLORIDE
ANDA #075356		 SUPPL-36 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
12/21/2014 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-19 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
12/21/2014 FAMOTIDINE
ANDA #075611		 SUPPL-8 FAMOTIDINE APOTEX Labeling Approval
12/21/2014 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-14 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
12/21/2014 PAROXETINE HYDROCHLORIDE
ANDA #076618		 SUPPL-20 PAROXETINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
12/21/2014 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #076899		 SUPPL-13 SULFAMETHOXAZOLE; TRIMETHOPRIM AMNEAL PHARMS NY Labeling Approval
12/21/2014 FENTANYL-100
ANDA #077062		 SUPPL-25 FENTANYL MAYNE PHARMA Labeling Approval
12/21/2014 FENTANYL-25
ANDA #077062		 SUPPL-25 FENTANYL MAYNE PHARMA Labeling Approval
12/21/2014 FENTANYL-50
ANDA #077062		 SUPPL-25 FENTANYL MAYNE PHARMA Labeling Approval
12/21/2014 FENTANYL-75
ANDA #077062		 SUPPL-25 FENTANYL MAYNE PHARMA Labeling Approval
12/21/2014 PANTOPRAZOLE SODIUM
ANDA #077619		 SUPPL-8 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
12/21/2014 PANTOPRAZOLE SODIUM
ANDA #077619		 SUPPL-9 PANTOPRAZOLE SODIUM DR REDDYS LABS LTD Labeling Approval
12/21/2014 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #078060		 SUPPL-16 SULFAMETHOXAZOLE; TRIMETHOPRIM CHARTWELL MOLECULES Labeling Approval
12/21/2014 ZOLPIDEM TARTRATE
ANDA #078179		 SUPPL-9 ZOLPIDEM TARTRATE ACTAVIS ELIZABETH Labeling Approval
12/21/2014 AMIODARONE HYDROCHLORIDE
ANDA #078578		 SUPPL-1 AMIODARONE HYDROCHLORIDE RUBICON RESEARCH Labeling Approval
12/21/2014 AMIODARONE HYDROCHLORIDE
ANDA #078578		 SUPPL-2 AMIODARONE HYDROCHLORIDE RUBICON RESEARCH Labeling Approval
12/21/2014 AMIODARONE HYDROCHLORIDE
ANDA #078578		 SUPPL-3 AMIODARONE HYDROCHLORIDE RUBICON RESEARCH Labeling Approval
12/21/2014 IMIPRAMINE PAMOATE
ANDA #090444		 SUPPL-3 IMIPRAMINE PAMOATE LUPIN LTD Labeling Approval
12/21/2014 IMIPRAMINE PAMOATE
ANDA #090444		 SUPPL-5 IMIPRAMINE PAMOATE LUPIN LTD Labeling Approval
12/21/2014 ONDANSETRON
ANDA #090469		 SUPPL-7 ONDANSETRON AUROBINDO PHARMA Labeling Approval
12/21/2014 ONDANSETRON
ANDA #090469		 SUPPL-8 ONDANSETRON AUROBINDO PHARMA Labeling Approval
12/21/2014 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #090624		 SUPPL-5 SULFAMETHOXAZOLE; TRIMETHOPRIM AUROBINDO PHARMA Labeling Approval
12/21/2014 PANTOPRAZOLE SODIUM
ANDA #090901		 SUPPL-8 PANTOPRAZOLE SODIUM JUBILANT GENERICS Labeling Approval
12/21/2014 PANTOPRAZOLE SODIUM
ANDA #090901		 SUPPL-9 PANTOPRAZOLE SODIUM JUBILANT GENERICS Labeling Approval
12/21/2014 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #203263		 SUPPL-3 DOXORUBICIN HYDROCHLORIDE SUN PHARM Labeling Approval
12/22/2014 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016673		 SUPPL-147 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016677		 SUPPL-148 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #016694		 SUPPL-119 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017385		 SUPPL-60 DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 20% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-68 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 30% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-68 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 40% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-68 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-68 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-68 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-68 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-69 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-69 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-69 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-69 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018016		 SUPPL-62 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 CORDARONE
