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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
June 2013

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

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

This report was produced on July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/03/2013 FIORINAL
NDA #017534		 SUPPL-71 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
06/03/2013 NORDETTE-28
NDA #018782		 SUPPL-36 ETHINYL ESTRADIOL; LEVONORGESTREL TEVA BRANDED PHARM Labeling Approval
06/03/2013 TRACLEER
NDA #021290		 SUPPL-24 BOSENTAN ACTELION Manufacturing (CMC) Approval
06/03/2013 HALFLYTELY
NDA #021551		 SUPPL-18 BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BRAINTREE Manufacturing (CMC) Approval
06/03/2013 EMBEDA
NDA #022321		 SUPPL-12 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Labeling Approval
06/03/2013 VPRIV
BLA #022575		 SUPPL-11 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
06/03/2013 HYDROXYZINE PAMOATE
ANDA #201507		 ORIG-1 HYDROXYZINE PAMOATE HERITAGE PHARMA Approval
06/03/2013 TESTOSTERONE CYPIONATE
ANDA #201720		 ORIG-1 TESTOSTERONE CYPIONATE SUN PHARM INDS LTD Approval
06/03/2013 ZIDOVUDINE
ANDA #202058		 SUPPL-3 ZIDOVUDINE HEC PHARM Labeling Approval
06/03/2013 OXAYDO
NDA #202080		 SUPPL-1 OXYCODONE HYDROCHLORIDE ZYLA Labeling Approval
06/03/2013 MORPHINE SULFATE
ANDA #202104		 ORIG-1 MORPHINE SULFATE UPSHER SMITH LABS Approval
06/03/2013 ZOLEDRONIC ACID
ANDA #202182		 ORIG-1 ZOLEDRONIC ACID HIKMA FARMACEUTICA Approval
06/03/2013 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #202884		 ORIG-2 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE APOTEX INC Approval
06/03/2013 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #202965		 ORIG-1 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE SENORES PHARMS Approval
06/03/2013 KALYDECO
NDA #203188		 SUPPL-2 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
06/03/2013 ERIVEDGE
NDA #203388		 SUPPL-2 VISMODEGIB GENENTECH Manufacturing (CMC) Approval
06/04/2013 METADATE CD
NDA #021259		 SUPPL-26 METHYLPHENIDATE HYDROCHLORIDE LANNETT Labeling Approval
06/04/2013 ZETIA
NDA #021445		 SUPPL-36 EZETIMIBE ORGANON Manufacturing (CMC) Approval
06/04/2013 MOZOBIL
NDA #022311		 SUPPL-13 PLERIXAFOR GENZYME Labeling Approval
06/04/2013 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076766		 SUPPL-7 FLUCONAZOLE BAXTER HLTHCARE Labeling Approval
06/04/2013 PREGABALIN
ANDA #201989		 ORIG-1 PREGABALIN LUPIN LTD Tentative Approval
06/04/2013 MONTELUKAST SODIUM
ANDA #202468		 SUPPL-7 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
06/05/2013 HALDOL
NDA #018701		 SUPPL-68 HALOPERIDOL DECANOATE JANSSEN PHARMS Manufacturing (CMC) Approval
06/05/2013 CLARITIN
NDA #019658		 SUPPL-40 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
06/05/2013 CLARITIN HIVES RELIEF
NDA #019658		 SUPPL-40 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
06/05/2013 AMBIEN
NDA #019908		 SUPPL-33 ZOLPIDEM TARTRATE COSETTE Manufacturing (CMC) Approval
06/05/2013 NIZORAL
NDA #019927		 SUPPL-33 KETOCONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
06/05/2013 SPORANOX
NDA #020083		 SUPPL-52 ITRACONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
06/05/2013 LOVENOX
NDA #020164		 SUPPL-100 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
06/05/2013 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-100 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
06/05/2013 UVADEX
NDA #020969		 SUPPL-5 METHOXSALEN THERAKOS DEVELOPMENT Manufacturing (CMC) Approval
06/05/2013 LANTUS
BLA #021081		 SUPPL-59 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
06/05/2013 LANTUS SOLOSTAR
BLA #021081		 SUPPL-59 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
06/05/2013 ACETADOTE
NDA #021539		 SUPPL-12 ACETYLCYSTEINE CUMBERLAND PHARMS Labeling Approval
06/05/2013 APIDRA
BLA #021629		 SUPPL-26 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
06/05/2013 APIDRA SOLOSTAR
BLA #021629		 SUPPL-26 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
06/05/2013 ALPHAGAN P
NDA #021770		 SUPPL-7 BRIMONIDINE TARTRATE ABBVIE Manufacturing (CMC) Approval
06/05/2013 REVLIMID
NDA #021880		 SUPPL-34 LENALIDOMIDE BRISTOL MYERS SQUIBB Efficacy Approval
06/05/2013 CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
NDA #065214		 SUPPL-13 CEFOXITIN SODIUM B BRAUN Labeling Approval
