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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 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 08, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/01/2014 LOESTRIN FE 1/20
NDA #017354		 SUPPL-46 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/01/2014 STERILE WATER FOR INJECTION
NDA #018801		 SUPPL-36 STERILE WATER FOR INJECTION HOSPIRA Manufacturing (CMC) Approval
08/01/2014 METRONIDAZOLE IN PLASTIC CONTAINER
NDA #018890		 SUPPL-49 METRONIDAZOLE HOSPIRA Manufacturing (CMC) Approval
08/01/2014 DIFFERIN
NDA #020748		 SUPPL-9 ADAPALENE GALDERMA LABS LP Manufacturing (CMC) Approval
08/01/2014 KEPPRA XR
NDA #022285		 SUPPL-18 LEVETIRACETAM UCB INC Efficacy Approval
08/01/2014 EPIDUO
NDA #022320		 SUPPL-8 ADAPALENE; BENZOYL PEROXIDE GALDERMA LABS LP Manufacturing (CMC) Approval
08/01/2014 TYVASO
NDA #022387		 SUPPL-11 TREPROSTINIL UNITED THERAP Labeling Approval
08/01/2014 NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
ANDA #062938		 SUPPL-14 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE PADAGIS US Manufacturing (CMC) Approval
08/01/2014 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #075618		 SUPPL-21 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE HIKMA INTL PHARMS Labeling Approval
08/01/2014 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #076475		 SUPPL-15 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/01/2014 GLIMEPIRIDE
ANDA #078181		 SUPPL-6 GLIMEPIRIDE ACCORD HLTHCARE Labeling Approval
08/01/2014 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #090460		 SUPPL-2 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
08/01/2014 DOXYCYCLINE
ANDA #090855		 ORIG-1 DOXYCYCLINE MYLAN Tentative Approval
08/01/2014 SILDENAFIL CITRATE
ANDA #091379		 SUPPL-1 SILDENAFIL CITRATE APOTEX CORP Labeling Approval
08/01/2014 LUMIZYME
BLA #125291		 SUPPL-136 ALGLUCOSIDASE ALFA GENZYME Approval
08/01/2014 HALAVEN
NDA #201532		 SUPPL-9 ERIBULIN MESYLATE EISAI INC Labeling Approval
08/01/2014 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #201952		 SUPPL-1 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE MICRO LABS LTD INDIA Labeling Approval
08/01/2014 INLYTA
NDA #202324		 SUPPL-2 AXITINIB PF PRISM CV Labeling Approval
08/01/2014 OXYCODONE HYDROCHLORIDE
ANDA #203823		 ORIG-1 OXYCODONE HYDROCHLORIDE LANNETT CO INC Approval
08/01/2014 JARDIANCE
NDA #204629		 ORIG-1 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Type 1 - New Molecular Entity Approval
08/03/2014 MIRALAX
NDA #022015		 SUPPL-20 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
08/04/2014 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #075929		 SUPPL-13 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE PHARMOBEDIENT Labeling Approval
08/04/2014 CYCLAFEM 1/35
ANDA #076337		 SUPPL-7 ETHINYL ESTRADIOL; NORETHINDRONE PH HEALTH Manufacturing (CMC) Approval
08/04/2014 MYZILRA
ANDA #077502		 SUPPL-4 ETHINYL ESTRADIOL; LEVONORGESTREL PH HEALTH Manufacturing (CMC) Approval
08/04/2014 KETOROLAC TROMETHAMINE
ANDA #201155		 ORIG-1 KETOROLAC TROMETHAMINE ONESOURCE SPECIALTY Approval
08/04/2014 SIRTURO
NDA #204384		 SUPPL-3 BEDAQUILINE FUMARATE JANSSEN THERAP Manufacturing (CMC) Approval
08/05/2014 LOESTRIN FE 1.5/30
NDA #017355		 SUPPL-48 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/05/2014 ZOSYN
NDA #050684		 SUPPL-82 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Manufacturing (CMC) Approval
08/05/2014 AZITHROMYCIN
ANDA #065302		 SUPPL-2 AZITHROMYCIN CHARTWELL RX Labeling Approval
08/05/2014 AZITHROMYCIN
ANDA #065404		 SUPPL-4 AZITHROMYCIN CHARTWELL RX Labeling Approval
08/05/2014 AZITHROMYCIN
ANDA #065405		 SUPPL-4 AZITHROMYCIN CHARTWELL RX Labeling Approval
08/05/2014 PENICILLIN V POTASSIUM
ANDA #065435		 SUPPL-5 PENICILLIN V POTASSIUM AUROBINDO PHARMA Labeling Approval
08/05/2014 VINCRISTINE SULFATE PFS
ANDA #071484		 SUPPL-42 VINCRISTINE SULFATE HOSPIRA Labeling Approval
08/05/2014 VALPROIC ACID
ANDA #073229		 SUPPL-11 VALPROIC ACID CATALENT Labeling Approval
08/05/2014 PANTOPRAZOLE SODIUM
ANDA #078281		 SUPPL-6 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
08/05/2014 BIMATOPROST
ANDA #203056		 ORIG-1 BIMATOPROST SANDOZ INC Tentative Approval
08/06/2014 PHENTERMINE HYDROCHLORIDE
ANDA #203068		 ORIG-1 PHENTERMINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/06/2014 POTASSIUM CITRATE
ANDA #203546		 ORIG-1 POTASSIUM CITRATE ZYDUS PHARMS Approval
08/06/2014 FLUDEOXYGLUCOSE F18
ANDA #203990		 ORIG-1 FLUDEOXYGLUCOSE F-18 UIHC PET IMAGING Approval
08/06/2014 ORBACTIV
NDA #206334		 ORIG-1 ORITAVANCIN DIPHOSPHATE MELINTA THERAP Type 1 - New Molecular Entity Approval
08/07/2014 NORPRAMIN
NDA #014399		 SUPPL-68 DESIPRAMINE HYDROCHLORIDE VALIDUS PHARMS Manufacturing (CMC) Approval
08/07/2014 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/07/2014 DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/07/2014 DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/07/2014 DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/07/2014 DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/07/2014 DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS MEDCL Manufacturing (CMC) Approval
08/07/2014 ANGIOMAX
NDA #020873		 SUPPL-31 BIVALIRUDIN SANDOZ Manufacturing (CMC) Approval
08/07/2014 OPTIMARK
NDA #020937		 SUPPL-23 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