NDA #018972		 SUPPL-50 AMIODARONE HYDROCHLORIDE WYETH PHARMS Labeling Approval
12/22/2014 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019022		 SUPPL-26 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019022		 SUPPL-26 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-20 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-20 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-20 DEXTROSE BAXTER HLTHCARE Labeling Approval
12/22/2014 REMODULIN
NDA #021272		 SUPPL-19 TREPROSTINIL UNITED THERAP Manufacturing (CMC) Approval
12/22/2014 TYKERB
NDA #022059		 SUPPL-21 LAPATINIB DITOSYLATE NOVARTIS Labeling Approval
12/22/2014 SOMATULINE DEPOT
NDA #022074		 SUPPL-10 LANREOTIDE ACETATE IPSEN PHARMA Labeling Approval
12/22/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072052		 SUPPL-8 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE HERITAGE PHARMA Labeling Approval
12/22/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072053		 SUPPL-8 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE HERITAGE PHARMA Labeling Approval
12/22/2014 OFLOXACIN
ANDA #076093		 SUPPL-6 OFLOXACIN CHARTWELL RX Labeling Approval
12/22/2014 LISINOPRIL
ANDA #078402		 SUPPL-1 LISINOPRIL WOCKHARDT BIO AG Labeling Approval
12/22/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #088348		 SUPPL-49 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
12/22/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #088349		 SUPPL-47 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
12/22/2014 METFORMIN HYDROCHLORIDE
ANDA #090888		 SUPPL-1 METFORMIN HYDROCHLORIDE PHARMAZONE Manufacturing (CMC) Approval
12/22/2014 ESZOPICLONE
ANDA #091169		 SUPPL-1 ESZOPICLONE TEVA Manufacturing (CMC) Approval
12/22/2014 OPDIVO
BLA #125554		 ORIG-1 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
12/22/2014 POKONZA
NDA #206814		 ORIG-1 POTASSIUM CHLORIDE GENUS LIFESCIENCES Type 7 - Drug Already Marketed without Approved NDA Approval
12/22/2014 POTASSIUM CHLORIDE
NDA #206814		 ORIG-1 POTASSIUM CHLORIDE GENUS LIFESCIENCES Type 7 - Drug Already Marketed without Approved NDA Approval
12/23/2014 RETROVIR
NDA #019655		 SUPPL-54 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
12/23/2014 TYLENOL
NDA #019872		 SUPPL-42 ACETAMINOPHEN KENVUE BRANDS Labeling Approval
12/23/2014 RETROVIR
NDA #019910		 SUPPL-41 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
12/23/2014 RETROVIR
NDA #019951		 SUPPL-32 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
12/23/2014 RETROVIR
NDA #020518		 SUPPL-24 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
12/23/2014 CAFCIT
NDA #020793		 SUPPL-16 CAFFEINE CITRATE HIKMA Manufacturing (CMC) Approval
12/23/2014 DEPOCYT
NDA #021041		 SUPPL-31 CYTARABINE PACIRA PHARMS INC Labeling Approval
12/23/2014 TACLONEX
NDA #021852		 SUPPL-15 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Efficacy Approval
12/23/2014 DYLOJECT
NDA #022396		 ORIG-1 DICLOFENAC SODIUM JAVELIN PHARMS INC Type 3 - New Dosage Form Approval
12/23/2014 PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
ANDA #040674		 ORIG-1 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE HIKMA Approval
12/23/2014 PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
ANDA #040675		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE HIKMA Approval
12/23/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #040804		 SUPPL-3 HYDROXYZINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