06/05/2013 LEVOFLOXACIN
ANDA #091436		 ORIG-1 LEVOFLOXACIN BAXTER HLTHCARE CORP Approval
06/06/2013 ALPHAGAN
NDA #020613		 SUPPL-30 BRIMONIDINE TARTRATE ALLERGAN Manufacturing (CMC) Approval
06/06/2013 SPORANOX
NDA #020657		 SUPPL-31 ITRACONAZOLE JANSSEN PHARMS Manufacturing (CMC) Approval
06/06/2013 DAYTRANA
NDA #021514		 SUPPL-15 METHYLPHENIDATE NOVEN PHARMS INC Labeling Approval
06/06/2013 BANZEL
NDA #021911		 SUPPL-10 RUFINAMIDE EISAI INC Manufacturing (CMC) Approval
06/06/2013 SOTALOL HYDROCHLORIDE
NDA #022306		 SUPPL-3 SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC Manufacturing (CMC) Approval
06/06/2013 POTIGA
NDA #022345		 SUPPL-7 EZOGABINE GLAXOSMITHKLINE Labeling Approval
06/06/2013 DIFICID
NDA #201699		 SUPPL-6 FIDAXOMICIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
06/07/2013 AMINOHIPPURATE SODIUM
NDA #005619		 SUPPL-23 AMINOHIPPURATE SODIUM MERCK Manufacturing (CMC) Approval
06/07/2013 RITALIN
NDA #010187		 SUPPL-74 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/07/2013 RITALIN-SR
NDA #018029		 SUPPL-44 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
06/07/2013 OLUX
NDA #021142		 SUPPL-18 CLOBETASOL PROPIONATE PHARMOBEDIENT Manufacturing (CMC) Approval
06/07/2013 RITALIN LA
NDA #021284		 SUPPL-19 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/07/2013 ABRAXANE
NDA #021660		 SUPPL-36 PACLITAXEL BRISTOL-MYERS Labeling Approval
06/07/2013 AMRIX
NDA #021777		 SUPPL-6 CYCLOBENZAPRINE HYDROCHLORIDE TEVA PHARMS INTL Labeling Approval
06/07/2013 AMRIX
NDA #021777		 SUPPL-9 CYCLOBENZAPRINE HYDROCHLORIDE TEVA PHARMS INTL Labeling Approval
06/07/2013 DUAC
NDA #050741		 SUPPL-20 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE STIEFEL Labeling Approval
06/07/2013 EYLEA
BLA #125387		 SUPPL-15 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
06/07/2013 EYLEA
BLA #125387		 SUPPL-20 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
06/08/2013 VIIBRYD
NDA #022567		 SUPPL-8 VILAZODONE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
06/10/2013 STIMATE
NDA #020355		 SUPPL-20 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
06/10/2013 STIMATE (NEEDS NO REFRIGERATION)
NDA #020355		 SUPPL-20 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
06/10/2013 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #021569		 SUPPL-7 SODIUM CHLORIDE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
06/10/2013 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-10 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Labeling Approval
06/10/2013 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434		 SUPPL-4 ARGATROBAN CIPLA Manufacturing (CMC) Approval
06/10/2013 DULERA
NDA #022518		 SUPPL-12 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
06/10/2013 GRALISE
NDA #022544		 SUPPL-20 GABAPENTIN ALMATICA Manufacturing (CMC) Approval
06/10/2013 TIMOLOL MALEATE
ANDA #075163		 SUPPL-1 TIMOLOL MALEATE HIKMA Labeling Approval
06/10/2013 MELOXICAM
ANDA #077932		 SUPPL-5 MELOXICAM GLENMARK PHARMS LTD Labeling Approval
06/10/2013 MELOXICAM
ANDA #077932		 SUPPL-6 MELOXICAM GLENMARK PHARMS LTD Labeling Approval
06/10/2013 MELOXICAM
ANDA #078008		 SUPPL-10 MELOXICAM AUROBINDO PHARMA Labeling Approval
06/10/2013 MELOXICAM
ANDA #078008		 SUPPL-13 MELOXICAM AUROBINDO PHARMA Labeling Approval
06/10/2013 CLOPIDOGREL BISULFATE
ANDA #078133		 ORIG-1 CLOPIDOGREL BISULFATE SUN PHARM INDUSTRIES Approval
06/10/2013 TRANDOLAPRIL
ANDA #078320		 SUPPL-1 TRANDOLAPRIL INVAGEN PHARMS Labeling Approval
06/10/2013 LOSARTAN POTASSIUM
ANDA #090428		 SUPPL-6 LOSARTAN POTASSIUM ALEMBIC PHARMS LTD Labeling Approval
06/10/2013 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-1 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Labeling Approval
06/10/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201845		 SUPPL-1 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM JUBILANT CADISTA Labeling Approval
06/10/2013 ESCITALOPRAM OXALATE
ANDA #202389		 SUPPL-1 ESCITALOPRAM OXALATE ACCORD HLTHCARE Labeling Approval
06/10/2013 CLARITHROMYCIN
ANDA #202710		 ORIG-1 CLARITHROMYCIN NOVITIUM PHARMA Approval
06/11/2013 XYLOCAINE
NDA #006488		 SUPPL-76 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
06/11/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-76 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