08/07/2014 OPTIMARK
NDA #020975		 SUPPL-24 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
08/07/2014 OPTIMARK IN PLASTIC CONTAINER
NDA #020976		 SUPPL-25 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
08/07/2014 AXERT
NDA #021001		 SUPPL-14 ALMOTRIPTAN MALATE JANSSEN PHARMS Labeling Approval
08/07/2014 KEPPRA
NDA #021035		 SUPPL-94 LEVETIRACETAM UCB INC Labeling Approval
08/07/2014 KEPPRA
NDA #021505		 SUPPL-34 LEVETIRACETAM UCB INC Labeling Approval
08/07/2014 KEPPRA
NDA #021872		 SUPPL-18 LEVETIRACETAM UCB INC Labeling Approval
08/07/2014 KEPPRA XR
NDA #022285		 SUPPL-20 LEVETIRACETAM UCB INC Labeling Approval
08/07/2014 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091351		 ORIG-1 HYDROCHLOROTHIAZIDE; TELMISARTAN LUPIN Approval
08/07/2014 HUMIRA
BLA #125057		 SUPPL-381 ADALIMUMAB ABBVIE INC Approval
08/08/2014 XANAX
NDA #018276		 SUPPL-49 ALPRAZOLAM UPJOHN Manufacturing (CMC) Approval
08/08/2014 VIDEX
NDA #020156		 SUPPL-51 DIDANOSINE BRISTOL Labeling Approval
08/08/2014 VELCADE
NDA #021602		 SUPPL-38 BORTEZOMIB TAKEDA PHARMS USA Efficacy Approval
08/08/2014 SILENOR
NDA #022036		 SUPPL-3 DOXEPIN HYDROCHLORIDE CURRAX Manufacturing (CMC) Approval
08/08/2014 CAPECITABINE
ANDA #090943		 ORIG-1 CAPECITABINE RISING Approval
08/08/2014 FARXIGA
NDA #202293		 SUPPL-3 DAPAGLIFLOZIN ASTRAZENECA AB Labeling Approval
08/08/2014 JUXTAPID
NDA #203858		 SUPPL-9 LOMITAPIDE MESYLATE CHIESI Labeling Approval
08/08/2014 INVOKAMET
NDA #204353		 ORIG-1 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Type 4 - New Combination Approval
08/09/2014 TETRACYCLINE HYDROCHLORIDE
ANDA #060783		 SUPPL-26 TETRACYCLINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
08/09/2014 AZITHROMYCIN
ANDA #065360		 SUPPL-6 AZITHROMYCIN AUROBINDO PHARMA USA Labeling Approval
08/11/2014 QUINIDINE GLUCONATE
NDA #007529		 SUPPL-43 QUINIDINE GLUCONATE LILLY Manufacturing (CMC) Approval
08/11/2014 HUMATROPE
BLA #019640		 SUPPL-96 SOMATROPIN LILLY Approval
08/11/2014 SAIZEN
BLA #019764		 SUPPL-74 SOMATROPIN EMD SERONO Approval
08/11/2014 GONAL-F
BLA #020378		 SUPPL-65 FOLLITROPIN ALFA/BETA EMD SERONO Approval
08/11/2014 GEMZAR
NDA #020509		 SUPPL-76 GEMCITABINE HYDROCHLORIDE LILLY Manufacturing (CMC) Approval
08/11/2014 SEROSTIM
BLA #020604		 SUPPL-82 SOMATROPIN EMD SERONO Approval
08/11/2014 SEROSTIM LQ
BLA #020604		 SUPPL-82 SOMATROPIN EMD SERONO Approval
08/11/2014 GLUCAGON
NDA #020928		 SUPPL-49 GLUCAGON LILLY Manufacturing (CMC) Approval
08/11/2014 CONCERTA
NDA #021121		 SUPPL-33 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Manufacturing (CMC) Approval
08/11/2014 ZYPREXA
NDA #021253		 SUPPL-52 OLANZAPINE CHEPLAPHARM Manufacturing (CMC) Approval
08/11/2014 ALIMTA
NDA #021462		 SUPPL-47 PEMETREXED DISODIUM LILLY Manufacturing (CMC) Approval
08/11/2014 NAMENDA
NDA #021627		 SUPPL-12 MEMANTINE HYDROCHLORIDE ALLERGAN Labeling Approval
08/11/2014 GONAL-F
BLA #021765		 SUPPL-35 FOLLITROPIN ALFA/BETA EMD SERONO Approval
08/11/2014 GONAL-F RFF
BLA #021765		 SUPPL-35 FOLLITROPIN ALFA/BETA EMD SERONO Approval
08/11/2014 MINOCYCLINE HYDROCHLORIDE
ANDA #065470		 SUPPL-6 MINOCYCLINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/11/2014 MORPHINE SULFATE
ANDA #075295		 SUPPL-35 MORPHINE SULFATE STRIDES PHARMA INTL Labeling Approval
08/11/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076015		 SUPPL-10 FLUOXETINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
08/11/2014 NAPROXEN SODIUM
ANDA #079096		 SUPPL-9 NAPROXEN SODIUM AMNEAL PHARMS NY Labeling Approval
08/11/2014 INTRON A
BLA #103132		 SUPPL-5190 INTERFERON ALFA-2B SCHERING Approval
08/11/2014 PEGINTRON
BLA #103949		 SUPPL-5288 PEGINTERFERON ALFA-2B SCHERING Approval
08/11/2014 SYLATRON
BLA #103949		 SUPPL-5288 PEGINTERFERON ALFA-2B SCHERING Approval
08/11/2014 ZORVOLEX
NDA #204592		 SUPPL-3 DICLOFENAC ZYLA Manufacturing (CMC) Approval
08/12/2014 ROBAXIN
NDA #011790		 SUPPL-51 METHOCARBAMOL HIKMA PHARMS Manufacturing (CMC) Approval
08/12/2014 NUTRILIPID 10%
NDA #019531		 SUPPL-2 SOYBEAN OIL B BRAUN Manufacturing (CMC) Approval
08/12/2014 NUTRILIPID 20%
NDA #019531		 SUPPL-2 SOYBEAN OIL B BRAUN Manufacturing (CMC) Approval
08/12/2014 ESTRING
NDA #020472		 SUPPL-11 ESTRADIOL PFIZER Labeling Approval
08/12/2014 MELOXICAM
NDA #021530		 SUPPL-12 MELOXICAM AVONDALE PHARMS Manufacturing (CMC) Approval
08/12/2014 EMEND
NDA #021549		 SUPPL-24 APREPITANT MSD Labeling Approval
08/12/2014 FEMTRACE
NDA #021633		 SUPPL-5 ESTRADIOL ACETATE APIL Labeling Approval
08/12/2014 BYETTA
NDA #021773		 SUPPL-39 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
08/12/2014 EMEND
NDA #022023		 SUPPL-11 FOSAPREPITANT DIMEGLUMINE MERCK AND CO INC Labeling Approval
08/12/2014 LASTACAFT
NDA #022134		 SUPPL-2 ALCAFTADINE ABBVIE Manufacturing (CMC) Approval
08/12/2014 VIMPAT
NDA #022253		 SUPPL-28 LACOSAMIDE UCB INC Labeling Approval
08/12/2014 VIMPAT
NDA #022254		 SUPPL-21 LACOSAMIDE UCB INC Labeling Approval
08/12/2014 VIMPAT
NDA #022255		 SUPPL-14 LACOSAMIDE UCB INC Labeling Approval
08/12/2014 COARTEM
NDA #022268		 SUPPL-10 ARTEMETHER; LUMEFANTRINE NOVARTIS Manufacturing (CMC) Approval
08/12/2014 SUBOXONE
NDA #022410		 SUPPL-19 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
08/12/2014 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075817		 SUPPL-15 CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