12/23/2014 DYNACIN
ANDA #063067		 SUPPL-38 MINOCYCLINE HYDROCHLORIDE ALVOGEN Labeling Approval
12/23/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075514		 SUPPL-12 FLUOXETINE HYDROCHLORIDE PHARMOBEDIENT CNSLTG Labeling Approval
12/23/2014 ALENDRONATE SODIUM
ANDA #077982		 SUPPL-2 ALENDRONATE SODIUM APOTEX Labeling Approval
12/23/2014 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #081249		 SUPPL-4 ACETAMINOPHEN; CODEINE PHOSPHATE FOSUN PHARMA Labeling Approval
12/23/2014 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #081250		 SUPPL-5 ACETAMINOPHEN; CODEINE PHOSPHATE FOSUN PHARMA Labeling Approval
12/23/2014 NEULASTA
BLA #125031		 SUPPL-175 PEGFILGRASTIM AMGEN Approval
12/23/2014 PURIXAN
NDA #205919		 SUPPL-1 MERCAPTOPURINE NOVA LABS LTD Manufacturing (CMC) Approval
12/23/2014 SAXENDA
NDA #206321		 ORIG-1 LIRAGLUTIDE NOVO Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approval
12/23/2014 NAMZARIC
NDA #206439		 ORIG-1 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE ABBVIE Type 4 - New Combination Approval
12/24/2014 CAPOTEN
NDA #018343		 SUPPL-85 CAPTOPRIL AARXION ANDA HLDING Labeling Approval
12/24/2014 VASOTEC
NDA #018998		 SUPPL-79 ENALAPRIL MALEATE BAUSCH Labeling Approval
12/24/2014 VASERETIC
NDA #019221		 SUPPL-44 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE BAUSCH Labeling Approval
12/24/2014 ZESTRIL
NDA #019777		 SUPPL-64 LISINOPRIL TWI PHARMS Labeling Approval
12/24/2014 ZESTORETIC
NDA #019888		 SUPPL-56 HYDROCHLOROTHIAZIDE; LISINOPRIL ALMATICA Labeling Approval
12/24/2014 MAVIK
NDA #020528		 SUPPL-23 TRANDOLAPRIL ABBVIE Labeling Approval
12/24/2014 TARKA
NDA #020591		 SUPPL-25 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE ABBVIE Labeling Approval
12/24/2014 ZYBAN
NDA #020711		 SUPPL-42 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/24/2014 ACTIQ
NDA #020747		 SUPPL-41 FENTANYL CITRATE CEPHALON REMS Approval
12/24/2014 FENTORA
NDA #021947		 SUPPL-22 FENTANYL CITRATE CEPHALON REMS Approval
12/24/2014 ONSOLIS
NDA #022266		 SUPPL-14 FENTANYL CITRATE ADALVO REMS Approval
12/24/2014 ABSTRAL
NDA #022510		 SUPPL-14 FENTANYL CITRATE SENTYNL THERAPS INC REMS Approval
12/24/2014 LAZANDA
NDA #022569		 SUPPL-13 FENTANYL CITRATE BTCP PHARMA Labeling Approval
12/24/2014 LAZANDA
NDA #022569		 SUPPL-19 FENTANYL CITRATE BTCP PHARMA Labeling Approval
12/24/2014 LAZANDA
NDA #022569		 SUPPL-20 FENTANYL CITRATE BTCP PHARMA REMS Approval
12/24/2014 METRONIDAZOLE
ANDA #070027		 SUPPL-37 METRONIDAZOLE TEVA PHARMS USA Manufacturing (CMC) Approval
12/24/2014 METRONIDAZOLE
ANDA #070033		 SUPPL-37 METRONIDAZOLE PLIVA Manufacturing (CMC) Approval
12/24/2014 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #074650		 SUPPL-12 SULFAMETHOXAZOLE; TRIMETHOPRIM HIKMA Manufacturing (CMC) Approval
12/24/2014 FENTANYL CITRATE
ANDA #077312		 SUPPL-6 FENTANYL CITRATE PAR PHARM REMS Approval
12/24/2014 ZOLPIDEM TARTRATE
ANDA #077903		 SUPPL-17 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
12/24/2014 ZOLPIDEM TARTRATE
ANDA #077903		 SUPPL-19 ZOLPIDEM TARTRATE TORRENT PHARMS Labeling Approval
12/24/2014 FENTANYL CITRATE
ANDA #078907		 SUPPL-12 FENTANYL CITRATE SPECGX LLC REMS Approval
12/24/2014 HUMIRA
BLA #125057		 SUPPL-280 ADALIMUMAB ABBVIE INC Approval
12/24/2014 GAZYVA
BLA #125486		 SUPPL-9 OBINUTUZUMAB GENENTECH Approval
12/24/2014 SUBSYS
NDA #202788		 SUPPL-9 FENTANYL BTCP PHARMA Labeling Approval
12/24/2014 SUBSYS
NDA #202788		 SUPPL-11 FENTANYL BTCP PHARMA Manufacturing (CMC) Approval
12/24/2014 SUBSYS
NDA #202788		 SUPPL-12 FENTANYL BTCP PHARMA REMS Approval
12/29/2014 OMECLAMOX-PAK