06/11/2013 DEXEDRINE SPANSULE
NDA #017078		 SUPPL-46 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
06/11/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-40 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
06/11/2013 PARAGARD T 380A
NDA #018680		 SUPPL-66 COPPER COOPERSURGICAL Labeling Approval
06/11/2013 ULTIVA
NDA #020630		 SUPPL-14 REMIFENTANIL HYDROCHLORIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
06/11/2013 FOCALIN
NDA #021278		 SUPPL-16 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/11/2013 AVANDAMET
NDA #021410		 SUPPL-33 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE SB PHARMCO Manufacturing (CMC) Approval
06/11/2013 MENOPUR
BLA #021663		 SUPPL-16 MENOTROPINS (FSH;LH) FERRING Approval
06/11/2013 FOCALIN XR
NDA #021802		 SUPPL-25 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
06/11/2013 NEXAVAR
NDA #021923		 SUPPL-14 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
06/11/2013 ENDOMETRIN
NDA #022057		 SUPPL-6 PROGESTERONE FERRING Manufacturing (CMC) Approval
06/11/2013 LOSARTAN POTASSIUM
ANDA #090083		 SUPPL-9 LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
06/11/2013 LOSARTAN POTASSIUM
ANDA #091541		 SUPPL-2 LOSARTAN POTASSIUM MICRO LABS Labeling Approval
06/11/2013 HYDROMORPHONE HYDROCHLORIDE
NDA #200403		 SUPPL-1 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
06/11/2013 SUPRENZA
NDA #202088		 SUPPL-5 PHENTERMINE HYDROCHLORIDE CITIUS PHARMS Labeling Approval
06/12/2013 ALDACTONE
NDA #012151		 SUPPL-71 SPIRONOLACTONE PFIZER Labeling Approval
06/12/2013 ALDACTAZIDE
NDA #012616		 SUPPL-73 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE PFIZER Labeling Approval
06/12/2013 CORDRAN
NDA #012806		 SUPPL-36 FLURANDRENOLIDE INA PHARMS Manufacturing (CMC) Approval
06/12/2013 CORDRAN SP
NDA #012806		 SUPPL-36 FLURANDRENOLIDE INA PHARMS Manufacturing (CMC) Approval
06/12/2013 HUMULIN N
BLA #018781		 SUPPL-126 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
06/12/2013 HUMULIN 70/30
BLA #019717		 SUPPL-105 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
06/12/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-105 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
06/12/2013 SURVANTA
BLA #020032		 SUPPL-42 BERACTANT ABBVIE Approval
06/12/2013 HUMALOG
BLA #020563		 SUPPL-131 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 HUMALOG KWIKPEN
BLA #020563		 SUPPL-131 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 HUMALOG PEN
BLA #020563		 SUPPL-131 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-131 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 CHILDREN'S ADVIL
NDA #020589		 SUPPL-32 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
06/12/2013 CHILDREN'S ADVIL-FLAVORED
NDA #020589		 SUPPL-32 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
06/12/2013 CYCLOSET
NDA #020866		 SUPPL-3 BROMOCRIPTINE MESYLATE VEROSCIENCE Manufacturing (CMC) Approval
06/12/2013 THYROGEN
BLA #020898		 SUPPL-56 THYROTROPIN ALFA GENZYME Approval
06/12/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-86 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-86 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-86 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2013 CONCERTA
NDA #021121		 SUPPL-31 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
06/12/2013 IMPLANON
NDA #021529		 SUPPL-9 ETONOGESTREL ORGANON Manufacturing (CMC) Approval
06/12/2013 NEXPLANON
NDA #021529		 SUPPL-9 ETONOGESTREL ORGANON Manufacturing (CMC) Approval
06/12/2013 OMNARIS
NDA #022004		 SUPPL-16 CICLESONIDE AZURITY Manufacturing (CMC) Approval
06/12/2013 BYDUREON
NDA #022200		 SUPPL-4 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
06/12/2013 BYDUREON PEN
NDA #022200		 SUPPL-4 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
06/12/2013 PREVACID 24 HR
NDA #022327		 SUPPL-21 LANSOPRAZOLE PERRIGO PHARMA INTL Manufacturing (CMC) Approval
06/12/2013 VIMOVO
NDA #022511		 SUPPL-9 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Manufacturing (CMC) Approval
06/12/2013 MELOXICAM
ANDA #077918		 SUPPL-4 MELOXICAM YUNG SHIN PHARM Labeling Approval
06/12/2013 MELOXICAM
ANDA #077923		 SUPPL-5 MELOXICAM NATCO PHARMA Labeling Approval
06/12/2013 ESCITALOPRAM OXALATE
ANDA #090477		 ORIG-1 ESCITALOPRAM OXALATE CHARTWELL MOLECULAR Approval
06/12/2013 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-1 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