08/12/2014 LORATADINE
ANDA #077421		 SUPPL-4 LORATADINE LANNETT CO INC Labeling Approval
08/12/2014 GALANTAMINE HYDROBROMIDE
ANDA #077605		 SUPPL-7 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
08/12/2014 GALANTAMINE HYDROBROMIDE
ANDA #078189		 SUPPL-7 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
08/12/2014 ROXICET
ANDA #087003		 SUPPL-36 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/12/2014 RITUXAN
BLA #103705		 SUPPL-5432 RITUXIMAB GENENTECH Approval
08/12/2014 RAYOS
NDA #202020		 SUPPL-7 PREDNISONE HORIZON Manufacturing (CMC) Approval
08/12/2014 ELIQUIS
NDA #202155		 SUPPL-9 APIXABAN BRISTOL MYERS SQUIBB REMS Approval
08/12/2014 RIBAVIRIN
ANDA #202546		 ORIG-1 RIBAVIRIN BEXIMCO PHARMS USA Approval
08/12/2014 BEXAROTENE
ANDA #203174		 ORIG-1 BEXAROTENE BIONPHARMA Approval
08/12/2014 TRANEXAMIC ACID
ANDA #203521		 ORIG-1 TRANEXAMIC ACID AVET LIFESCIENCES Approval
08/13/2014 DIPROLENE
NDA #018741		 SUPPL-36 BETAMETHASONE DIPROPIONATE ORGANON Labeling Approval
08/13/2014 DIPROLENE AF
NDA #019555		 SUPPL-33 BETAMETHASONE DIPROPIONATE ORGANON Labeling Approval
08/13/2014 DIPROLENE
NDA #019716		 SUPPL-30 BETAMETHASONE DIPROPIONATE ORGANON Labeling Approval
08/13/2014 PROMETRIUM
NDA #019781		 SUPPL-19 PROGESTERONE ACERTIS PHARMS Manufacturing (CMC) Approval
08/13/2014 NILANDRON
NDA #020169		 SUPPL-6 NILUTAMIDE ADVANZ PHARMA Manufacturing (CMC) Approval
08/13/2014 NAVELBINE
NDA #020388		 SUPPL-30 VINORELBINE TARTRATE PIERRE FABRE Manufacturing (CMC) Approval
08/13/2014 ZYBAN
NDA #020711		 SUPPL-43 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
08/13/2014 DEPOCYT
NDA #021041		 SUPPL-29 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
08/13/2014 FORTEO
NDA #021318		 SUPPL-40 TERIPARATIDE LILLY Manufacturing (CMC) Approval
08/13/2014 TOVIAZ
NDA #022030		 SUPPL-10 FESOTERODINE FUMARATE PFIZER Manufacturing (CMC) Approval
08/13/2014 EXPAREL
NDA #022496		 SUPPL-8 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
08/13/2014 CEFADROXIL
ANDA #062698		 SUPPL-7 CEFADROXIL/CEFADROXIL HEMIHYDRATE ANI PHARMS Labeling Approval
08/13/2014 MORPHINE SULFATE
ANDA #076412		 SUPPL-11 MORPHINE SULFATE SPECGX LLC Labeling Approval
08/13/2014 MORPHINE SULFATE
ANDA #076438		 SUPPL-9 MORPHINE SULFATE SPECGX LLC Labeling Approval
08/13/2014 MEKINIST
NDA #204114		 SUPPL-2 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Manufacturing (CMC) Approval
08/13/2014 BELSOMRA
NDA #204569		 ORIG-1 SUVOREXANT MERCK SHARP DOHME Type 1 - New Molecular Entity Approval
08/13/2014 ETOMIDATE
ANDA #204618		 ORIG-1 ETOMIDATE AVET LIFESCIENCES Approval
08/13/2014 NEURACEQ
NDA #204677		 SUPPL-4 FLORBETABEN F-18 LANTHEUS Manufacturing (CMC) Approval
08/14/2014 METOPIRONE
NDA #012911		 SUPPL-34 METYRAPONE ESTEVE Manufacturing (CMC) Approval
08/14/2014 LOTENSIN HCT
NDA #020033		 SUPPL-49 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Manufacturing (CMC) Approval
08/14/2014 MIGRANAL
NDA #020148		 SUPPL-24 DIHYDROERGOTAMINE MESYLATE BAUSCH Manufacturing (CMC) Approval
08/14/2014 SUSTIVA
NDA #020972		 SUPPL-47 EFAVIRENZ BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
08/14/2014 NICORETTE
NDA #021330		 SUPPL-17 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
08/14/2014 SUSTIVA
NDA #021360		 SUPPL-36 EFAVIRENZ BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
08/14/2014 COMBIVENT RESPIMAT
NDA #021747		 SUPPL-3 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
08/14/2014 COLCRYS
NDA #022352		 SUPPL-17 COLCHICINE TAKEDA PHARMS USA Labeling Approval
08/14/2014 PRADAXA
NDA #022512		 SUPPL-23 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
08/14/2014 DONEPEZIL HYDROCHLORIDE
ANDA #076786		 SUPPL-6 DONEPEZIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
08/14/2014 PEGINTRON
BLA #103949		 SUPPL-5285 PEGINTERFERON ALFA-2B SCHERING Approval
08/14/2014 SYLATRON
BLA #103949		 SUPPL-5285 PEGINTERFERON ALFA-2B SCHERING Approval
08/14/2014 AVASTIN
BLA #125085		 SUPPL-301 BEVACIZUMAB GENENTECH Approval
08/14/2014 VASCEPA
NDA #202057		 SUPPL-10 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
08/14/2014 DECITABINE
NDA #205582		 SUPPL-1 DECITABINE SUN PHARM Manufacturing (CMC) Approval
08/14/2014 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #205861		 ORIG-1 EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Type 5 - New Formulation or New Manufacturer Tentative Approval
08/15/2014 DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #017608		 SUPPL-139 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019416		 SUPPL-32 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685		 SUPPL-31 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE OTSUKA ICU MEDCL Manufacturing (CMC) Approval
08/15/2014 ABSORICA
NDA #021951		 SUPPL-3 ISOTRETINOIN SUN PHARM INDS INC Manufacturing (CMC) Approval
08/15/2014 ERYTHROMYCIN STEARATE
ANDA #061505		 SUPPL-34 ERYTHROMYCIN STEARATE PHARMOBEDIENT Labeling Approval
08/15/2014 BACITRACIN ZINC AND POLYMYXIN B SULFATE
ANDA #065022		 SUPPL-4 BACITRACIN ZINC; POLYMYXIN B SULFATE PADAGIS US Manufacturing (CMC) Approval
08/15/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #065458		 ORIG-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ONESOURCE SPECIALTY Approval
08/15/2014 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385		 SUPPL-11 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