NDA #050824		 SUPPL-4 AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE CUMBERLAND Labeling Approval
12/29/2014 FLUOROURACIL
ANDA #077524		 SUPPL-2 FLUOROURACIL DR REDDYS LABS SA Labeling Approval
12/29/2014 ZOLPIDEM TARTRATE
ANDA #077990		 SUPPL-5 ZOLPIDEM TARTRATE YUNG SHIN PHARM Labeling Approval
12/29/2014 GADAVIST
NDA #201277		 SUPPL-8 GADOBUTROL BAYER HLTHCARE Efficacy Approval
12/29/2014 INLYTA
NDA #202324		 SUPPL-3 AXITINIB PF PRISM CV Labeling Approval
12/29/2014 MORPHINE SULFATE
ANDA #202718		 ORIG-1 MORPHINE SULFATE TEVA PHARMS USA Approval
12/29/2014 KALYDECO
NDA #203188		 SUPPL-14 IVACAFTOR VERTEX PHARMS Efficacy Approval
12/29/2014 KALYDECO
NDA #203188		 SUPPL-15 IVACAFTOR VERTEX PHARMS Labeling Approval
12/30/2014 LAMICTAL
NDA #020241		 SUPPL-35 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 LAMICTAL
NDA #020241		 SUPPL-40 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 LAMICTAL CD
NDA #020764		 SUPPL-28 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 LAMICTAL CD
NDA #020764		 SUPPL-33 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 WELLBUTRIN XL
NDA #021515		 SUPPL-29 BUPROPION HYDROCHLORIDE BAUSCH Labeling Approval
12/30/2014 WELLBUTRIN XL
NDA #021515		 SUPPL-30 BUPROPION HYDROCHLORIDE BAUSCH Labeling Approval
12/30/2014 APLENZIN
NDA #022108		 SUPPL-9 BUPROPION HYDROBROMIDE BAUSCH Labeling Approval
12/30/2014 LAMICTAL XR
NDA #022115		 SUPPL-4 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 LAMICTAL XR
NDA #022115		 SUPPL-14 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 LAMICTAL ODT
NDA #022251		 SUPPL-2 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 LAMICTAL ODT
NDA #022251		 SUPPL-9 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/30/2014 NATROBA
NDA #022408		 SUPPL-5 SPINOSAD CIPHER Efficacy Approval
12/30/2014 CETIRIZINE HYDROCHLORIDE
ANDA #090191		 SUPPL-2 CETIRIZINE HYDROCHLORIDE BAJAJ Manufacturing (CMC) Approval
12/30/2014 MEFENAMIC ACID
ANDA #090359		 SUPPL-2 MEFENAMIC ACID MPP PHARMA Manufacturing (CMC) Approval
12/30/2014 ORENCIA
BLA #125118		 SUPPL-179 ABATACEPT BRISTOL MYERS SQUIBB Approval
12/30/2014 BUSPIRONE HYDROCHLORIDE
ANDA #202557		 ORIG-1 BUSPIRONE HYDROCHLORIDE ACCORD HLTHCARE Approval
12/31/2014 LOTREL
NDA #020364		 SUPPL-58 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ Labeling Approval
12/31/2014 NORTREL 7/7/7
ANDA #075478		 SUPPL-13 ETHINYL ESTRADIOL; NORETHINDRONE BARR Labeling Approval
12/31/2014 CILOSTAZOL
ANDA #077027		 SUPPL-10 CILOSTAZOL TEVA Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077343		 SUPPL-6 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077343		 SUPPL-7 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077343		 SUPPL-8 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077368		 SUPPL-5 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077368		 SUPPL-6 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077368		 SUPPL-7 ONDANSETRON HYDROCHLORIDE APOTEX INC Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077851		 SUPPL-2 ONDANSETRON HYDROCHLORIDE NATCO PHARMA LTD Labeling Approval
12/31/2014 ONDANSETRON HYDROCHLORIDE
ANDA #077851		 SUPPL-3 ONDANSETRON HYDROCHLORIDE NATCO PHARMA LTD Labeling Approval
12/31/2014 IBUPROFEN AND DIPHENHYDRAMINE CITRATE
ANDA #079113		 SUPPL-5 DIPHENHYDRAMINE CITRATE; IBUPROFEN PERRIGO R AND D Labeling Approval
12/31/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #088350		 SUPPL-45 HYDROXYZINE HYDROCHLORIDE WATSON LABS Labeling Approval
12/31/2014 RIZATRIPTAN BENZOATE
ANDA #203252		 ORIG-1 RIZATRIPTAN BENZOATE JUBILANT GENERICS Approval
12/31/2014 LAMIVUDINE
ANDA #204002		 ORIG-1 LAMIVUDINE AUROBINDO PHARMA USA Approval
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