06/12/2013 PANTOPRAZOLE SODIUM
ANDA #200821		 SUPPL-3 PANTOPRAZOLE SODIUM MACLEODS PHARMS LTD Labeling Approval
06/12/2013 NORETHINDRONE
ANDA #200980		 ORIG-1 NORETHINDRONE XIROMED Approval
06/12/2013 JAKAFI
NDA #202192		 SUPPL-3 RUXOLITINIB PHOSPHATE INCYTE CORP Efficacy Approval
06/13/2013 RISPERDAL
NDA #020272		 SUPPL-72 RISPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
06/13/2013 MAVIK
NDA #020528		 SUPPL-22 TRANDOLAPRIL ABBVIE Manufacturing (CMC) Approval
06/13/2013 SALONPAS
NDA #022029		 SUPPL-13 MENTHOL; METHYL SALICYLATE HISAMITSU PHARM CO Manufacturing (CMC) Approval
06/13/2013 TASIGNA
NDA #022068		 SUPPL-14 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
06/13/2013 VICTOZA
NDA #022341		 SUPPL-20 LIRAGLUTIDE NOVO NORDISK INC Labeling Approval
06/13/2013 ISTODAX
NDA #022393		 SUPPL-11 ROMIDEPSIN BRISTOL-MYERS Labeling Approval
06/13/2013 KETAMINE HYDROCHLORIDE
ANDA #074549		 SUPPL-15 KETAMINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/13/2013 CARBAMAZEPINE
ANDA #074649		 SUPPL-23 CARBAMAZEPINE TARO Labeling Approval
06/13/2013 CARBAMAZEPINE
ANDA #075687		 SUPPL-17 CARBAMAZEPINE TARO PHARM INDS Labeling Approval
06/13/2013 TERIL
ANDA #076729		 SUPPL-9 CARBAMAZEPINE TARO Labeling Approval
06/13/2013 CARVEDILOL
ANDA #077316		 SUPPL-6 CARVEDILOL ALLIED Labeling Approval
06/13/2013 MELOXICAM
ANDA #077927		 SUPPL-14 MELOXICAM UNICHEM Labeling Approval
06/13/2013 MELOXICAM
ANDA #077936		 SUPPL-14 MELOXICAM CHARTWELL RX Labeling Approval
06/13/2013 CARBAMAZEPINE
ANDA #078115		 SUPPL-7 CARBAMAZEPINE TARO Labeling Approval
06/13/2013 ROCURONIUM BROMIDE
ANDA #078519		 SUPPL-11 ROCURONIUM BROMIDE HOSPIRA Labeling Approval
06/13/2013 PROLIA
BLA #125320		 SUPPL-94 DENOSUMAB AMGEN Approval
06/13/2013 XGEVA
BLA #125320		 SUPPL-94 DENOSUMAB AMGEN Approval
06/13/2013 MYCOPHENOLATE MOFETIL
ANDA #200197		 ORIG-1 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Approval
06/13/2013 LATUDA
NDA #200603		 SUPPL-12 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Manufacturing (CMC) Approval
06/13/2013 RAYOS
NDA #202020		 SUPPL-3 PREDNISONE HORIZON Labeling Approval
06/13/2013 PANTOPRAZOLE SODIUM
ANDA #202038		 SUPPL-2 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
06/13/2013 PANTOPRAZOLE SODIUM
ANDA #202038		 SUPPL-3 PANTOPRAZOLE SODIUM AUROBINDO PHARMA LTD Labeling Approval
06/13/2013 CLONIDINE HYDROCHLORIDE
ANDA #202297		 ORIG-1 CLONIDINE HYDROCHLORIDE YUNG SHIN PHARM Approval
06/14/2013 ALDACTAZIDE
NDA #012616		 SUPPL-72 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE PFIZER Manufacturing (CMC) Approval
06/14/2013 DESFERAL
NDA #016267		 SUPPL-51 DEFEROXAMINE MESYLATE MITEM PHARMA Manufacturing (CMC) Approval
06/14/2013 DEPAKENE
NDA #018081		 SUPPL-57 VALPROIC ACID ABBVIE Labeling Approval
06/14/2013 DEPAKENE
NDA #018082		 SUPPL-40 VALPROIC ACID ABBVIE Labeling Approval
06/14/2013 DEPAKOTE
NDA #018723		 SUPPL-49 DIVALPROEX SODIUM ABBVIE Labeling Approval
06/14/2013 DEPAKOTE
NDA #019680		 SUPPL-36 DIVALPROEX SODIUM ABBVIE Labeling Approval
06/14/2013 DEPACON
NDA #020593		 SUPPL-27 VALPROATE SODIUM ABBVIE Labeling Approval
06/14/2013 URSO 250
NDA #020675		 SUPPL-22 URSODIOL ABBVIE Labeling Approval
06/14/2013 URSO FORTE
NDA #020675		 SUPPL-22 URSODIOL ABBVIE Labeling Approval
06/14/2013 DEPAKOTE ER
NDA #021168		 SUPPL-25 DIVALPROEX SODIUM ABBVIE Labeling Approval
06/14/2013 ADDERALL XR 10
NDA #021303		 SUPPL-24 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 ADDERALL XR 15
NDA #021303		 SUPPL-24 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 ADDERALL XR 20
NDA #021303		 SUPPL-24 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 ADDERALL XR 25
NDA #021303		 SUPPL-24 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 ADDERALL XR 30
NDA #021303		 SUPPL-24 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 ADDERALL XR 5
NDA #021303		 SUPPL-24 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 METHYLIN
NDA #021419		 SUPPL-6 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/14/2013 METHYLIN
NDA #021475		 SUPPL-6 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/14/2013 MEGACE ES
NDA #021778		 SUPPL-14 MEGESTROL ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
06/14/2013 ROZEREM
NDA #021782		 SUPPL-16 RAMELTEON TAKEDA PHARMS USA Manufacturing (CMC) Approval