08/15/2014 TYLENOL W/ CODEINE NO. 1
ANDA #085055		 SUPPL-54 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
08/15/2014 TYLENOL W/ CODEINE NO. 2
ANDA #085055		 SUPPL-54 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
08/15/2014 TYLENOL W/ CODEINE NO. 3
ANDA #085055		 SUPPL-54 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
08/15/2014 TYLENOL W/ CODEINE NO. 4
ANDA #085055		 SUPPL-54 ACETAMINOPHEN; CODEINE PHOSPHATE JANSSEN PHARMS Labeling Approval
08/15/2014 SILDENAFIL CITRATE
ANDA #091479		 SUPPL-2 SILDENAFIL CITRATE TORRENT PHARMS LTD Labeling Approval
08/15/2014 PLEGRIDY
BLA #125499		 ORIG-1 PEGINTERFERON BETA-1A BIOGEN IDEC INC Approval
08/15/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #202191		 ORIG-1 METOCLOPRAMIDE HYDROCHLORIDE NOVEL LABS INC Approval
08/15/2014 OLANZAPINE
ANDA #202862		 ORIG-1 OLANZAPINE MACLEODS PHARMS LTD Approval
08/15/2014 ABILIFY MAINTENA KIT
NDA #202971		 SUPPL-1 ARIPIPRAZOLE OTSUKA PHARM CO LTD Manufacturing (CMC) Approval
08/15/2014 ICLUSIG
NDA #203469		 SUPPL-11 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/16/2014 ACTOPLUS MET
NDA #021842		 SUPPL-19 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
08/18/2014 NEURONTIN
NDA #020235		 SUPPL-57 GABAPENTIN VIATRIS Labeling Approval
08/18/2014 NEURONTIN
NDA #020882		 SUPPL-41 GABAPENTIN VIATRIS Labeling Approval
08/18/2014 NEURONTIN
NDA #021129		 SUPPL-39 GABAPENTIN VIATRIS Labeling Approval
08/18/2014 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
ANDA #060764		 SUPPL-16 BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE PADAGIS US Manufacturing (CMC) Approval
08/18/2014 CEFAZOLIN SODIUM
ANDA #065306		 SUPPL-3 CEFAZOLIN SODIUM ACS DOBFAR Manufacturing (CMC) Approval
08/18/2014 HYDROMORPHONE HYDROCHLORIDE
NDA #200403		 SUPPL-3 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
08/18/2014 DOCETAXEL
NDA #201525		 SUPPL-7 DOCETAXEL SANDOZ Manufacturing (CMC) Approval
08/18/2014 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202881		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE MYLAN INSTITUTIONAL Approval
08/18/2014 TECFIDERA
NDA #204063		 SUPPL-5 DIMETHYL FUMARATE BIOGEN Manufacturing (CMC) Approval
08/18/2014 RIFAMPIN
ANDA #204101		 ORIG-1 RIFAMPIN AVET LIFESCIENCES Approval
08/19/2014 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-36 METHADONE HYDROCHLORIDE HIKMA PHARMS REMS Approval
08/19/2014 MS CONTIN
NDA #019516		 SUPPL-44 MORPHINE SULFATE KNOA PHARMA REMS Approval
08/19/2014 DURAGESIC-100
NDA #019813		 SUPPL-65 FENTANYL JANSSEN PHARMS REMS Approval
08/19/2014 DURAGESIC-12
NDA #019813		 SUPPL-65 FENTANYL JANSSEN PHARMS REMS Approval
08/19/2014 DURAGESIC-25
NDA #019813		 SUPPL-65 FENTANYL JANSSEN PHARMS REMS Approval
08/19/2014 DURAGESIC-37
NDA #019813		 SUPPL-65 FENTANYL JANSSEN PHARMS REMS Approval
08/19/2014 DURAGESIC-50
NDA #019813		 SUPPL-65 FENTANYL JANSSEN PHARMS REMS Approval
08/19/2014 DURAGESIC-75
NDA #019813		 SUPPL-65 FENTANYL JANSSEN PHARMS REMS Approval
08/19/2014 KADIAN
NDA #020616		 SUPPL-53 MORPHINE SULFATE ALLERGAN REMS Approval
08/19/2014 EXALGO
NDA #021217		 SUPPL-14 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
08/19/2014 AVINZA
NDA #021260		 SUPPL-23 MORPHINE SULFATE KING PHARMS LLC Supplement Approval
08/19/2014 BUTRANS
NDA #021306		 SUPPL-20 BUPRENORPHINE KNOA PHARMA REMS Approval
08/19/2014 OPANA ER
NDA #021610		 SUPPL-19 OXYMORPHONE HYDROCHLORIDE ENDO OPERATIONS REMS Approval
08/19/2014 OXYCONTIN
NDA #022272		 SUPPL-24 OXYCODONE HYDROCHLORIDE KNOA PHARMA REMS Approval
08/19/2014 EMBEDA
NDA #022321		 SUPPL-18 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS REMS Approval
08/19/2014 METHADOSE
ANDA #040050		 SUPPL-18 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE
ANDA #040241		 SUPPL-11 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-14 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #074769		 SUPPL-20 MORPHINE SULFATE RHODES PHARMS REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #074862		 SUPPL-20 MORPHINE SULFATE RHODES PHARMS REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #075295		 SUPPL-38 MORPHINE SULFATE STRIDES PHARMA INTL REMS Approval
08/19/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-37 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Manufacturing (CMC) Approval
08/19/2014 FENTANYL-100
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-12
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-25
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-37
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-50
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-62
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-75
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 FENTANYL-87
ANDA #076258		 SUPPL-30 FENTANYL MYLAN TECHNOLOGIES REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #076412		 SUPPL-18 MORPHINE SULFATE SPECGX LLC REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #076438		 SUPPL-15 MORPHINE SULFATE SPECGX LLC REMS Approval
08/19/2014 FENTANYL-100
ANDA #076709		 SUPPL-24 FENTANYL ACTAVIS LABS UT INC REMS Approval
08/19/2014 FENTANYL-25
ANDA #076709		 SUPPL-24 FENTANYL ACTAVIS LABS UT INC REMS Approval
08/19/2014 FENTANYL-50
ANDA #076709		 SUPPL-24 FENTANYL ACTAVIS LABS UT INC REMS Approval
08/19/2014 FENTANYL-75
ANDA #076709		 SUPPL-24 FENTANYL ACTAVIS LABS UT INC REMS Approval
08/19/2014 LORATADINE
ANDA #076805		 SUPPL-19 LORATADINE TARO Labeling Approval
08/19/2014 LORATADINE
ANDA #076805		 SUPPL-20 LORATADINE TARO Labeling Approval
08/19/2014 FENTANYL-100
ANDA #077062		 SUPPL-24 FENTANYL MAYNE PHARMA REMS Approval
08/19/2014 FENTANYL-25
ANDA #077062		 SUPPL-24 FENTANYL MAYNE PHARMA REMS Approval
08/19/2014 FENTANYL-50
ANDA #077062		 SUPPL-24 FENTANYL MAYNE PHARMA REMS Approval
08/19/2014 FENTANYL-75
ANDA #077062		 SUPPL-24 FENTANYL MAYNE PHARMA REMS Approval
08/19/2014 FENTANYL-100
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-12
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-25
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-37
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-50
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-62
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-75
ANDA #077154		 SUPPL-10 FENTANYL SPECGX LLC REMS Approval
08/19/2014 FENTANYL-100
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-12
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-25
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-37
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-50
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-62
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-75
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-87
ANDA #077449		 SUPPL-11 FENTANYL DIFGEN PHARMS REMS Approval
08/19/2014 FENTANYL-100
ANDA #077775		 SUPPL-18 FENTANYL NOVEN REMS Approval
08/19/2014 FENTANYL-25
ANDA #077775		 SUPPL-18 FENTANYL NOVEN REMS Approval
08/19/2014 FENTANYL-50
ANDA #077775		 SUPPL-18 FENTANYL NOVEN REMS Approval
08/19/2014 FENTANYL-75
ANDA #077775		 SUPPL-18 FENTANYL NOVEN REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #078761		 SUPPL-5 MORPHINE SULFATE SUN PHARM INDS LTD REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #079040		 SUPPL-7 MORPHINE SULFATE ACTAVIS ELIZABETH REMS Approval
08/19/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-18 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
08/19/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #079087		 SUPPL-17 OXYMORPHONE HYDROCHLORIDE IMPAX LABS REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-35 METHADONE HYDROCHLORIDE HIKMA PHARMS REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-26 METHADONE HYDROCHLORIDE HIKMA PHARMS REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-31 METHADONE HYDROCHLORIDE HIKMA PHARMS REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE
ANDA #090635		 SUPPL-9 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC REMS Approval
08/19/2014 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-5 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
08/19/2014 MYCOPHENOLATE SODIUM
ANDA #091558		 ORIG-2 MYCOPHENOLATE SODIUM APOTEX INC Approval
08/19/2014 NUCYNTA ER
NDA #200533		 SUPPL-11 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #200812		 SUPPL-5 MORPHINE SULFATE STRIDES PHARMA INTL REMS Approval
08/19/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #200822		 SUPPL-3 OXYMORPHONE HYDROCHLORIDE HIKMA PHARMS REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #200824		 SUPPL-8 MORPHINE SULFATE RISING REMS Approval
08/19/2014 OPANA ER
NDA #201655		 SUPPL-15 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS REMS Approval
08/19/2014 MORPHINE SULFATE
ANDA #202104		 SUPPL-4 MORPHINE SULFATE UPSHER SMITH LABS REMS Approval
08/19/2014 HYDROMORPHONE HYDROCHLORIDE
ANDA #202144		 SUPPL-5 HYDROMORPHONE HYDROCHLORIDE ACTAVIS LABS FL INC REMS Approval
08/19/2014 ZOHYDRO ER
NDA #202880		 SUPPL-2 HYDROCODONE BITARTRATE RECRO GAINESVILLE Labeling Approval
08/19/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #202946		 SUPPL-1 OXYMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
08/19/2014 ACYCLOVIR
ANDA #204314		 ORIG-1 ACYCLOVIR ZYDUS PHARMS Approval
08/19/2014 AMMONIA N 13
ANDA #204514		 ORIG-1 AMMONIA N-13 JOHNS HOPKINS UNIV Approval
08/19/2014 CERDELGA
NDA #205494		 ORIG-1 ELIGLUSTAT TARTRATE GENZYME CORP Type 1 - New Molecular Entity Approval
08/19/2014 TARGINIQ
NDA #205777		 SUPPL-1 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP REMS Approval
08/20/2014 DEPAKENE
NDA #018081		 SUPPL-61 VALPROIC ACID ABBVIE Labeling Approval
08/20/2014 DEPAKENE
NDA #018082		 SUPPL-44 VALPROIC ACID ABBVIE Labeling Approval
08/20/2014 DEPAKOTE
NDA #018723		 SUPPL-53 DIVALPROEX SODIUM ABBVIE Labeling Approval
08/20/2014 DEPAKOTE
NDA #019680		 SUPPL-40 DIVALPROEX SODIUM ABBVIE Labeling Approval
08/20/2014 ADENOSCAN
NDA #020059		 SUPPL-17 ADENOSINE ASTELLAS Labeling Approval
08/20/2014 ADENOSCAN
NDA #020059		 SUPPL-18 ADENOSINE ASTELLAS Labeling Approval
08/20/2014 DEPACON
NDA #020593		 SUPPL-31 VALPROATE SODIUM ABBVIE Labeling Approval
08/20/2014 DEPAKOTE ER
NDA #021168		 SUPPL-29 DIVALPROEX SODIUM ABBVIE Labeling Approval
08/20/2014 RADIOGARDASE (PRUSSIAN BLUE)
NDA #021626		 SUPPL-10 FERRIC HEXACYANOFERRATE(II) HEYL CHEMISCH Labeling Approval
08/20/2014 PRISTIQ
NDA #021992		 SUPPL-39 DESVENLAFAXINE SUCCINATE PF PRISM CV Type 1 - New Molecular Entity Approval
08/20/2014 INTELENCE
NDA #022187		 SUPPL-16 ETRAVIRINE JANSSEN R AND D Labeling Approval
08/20/2014 PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
ANDA #202217		 ORIG-1 BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE NOVEL LABS INC Approval