06/14/2013 PREZISTA
NDA #021976		 SUPPL-31 DARUNAVIR JANSSEN PRODS Manufacturing (CMC) Approval
06/14/2013 VYVANSE
NDA #021977		 SUPPL-28 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
06/14/2013 STAVZOR
NDA #022152		 SUPPL-5 VALPROIC ACID BIONPHARMA Labeling Approval
06/14/2013 INTERMEZZO
NDA #022328		 SUPPL-2 ZOLPIDEM TARTRATE PURDUE PHARMA Manufacturing (CMC) Approval
06/14/2013 LAMOTRIGINE
ANDA #200694		 ORIG-1 LAMOTRIGINE ALKEM LABS LTD Approval
06/14/2013 TRANEXAMIC ACID
ANDA #201580		 ORIG-1 TRANEXAMIC ACID XGEN PHARMS Approval
06/14/2013 OXTELLAR XR
NDA #202810		 SUPPL-1 OXCARBAZEPINE SUPERNUS PHARMS Manufacturing (CMC) Approval
06/14/2013 PREZISTA
NDA #202895		 SUPPL-8 DARUNAVIR JANSSEN PRODS Manufacturing (CMC) Approval
06/16/2013 NITROUS OXIDE, USP
NDA #205704		 ORIG-1 NITROUS OXIDE AIR LIQUIDE AMERICA SPECIALITY GASES Medical Gas Approval
06/16/2013 MEDICAL AIR, USP
NDA #205711		 ORIG-1 MEDICAL AIR AIR LIQUIDE AMERICA SPECIALITY GASES Medical Gas Approval
06/16/2013 OXYGEN, USP
NDA #205712		 ORIG-1 OXYGEN AIR LIQUID INDUSTRIAL US LP Medical Gas Approval
06/16/2013 OXYGEN, USP
NDA #205713		 ORIG-1 OXYGEN AIR LIQUID INDUSTRIAL US LP Medical Gas Approval
06/17/2013 LAMISIL
NDA #020539		 SUPPL-23 TERBINAFINE HYDROCHLORIDE NOVARTIS Labeling Approval
06/17/2013 CELEXA
NDA #020822		 SUPPL-44 CITALOPRAM HYDROBROMIDE ABBVIE Manufacturing (CMC) Approval
06/17/2013 PRECEDEX
NDA #021038		 SUPPL-21 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Efficacy Approval
06/17/2013 PRECEDEX
NDA #021038		 SUPPL-22 DEXMEDETOMIDINE HYDROCHLORIDE HOSPIRA Efficacy Approval
06/17/2013 NEXIUM
NDA #021153		 SUPPL-45 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA Manufacturing (CMC) Approval
06/17/2013 ISTALOL
NDA #021516		 SUPPL-5 TIMOLOL MALEATE BAUSCH AND LOMB Labeling Approval
06/17/2013 ELESTAT
NDA #021565		 SUPPL-7 EPINASTINE HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
06/17/2013 TRUVADA
NDA #021752		 SUPPL-35 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Labeling Approval
06/17/2013 TRUVADA
NDA #021752		 SUPPL-36 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
06/17/2013 SPRYCEL
NDA #021986		 SUPPL-13 DASATINIB BRISTOL MYERS SQUIBB Efficacy Approval
06/17/2013 INVEGA
NDA #021999		 SUPPL-28 PALIPERIDONE JANSSEN PHARMS Manufacturing (CMC) Approval
06/17/2013 LAMISIL
NDA #022071		 SUPPL-9 TERBINAFINE HYDROCHLORIDE NOVARTIS Labeling Approval
06/17/2013 ZEGERID OTC
NDA #022283		 ORIG-1 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Type 8 - Partial Rx to OTC Switch Approval
06/17/2013 CODEINE SULFATE
NDA #022402		 SUPPL-5 CODEINE SULFATE HIKMA Manufacturing (CMC) Approval
06/17/2013 CYCLOPHOSPHAMIDE
ANDA #040745		 SUPPL-2 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
06/17/2013 AZACTAM
NDA #050580		 SUPPL-42 AZTREONAM LABS DELBERT Labeling Approval
06/17/2013 AZACTAM IN PLASTIC CONTAINER
NDA #050632		 SUPPL-15 AZTREONAM BRISTOL MYERS SQUIBB Labeling Approval
06/17/2013 MINOCYCLINE HYDROCHLORIDE
ANDA #063011		 SUPPL-35 MINOCYCLINE HYDROCHLORIDE ZYDUS Labeling Approval
06/17/2013 BLEOMYCIN SULFATE
ANDA #065031		 SUPPL-12 BLEOMYCIN SULFATE HOSPIRA Labeling Approval
06/17/2013 PACERONE
ANDA #075135		 SUPPL-43 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
06/17/2013 PACERONE
ANDA #075135		 SUPPL-44 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
06/17/2013 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078252		 SUPPL-13 CIPROFLOXACIN INFORLIFE Labeling Approval
06/17/2013 U-CORT
ANDA #089472		 SUPPL-23 HYDROCORTISONE ACETATE SUN PHARMA CANADA Labeling Approval
06/17/2013 ZYTIGA
NDA #202379		 SUPPL-6 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
06/17/2013 LAMOTRIGINE
ANDA #202887		 ORIG-1 LAMOTRIGINE RUBICON RESEARCH Approval
06/18/2013 ZOLADEX
NDA #019726		 SUPPL-56 GOSERELIN ACETATE TERSERA Labeling Approval
06/18/2013 ZOLADEX
NDA #019726		 SUPPL-57 GOSERELIN ACETATE TERSERA Labeling Approval
06/18/2013 SULFAMYLON
NDA #019832		 SUPPL-13 MAFENIDE ACETATE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
06/18/2013 NIASPAN
NDA #020381		 SUPPL-49 NIACIN ABBVIE Manufacturing (CMC) Approval
06/18/2013 NIASPAN TITRATION STARTER PACK
NDA #020381		 SUPPL-49 NIACIN ABBVIE Manufacturing (CMC) Approval
06/18/2013 ZOLADEX
NDA #020578		 SUPPL-34 GOSERELIN ACETATE TERSERA Labeling Approval
06/18/2013 ZOLADEX