08/20/2014 MYTESI
NDA #202292		 SUPPL-2 CROFELEMER NAPO PHARMS INC Manufacturing (CMC) Approval
08/20/2014 LEVONORGESTREL
ANDA #202334		 ORIG-1 LEVONORGESTREL PERRIGO R AND D Approval
08/20/2014 HYDROXYZINE HYDROCHLORIDE
ANDA #204279		 ORIG-1 HYDROXYZINE HYDROCHLORIDE HERITAGE Approval
08/20/2014 CLINOLIPID 20%
NDA #204508		 SUPPL-2 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
08/20/2014 ARNUITY ELLIPTA
NDA #205625		 ORIG-1 FLUTICASONE FUROATE GLAXOSMITHKLINE Type 5 - New Formulation or New Manufacturer Approval
08/21/2014 PRALIDOXIME CHLORIDE (AUTOINJECTOR)
NDA #018986		 SUPPL-44 PRALIDOXIME CHLORIDE MERIDIAN MEDCL TECHN Manufacturing (CMC) Approval
08/21/2014 RETIN-A MICRO
NDA #020475		 SUPPL-24 TRETINOIN BAUSCH Manufacturing (CMC) Approval
08/21/2014 RETIN-A-MICRO
NDA #020475		 SUPPL-24 TRETINOIN BAUSCH Manufacturing (CMC) Approval
08/21/2014 SANDOSTATIN LAR
NDA #021008		 SUPPL-32 OCTREOTIDE ACETATE NOVARTIS Manufacturing (CMC) Approval
08/21/2014 ELIDEL
NDA #021302		 SUPPL-21 PIMECROLIMUS BAUSCH Manufacturing (CMC) Approval
08/21/2014 DUODOTE
NDA #021983		 SUPPL-14 ATROPINE; PRALIDOXIME CHLORIDE MMT Manufacturing (CMC) Approval
08/21/2014 REVATIO
NDA #022473		 SUPPL-8 SILDENAFIL CITRATE VIATRIS Manufacturing (CMC) Approval
08/21/2014 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078794		 ORIG-1 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE APOTEX Approval
08/21/2014 RIFAMPIN
ANDA #091181		 ORIG-1 RIFAMPIN FRESENIUS KABI USA Approval
08/21/2014 ZOLEDRONIC ACID
ANDA #200918		 ORIG-1 ZOLEDRONIC ACID EPIC PHARMA LLC Approval
08/21/2014 ELIQUIS
NDA #202155		 SUPPL-6 APIXABAN BRISTOL MYERS SQUIBB Efficacy Approval
08/21/2014 PREPOPIK
NDA #202535		 SUPPL-2 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FERRING PHARMS INC Manufacturing (CMC) Approval
08/21/2014 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202915		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE APOTEX Approval
08/21/2014 KAZANO
NDA #203414		 SUPPL-4 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/21/2014 POTASSIUM CHLORIDE
ANDA #204662		 ORIG-1 POTASSIUM CHLORIDE PHARMOBEDIENT Approval
08/22/2014 DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016683		 SUPPL-102 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/22/2014 PRINIVIL
NDA #019558		 SUPPL-58 LISINOPRIL MERCK Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-27 DEXTROSE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-27 DEXTROSE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-27 DEXTROSE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 7.7% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-27 DEXTROSE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-27 DEXTROSE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019630		 SUPPL-32 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019631		 SUPPL-31 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
08/22/2014 DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-29 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699		 SUPPL-21 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699		 SUPPL-21 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699		 SUPPL-21 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699		 SUPPL-21 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699		 SUPPL-21 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699		 SUPPL-21 DEXTROSE; POTASSIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019708		 SUPPL-22 POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019708		 SUPPL-22 POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019708		 SUPPL-22 POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019708		 SUPPL-22 POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019708		 SUPPL-22 POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019708		 SUPPL-22 POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019802		 SUPPL-16 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019802		 SUPPL-16 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019802		 SUPPL-16 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019826		 SUPPL-22 THEOPHYLLINE B BRAUN Manufacturing (CMC) Approval
08/22/2014 THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019826		 SUPPL-22 THEOPHYLLINE B BRAUN Manufacturing (CMC) Approval
08/22/2014 THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019826		 SUPPL-22 THEOPHYLLINE B BRAUN Manufacturing (CMC) Approval
08/22/2014 THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019826		 SUPPL-22 THEOPHYLLINE B BRAUN Manufacturing (CMC) Approval
08/22/2014 THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019826		 SUPPL-22 THEOPHYLLINE B BRAUN Manufacturing (CMC) Approval
08/22/2014 THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019826		 SUPPL-22 THEOPHYLLINE B BRAUN Manufacturing (CMC) Approval
08/22/2014 LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-15 LIDOCAINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-15 LIDOCAINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830		 SUPPL-15 LIDOCAINE HYDROCHLORIDE B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-20 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-20 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-20 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-20 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019953		 SUPPL-20 HEPARIN SODIUM B BRAUN Manufacturing (CMC) Approval