NDA #020578		 SUPPL-35 GOSERELIN ACETATE TERSERA Labeling Approval
06/18/2013 OMNITROPE
BLA #021426		 SUPPL-25 SOMATROPIN SANDOZ Approval
06/18/2013 BARACLUDE
NDA #021797		 SUPPL-16 ENTECAVIR BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
06/18/2013 BARACLUDE
NDA #021798		 SUPPL-17 ENTECAVIR BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
06/18/2013 AMPYRA
NDA #022250		 SUPPL-8 DALFAMPRIDINE MERZ REMS Approval
06/18/2013 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-28 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/18/2013 RILUZOLE
ANDA #091300		 ORIG-1 RILUZOLE APOTEX CORP Approval
06/18/2013 RILUZOLE
ANDA #091394		 ORIG-1 RILUZOLE GLENMARK PHARMS LTD Approval
06/18/2013 RILUZOLE
ANDA #091417		 ORIG-1 RILUZOLE SUN PHARM INDS LTD Approval
06/18/2013 TRADJENTA
NDA #201280		 SUPPL-6 LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
06/18/2013 JENTADUETO
NDA #201281		 SUPPL-3 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
06/19/2013 FELDENE
NDA #018147		 SUPPL-41 PIROXICAM PFIZER Manufacturing (CMC) Approval
06/19/2013 FLONASE
NDA #020121		 SUPPL-41 FLUTICASONE PROPIONATE HALEON US HOLDINGS Manufacturing (CMC) Approval
06/19/2013 TRELSTAR
NDA #020715		 SUPPL-29 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
06/19/2013 FLOVENT DISKUS 100
NDA #020833		 SUPPL-27 FLUTICASONE PROPIONATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 FLOVENT DISKUS 250
NDA #020833		 SUPPL-27 FLUTICASONE PROPIONATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 FLOVENT DISKUS 50
NDA #020833		 SUPPL-27 FLUTICASONE PROPIONATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 ADVAIR DISKUS 100/50
NDA #021077		 SUPPL-50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 ADVAIR DISKUS 250/50
NDA #021077		 SUPPL-50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 ADVAIR DISKUS 500/50
NDA #021077		 SUPPL-50 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 ADVAIR HFA
NDA #021254		 SUPPL-20 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 FLOVENT HFA
NDA #021433		 SUPPL-21 FLUTICASONE PROPIONATE GLAXO GRP LTD Manufacturing (CMC) Approval
06/19/2013 SUPPRELIN LA
NDA #022058		 SUPPL-8 HISTRELIN ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
06/19/2013 CLEOCIN
NDA #050767		 SUPPL-10 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
06/19/2013 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #200674		 ORIG-1 LEVOFLOXACIN FRESENIUS KABI USA Approval
06/19/2013 LAMOTRIGINE
ANDA #202383		 ORIG-1 LAMOTRIGINE DR REDDYS LABS LTD Approval
06/19/2013 STRIBILD
NDA #203100		 SUPPL-5 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
06/20/2013 NIPENT
NDA #020122		 SUPPL-12 PENTOSTATIN HOSPIRA INC Manufacturing (CMC) Approval
06/20/2013 PLAN B ONE-STEP
NDA #021998		 SUPPL-3 LEVONORGESTREL FDN CONSUMER Efficacy Approval
06/20/2013 NAMENDA XR
NDA #022525		 SUPPL-2 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
06/20/2013 EPIRUBICIN HYDROCHLORIDE
NDA #050807		 SUPPL-2 EPIRUBICIN HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
06/20/2013 GEMCITABINE HYDROCHLORIDE
NDA #200795		 SUPPL-2 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
06/20/2013 COMPLERA
NDA #202123		 SUPPL-11 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
06/21/2013 CALCIUM DISODIUM VERSENATE
NDA #008922		 SUPPL-18 EDETATE CALCIUM DISODIUM BAUSCH Manufacturing (CMC) Approval
06/21/2013 KENALOG
NDA #012104		 SUPPL-34 TRIAMCINOLONE ACETONIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
06/21/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-36 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
06/21/2013 ORFADIN
NDA #021232		 SUPPL-12 NITISINONE SWEDISH ORPHAN Manufacturing (CMC) Approval
06/21/2013 MYCAMINE
NDA #021506		 SUPPL-15 MICAFUNGIN SODIUM ASTELLAS Efficacy Approval
06/21/2013 TYKERB
NDA #022059		 SUPPL-15 LAPATINIB DITOSYLATE NOVARTIS Labeling Approval
06/21/2013 TYKERB
NDA #022059		 SUPPL-18 LAPATINIB DITOSYLATE NOVARTIS Labeling Approval
06/21/2013 VIBATIV
NDA #022110		 SUPPL-3 TELAVANCIN HYDROCHLORIDE CUMBERLAND REMS Approval
06/21/2013 AFINITOR
NDA #022334		 SUPPL-20 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
06/21/2013 VIBATIV
NDA #022407		 ORIG-1 TELAVANCIN THERAVANCE INC Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
06/21/2013 DOCEFREZ
NDA #022534		 SUPPL-3 DOCETAXEL SUN PHARM Manufacturing (CMC) Approval
06/21/2013 DOCETAXEL
NDA #022534		 SUPPL-3 DOCETAXEL SUN PHARM Manufacturing (CMC) Approval
06/21/2013 VANTIN
NDA #050674		 SUPPL-15 CEFPODOXIME PROXETIL PFIZER Labeling Approval
06/21/2013 VANTIN
NDA #050675		 SUPPL-18 CEFPODOXIME PROXETIL PFIZER Labeling Approval
06/21/2013 BLEOMYCIN SULFATE
ANDA #065033		 SUPPL-23 BLEOMYCIN SULFATE TEVA PHARMS USA Labeling Approval
06/21/2013 AZITHROMYCIN
ANDA #065153		 SUPPL-15 AZITHROMYCIN TEVA Labeling Approval
06/21/2013 AZITHROMYCIN
ANDA #065193		 SUPPL-15 AZITHROMYCIN TEVA Labeling Approval
06/21/2013 NIMODIPINE
ANDA #077811		 SUPPL-1 NIMODIPINE HERITAGE Labeling Approval
06/21/2013 CARBAMAZEPINE
ANDA #201106		 ORIG-1 CARBAMAZEPINE TARO Approval
06/21/2013 EDURANT
NDA #202022		 SUPPL-5 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Labeling Approval
06/21/2013 METAXALONE
ANDA #203399		 ORIG-1 METAXALONE AMNEAL PHARMS Approval
06/23/2013 OXYGEN, USP
NDA #205737		 ORIG-1 OXYGEN AIR LIQUIDE LARGE INDUSTRIES US LP Medical Gas Approval
06/23/2013 NITROGEN, NF
NDA #205738		 ORIG-1 NITROGEN AIR LIQUIDE LARGE INDUSTRIES US LP Medical Gas Approval
06/24/2013 RAPAFLO
NDA #022206		 SUPPL-11 SILODOSIN ABBVIE Manufacturing (CMC) Approval
06/24/2013 DOXORUBICIN HYDROCHLORIDE
ANDA #064140		 SUPPL-27 DOXORUBICIN HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
06/24/2013 ELAPRASE
BLA #125151		 SUPPL-152 IDURSULFASE SHIRE Approval
06/24/2013 ELAPRASE
BLA #125151		 SUPPL-184 IDURSULFASE SHIRE Approval
06/24/2013 NORETHINDRONE
ANDA #201483		 ORIG-1 NORETHINDRONE XIROMED Approval
06/25/2013 THAM
NDA #013025		 SUPPL-54 TROMETHAMINE HOSPIRA Manufacturing (CMC) Approval
06/25/2013 THAM-E
NDA #013025		 SUPPL-54 POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE HOSPIRA Manufacturing (CMC) Approval
06/25/2013 LESCOL
NDA #020261		 SUPPL-47 FLUVASTATIN SODIUM NOVARTIS Manufacturing (CMC) Approval
06/25/2013 LESCOL XL
NDA #021192		 SUPPL-20 FLUVASTATIN SODIUM SANDOZ Manufacturing (CMC) Approval
06/25/2013 SAVELLA
NDA #022256		 SUPPL-16 MILNACIPRAN HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
06/25/2013 AZITHROMYCIN
ANDA #065209		 SUPPL-19 AZITHROMYCIN SANDOZ Labeling Approval
06/25/2013 AZITHROMYCIN
ANDA #065211		 SUPPL-22 AZITHROMYCIN SANDOZ Labeling Approval
06/25/2013 AZITHROMYCIN
ANDA #065212		 SUPPL-20 AZITHROMYCIN SANDOZ Labeling Approval
06/25/2013 MONTELUKAST SODIUM
ANDA #078605		 SUPPL-5 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
06/25/2013 MONTELUKAST SODIUM
ANDA #078723		 SUPPL-5 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
06/25/2013 ICLUSIG
NDA #203469		 SUPPL-2 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
06/26/2013 COGENTIN
NDA #012015		 SUPPL-31 BENZTROPINE MESYLATE EPIC PHARMA LLC Manufacturing (CMC) Approval
06/26/2013 RIMSO-50
NDA #017788		 SUPPL-21 DIMETHYL SULFOXIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
06/26/2013 TAXOTERE
NDA #020449		 SUPPL-69 DOCETAXEL SANOFI AVENTIS US Labeling Approval
06/26/2013 CUBICIN
NDA #021572		 SUPPL-42 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
06/26/2013 CUBICIN RF
NDA #021572		 SUPPL-42 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
06/26/2013 METHADONE HYDROCHLORIDE
NDA #021624		 SUPPL-5 METHADONE HYDROCHLORIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
06/26/2013 LOVAZA
NDA #021654		 SUPPL-37 OMEGA-3-ACID ETHYL ESTERS WAYLIS THERAP Labeling Approval
06/26/2013 NESINA
NDA #022271		 SUPPL-2 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
06/26/2013 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-25 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
06/26/2013 AZITHROMYCIN
ANDA #065223		 SUPPL-17 AZITHROMYCIN PLIVA Labeling Approval
06/26/2013 AZITHROMYCIN
ANDA #065225		 SUPPL-20 AZITHROMYCIN PLIVA Labeling Approval
06/26/2013 AZITHROMYCIN
ANDA #065419		 SUPPL-10 AZITHROMYCIN TEVA PHARMS Labeling Approval
06/26/2013 AZITHROMYCIN
ANDA #065506		 SUPPL-9 AZITHROMYCIN PHARMOBEDIENT Labeling Approval
06/26/2013 AZITHROMYCIN
ANDA #065508		 SUPPL-1 AZITHROMYCIN APOTEX CORP Labeling Approval
06/26/2013 MONTELUKAST SODIUM
ANDA #090955		 SUPPL-5 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
06/26/2013 MONTELUKAST SODIUM
ANDA #091414		 SUPPL-6 MONTELUKAST SODIUM AIPING PHARM INC Labeling Approval
06/26/2013 LEVETIRACETAM
ANDA #091627		 ORIG-1 LEVETIRACETAM SAGENT PHARMS Approval