08/22/2014 AMPYRA
NDA #022250		 SUPPL-10 DALFAMPRIDINE MERZ Manufacturing (CMC) Approval
08/22/2014 GILENYA
NDA #022527		 SUPPL-14 FINGOLIMOD HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/22/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #065242		 SUPPL-2 CLINDAMYCIN HYDROCHLORIDE LANNETT Labeling Approval
08/22/2014 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078992		 SUPPL-1 DEXMETHYLPHENIDATE HYDROCHLORIDE PLATINUM Labeling Approval
08/22/2014 RIVASTIGMINE TARTRATE
ANDA #203148		 ORIG-1 RIVASTIGMINE TARTRATE MACLEODS PHARMS LTD Approval
08/22/2014 MINOCYCLINE HYDROCHLORIDE
ANDA #203443		 ORIG-1 MINOCYCLINE HYDROCHLORIDE RISING Approval
08/22/2014 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203460		 ORIG-1 MIDAZOLAM HYDROCHLORIDE FRESENIUS KABI USA Approval
08/22/2014 UCERIS
NDA #203634		 SUPPL-1 BUDESONIDE SALIX Manufacturing (CMC) Approval
08/22/2014 ZORVOLEX
NDA #204592		 SUPPL-2 DICLOFENAC ZYLA Efficacy Approval
08/22/2014 ZORVOLEX
NDA #204592		 SUPPL-4 DICLOFENAC ZYLA Labeling Approval
08/22/2014 TRIUMEQ
NDA #205551		 ORIG-1 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Type 4 - New Combination Approval
08/25/2014 DIABETA
NDA #017532		 SUPPL-36 GLYBURIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
08/25/2014 FASLODEX
NDA #021344		 SUPPL-24 FULVESTRANT ASTRAZENECA Manufacturing (CMC) Approval
08/25/2014 TRICOR
NDA #021656		 SUPPL-24 FENOFIBRATE ABBVIE Manufacturing (CMC) Approval
08/25/2014 VISIONBLUE
NDA #021670		 SUPPL-6 TRYPAN BLUE DORC Manufacturing (CMC) Approval
08/25/2014 INVEGA SUSTENNA
NDA #022264		 SUPPL-12 PALIPERIDONE PALMITATE JANSSEN PHARMS Manufacturing (CMC) Approval
08/25/2014 MEMBRANEBLUE
NDA #022278		 SUPPL-2 TRYPAN BLUE DORC Manufacturing (CMC) Approval
08/25/2014 CLINDAMYCIN HYDROCHLORIDE
ANDA #065242		 SUPPL-5 CLINDAMYCIN HYDROCHLORIDE LANNETT Labeling Approval
08/25/2014 AZITHROMYCIN
ANDA #065365		 SUPPL-8 AZITHROMYCIN PHARMOBEDIENT Labeling Approval
08/25/2014 AZITHROMYCIN
ANDA #065366		 SUPPL-7 AZITHROMYCIN EXTROVIS Labeling Approval
08/25/2014 AZITHROMYCIN
ANDA #065501		 SUPPL-2 AZITHROMYCIN GLAND PHARMA LTD Labeling Approval
08/25/2014 GRANISETRON HYDROCHLORIDE
ANDA #078843		 SUPPL-2 GRANISETRON HYDROCHLORIDE APOTEX INC Labeling Approval
08/25/2014 OXACILLIN SODIUM
ANDA #091486		 ORIG-1 OXACILLIN SODIUM ONESOURCE SPECIALTY Approval
08/25/2014 KABIVEN IN PLASTIC CONTAINER
NDA #200656		 ORIG-1 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Type 2 - New Active Ingredient Approval
08/25/2014 PERIKABIVEN IN PLASTIC CONTAINER
NDA #200656		 ORIG-1 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Type 2 - New Active Ingredient Approval
08/25/2014 BUSPIRONE HYDROCHLORIDE
ANDA #202330		 ORIG-1 BUSPIRONE HYDROCHLORIDE STRIDES PHARMA Approval
08/25/2014 TAFINLAR
NDA #202806		 SUPPL-3 DABRAFENIB MESYLATE NOVARTIS Manufacturing (CMC) Approval
08/26/2014 DOSTINEX
NDA #020664		 SUPPL-13 CABERGOLINE PFIZER Labeling Approval
08/26/2014 PROMACTA
NDA #022291		 SUPPL-12 ELTROMBOPAG OLAMINE NOVARTIS Efficacy Approval
08/26/2014 PRIMAXIN
NDA #050587		 SUPPL-75 CILASTATIN SODIUM; IMIPENEM MERCK Manufacturing (CMC) Approval
08/26/2014 COTRIM D.S.
ANDA #070048		 SUPPL-40 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Labeling Approval
08/26/2014 ENTECAVIR
ANDA #202122		 ORIG-1 ENTECAVIR TEVA PHARMS USA Approval
08/26/2014 TELMISARTAN AND AMLODIPINE
ANDA #202516		 ORIG-1 AMLODIPINE BESYLATE; TELMISARTAN MYLAN Approval
08/26/2014 XALKORI
NDA #202570		 SUPPL-12 CRIZOTINIB PF PRISM CV Manufacturing (CMC) Approval
08/26/2014 TELMISARTAN
ANDA #203325		 ORIG-1 TELMISARTAN ZYDUS PHARMS Approval
08/26/2014 FUROSEMIDE
ANDA #203428		 ORIG-1 FUROSEMIDE AVET LIFESCIENCES Approval
08/26/2014 NEVIRAPINE
ANDA #205921		 ORIG-1 NEVIRAPINE MYLAN LABS LTD Tentative Approval
08/27/2014 NEPHRAMINE 5.4%
NDA #017766		 SUPPL-41 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
08/27/2014 XOPENEX HFA
NDA #021730		 SUPPL-35 LEVALBUTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
08/27/2014 ELELYSO
BLA #022458		 SUPPL-3 TALIGLUCERASE ALFA PFIZER Approval
08/27/2014 ELELYSO
BLA #022458		 SUPPL-6 TALIGLUCERASE ALFA PFIZER Approval
08/27/2014 VIMOVO
NDA #022511		 SUPPL-14 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Manufacturing (CMC) Approval
08/27/2014 PHOSLYRA
NDA #022581		 SUPPL-5 CALCIUM ACETATE FRESENIUS MEDCL CARE Manufacturing (CMC) Approval
08/27/2014 CLONAZEPAM
ANDA #078654		 ORIG-1 CLONAZEPAM SUN PHARM INDS INC Approval
08/27/2014 OLOPATADINE HYDROCHLORIDE
ANDA #202526		 ORIG-1 OLOPATADINE HYDROCHLORIDE WATSON LABS INC Tentative Approval
08/27/2014 MEGESTROL ACETATE
ANDA #203139		 ORIG-1 MEGESTROL ACETATE TWI PHARMS Approval
08/27/2014 METOPROLOL TARTRATE
ANDA #204205		 ORIG-1 METOPROLOL TARTRATE GLAND Approval
08/28/2014 RIMSO-50
NDA #017788		 SUPPL-22 DIMETHYL SULFOXIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
08/28/2014 IFEX
NDA #019763		 SUPPL-19 IFOSFAMIDE BAXTER HLTHCARE Labeling Approval
08/28/2014 IFEX/MESNEX KIT
NDA #019763		 SUPPL-19 IFOSFAMIDE; MESNA BAXTER HLTHCARE Labeling Approval
08/28/2014 REQUIP
NDA #020658		 SUPPL-24 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP
NDA #020658		 SUPPL-26 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP
NDA #020658		 SUPPL-27 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP
NDA #020658		 SUPPL-30 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP
NDA #020658		 SUPPL-32 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP XL
NDA #022008		 SUPPL-3 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP XL
NDA #022008		 SUPPL-4 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP XL
NDA #022008		 SUPPL-7 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 REQUIP XL
NDA #022008		 SUPPL-8 ROPINIROLE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
08/28/2014 STAVZOR
NDA #022152		 SUPPL-7 VALPROIC ACID BIONPHARMA Labeling Approval
08/28/2014 ELLA
NDA #022474		 SUPPL-5 ULIPRISTAL ACETATE LAB HRA PHARMA Labeling Approval
08/28/2014 AVONEX
BLA #103628		 SUPPL-5129 INTERFERON BETA-1A BIOGEN Approval
08/28/2014 AVONEX
BLA #103628		 SUPPL-5177 INTERFERON BETA-1A BIOGEN Approval
08/28/2014 AVONEX
BLA #103628		 SUPPL-5194 INTERFERON BETA-1A BIOGEN Approval
08/28/2014 AVONEX
BLA #103628		 SUPPL-5224 INTERFERON BETA-1A BIOGEN Approval
08/28/2014 OXYCODONE AND ACETAMINOPHEN
ANDA #201278		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE RHODES PHARMS Approval
08/28/2014 CLARITHROMYCIN
ANDA #202710		 SUPPL-1 CLARITHROMYCIN NOVITIUM PHARMA Labeling Approval
08/28/2014 FROVATRIPTAN SUCCINATE
ANDA #202931		 ORIG-1 FROVATRIPTAN SUCCINATE PHARMOBEDIENT Approval
08/28/2014 DECITABINE
ANDA #202969		 ORIG-1 DECITABINE SANDOZ Approval
08/28/2014 STRIBILD
NDA #203100		 SUPPL-10 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
08/28/2014 METFORMIN HYDROCHLORIDE
ANDA #203686		 ORIG-1 METFORMIN HYDROCHLORIDE ZYDUS HLTHCARE Approval
08/28/2014 LAMIVUDINE AND ZIDOVUDINE
ANDA #204005		 ORIG-1 LAMIVUDINE; ZIDOVUDINE NATCO Approval
08/28/2014 ALEVE PM
NDA #205352		 SUPPL-1 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
08/29/2014 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016697		 SUPPL-97 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
NDA #019633		 SUPPL-31 STERILE WATER FOR INJECTION B BRAUN Manufacturing (CMC) Approval
08/29/2014 HEXALEN
NDA #019926		 SUPPL-25 ALTRETAMINE EISAI INC Manufacturing (CMC) Approval
08/29/2014 DOSTINEX
NDA #020664		 SUPPL-15 CABERGOLINE PFIZER Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-28 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-26 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
NDA #020849		 SUPPL-16 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
08/29/2014 CITANEST FORTE DENTAL
NDA #021383		 SUPPL-8 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE DENTSPLY PHARM Manufacturing (CMC) Approval
08/29/2014 OMNITROPE
BLA #021426		 SUPPL-28 SOMATROPIN SANDOZ Approval
08/29/2014 ZANAFLEX
NDA #021447		 SUPPL-12 TIZANIDINE HYDROCHLORIDE LEGACY Manufacturing (CMC) Approval
08/29/2014 RIOMET
NDA #021591		 SUPPL-8 METFORMIN HYDROCHLORIDE RANBAXY Manufacturing (CMC) Approval
08/29/2014 ZEMPLAR
NDA #021606		 SUPPL-12 PARICALCITOL ABBVIE Labeling Approval
08/29/2014 ZEMPLAR
NDA #021606		 SUPPL-14 PARICALCITOL ABBVIE Labeling Approval
08/29/2014 VIVITROL
NDA #021897		 SUPPL-27 NALTREXONE ALKERMES Manufacturing (CMC) Approval
08/29/2014 FENTORA
NDA #021947		 SUPPL-21 FENTANYL CITRATE CEPHALON Manufacturing (CMC) Approval
08/29/2014 ATRALIN
NDA #022070		 SUPPL-3 TRETINOIN DOW PHARM Labeling Approval
08/29/2014 TACLONEX
NDA #022185		 SUPPL-18 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Efficacy Approval
08/29/2014 TACLONEX
NDA #022185		 SUPPL-18 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Efficacy Approval
08/29/2014 VIMPAT
NDA #022253		 SUPPL-26 LACOSAMIDE UCB INC Efficacy Approval
08/29/2014 VIMPAT
NDA #022253		 SUPPL-27 LACOSAMIDE UCB INC Efficacy Approval
08/29/2014 VIMPAT
NDA #022254		 SUPPL-19 LACOSAMIDE UCB INC Efficacy Approval
08/29/2014 VIMPAT
NDA #022254		 SUPPL-20 LACOSAMIDE UCB INC Efficacy Approval
08/29/2014 VIMPAT
NDA #022255		 SUPPL-12 LACOSAMIDE UCB INC Efficacy Approval
08/29/2014 VIMPAT
NDA #022255		 SUPPL-13 LACOSAMIDE UCB INC Efficacy Approval
08/29/2014 CLEOCIN
NDA #050537		 SUPPL-36 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
08/29/2014 CLEOCIN T
NDA #050537		 SUPPL-36 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
08/29/2014 CEFTRIAXONE
ANDA #065342		 SUPPL-12 CEFTRIAXONE SODIUM HIKMA FARMACEUTICA Labeling Approval
08/29/2014 GRANISETRON HYDROCHLORIDE
ANDA #077186		 SUPPL-4 GRANISETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/29/2014 GRANISETRON HYDROCHLORIDE
ANDA #077187		 SUPPL-4 GRANISETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/29/2014 GRANISETRON HYDROCHLORIDE
ANDA #077913		 SUPPL-4 GRANISETRON HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/29/2014 NORETHINDRONE
ANDA #200961		 SUPPL-1 NORETHINDRONE NOVAST LABS Labeling Approval
08/29/2014 NORETHINDRONE
ANDA #202014		 SUPPL-1 NORETHINDRONE NOVAST LABS Labeling Approval
08/29/2014 TIVICAY
NDA #204790		 SUPPL-3 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Manufacturing (CMC) Approval
08/30/2014 PEGINTRON
BLA #103949		 SUPPL-5287 PEGINTERFERON ALFA-2B SCHERING Approval
08/30/2014 SYLATRON
BLA #103949		 SUPPL-5287 PEGINTERFERON ALFA-2B SCHERING Approval
08/30/2014 AVASTIN
BLA #125085		 SUPPL-297 BEVACIZUMAB GENENTECH Approval
08/30/2014 VECTIBIX
BLA #125147		 SUPPL-194 PANITUMUMAB AMGEN Approval
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