06/26/2013 MONTELUKAST SODIUM
ANDA #200889		 SUPPL-6 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
06/26/2013 TOPOTECAN HYDROCHLORIDE
ANDA #202351		 ORIG-1 TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE Approval
06/27/2013 M.V.I. PEDIATRIC
NDA #018920		 SUPPL-34 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
06/27/2013 ACTOS
NDA #021073		 SUPPL-47 PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
06/27/2013 EXELON
NDA #022083		 SUPPL-19 RIVASTIGMINE SANDOZ Efficacy Approval
06/27/2013 TIMENTIN
ANDA #062691		 SUPPL-53 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Labeling Approval
06/27/2013 TIMENTIN
ANDA #062691		 SUPPL-54 CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM GLAXOSMITHKLINE Labeling Approval
06/27/2013 AZITHROMYCIN
ANDA #065179		 SUPPL-11 AZITHROMYCIN FRESENIUS KABI USA Labeling Approval
06/27/2013 RIFAMPIN
ANDA #065390		 SUPPL-5 RIFAMPIN CHARTWELL MOLECULAR Labeling Approval
06/27/2013 AZITHROMYCIN
ANDA #065507		 SUPPL-1 AZITHROMYCIN APOTEX CORP Labeling Approval
06/27/2013 AZITHROMYCIN
ANDA #065509		 SUPPL-1 AZITHROMYCIN APOTEX CORP Labeling Approval
06/27/2013 FAMOTIDINE
ANDA #075704		 SUPPL-15 FAMOTIDINE RISING Labeling Approval
06/27/2013 FAMCICLOVIR
ANDA #077487		 SUPPL-7 FAMCICLOVIR TEVA PHARMS Labeling Approval
06/27/2013 RISPERIDONE
ANDA #077719		 SUPPL-4 RISPERIDONE PHARM ASSOC Labeling Approval
06/27/2013 HYDROXYZINE PAMOATE
ANDA #087479		 SUPPL-31 HYDROXYZINE PAMOATE SANDOZ Labeling Approval
06/27/2013 DONEPEZIL HYDROCHLORIDE
ANDA #090425		 SUPPL-2 DONEPEZIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/27/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #091238		 SUPPL-4 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL MOLECULAR Labeling Approval
06/27/2013 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #091238		 SUPPL-5 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL MOLECULAR Labeling Approval
06/27/2013 WARFARIN SODIUM
ANDA #200104		 ORIG-1 WARFARIN SODIUM AIPING PHARM INC Approval
06/27/2013 FLUDEOXYGLUCOSE F18
ANDA #203811		 ORIG-1 FLUDEOXYGLUCOSE F-18 UCLA BIOMEDICAL Approval
06/27/2013 AMMONIA N 13
ANDA #203812		 ORIG-1 AMMONIA N-13 UCLA BIOMEDICAL Approval
06/27/2013 NAFTIN
NDA #204286		 ORIG-1 NAFTIFINE HYDROCHLORIDE LEGACY Type 5 - New Formulation or New Manufacturer Approval
06/28/2013 METOPIRONE
NDA #012911		 SUPPL-31 METYRAPONE ESTEVE Manufacturing (CMC) Approval
06/28/2013 LOPROX
NDA #018748		 SUPPL-24 CICLOPIROX EUROFARMA Labeling Approval
06/28/2013 LOPROX
NDA #019824		 SUPPL-23 CICLOPIROX EUROFARMA Labeling Approval
06/28/2013 CICLOPIROX
NDA #020519		 SUPPL-16 CICLOPIROX ALVOGEN Labeling Approval
06/28/2013 RAZADYNE
NDA #021169		 SUPPL-24 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
06/28/2013 WELCHOL
NDA #021176		 SUPPL-34 COLESEVELAM HYDROCHLORIDE COSETTE Efficacy Approval
06/28/2013 WELCHOL
NDA #021176		 SUPPL-38 COLESEVELAM HYDROCHLORIDE COSETTE Labeling Approval
06/28/2013 RAZADYNE
NDA #021224		 SUPPL-22 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
06/28/2013 RAZADYNE ER
NDA #021615		 SUPPL-16 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
06/28/2013 NUVIGIL
NDA #021875		 SUPPL-12 ARMODAFINIL NUVO PHARMS Labeling Approval
06/28/2013 JANUMET
NDA #022044		 SUPPL-28 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
06/28/2013 ISENTRESS
NDA #022145		 SUPPL-27 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
06/28/2013 ISENTRESS HD
NDA #022145		 SUPPL-27 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
06/28/2013 TACLONEX
NDA #022185		 SUPPL-14 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
06/28/2013 TACLONEX
NDA #022185		 SUPPL-14 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
06/28/2013 WELCHOL
NDA #022362		 SUPPL-15 COLESEVELAM HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
06/28/2013 WELCHOL
NDA #022362		 SUPPL-17 COLESEVELAM HYDROCHLORIDE COSETTE Labeling Approval
06/28/2013 WELCHOL
NDA #022362		 SUPPL-18 COLESEVELAM HYDROCHLORIDE COSETTE Labeling Approval
06/28/2013 PRIMAXIN
ANDA #062756		 SUPPL-55 CILASTATIN SODIUM; IMIPENEM MERCK Labeling Approval
06/28/2013 AMPICILLIN SODIUM
ANDA #063142		 SUPPL-10 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
06/28/2013 AMPICILLIN AND SULBACTAM
ANDA #065188		 SUPPL-9 AMPICILLIN SODIUM; SULBACTAM SODIUM HQ SPECLT PHARMA Labeling Approval
06/28/2013 AMIODARONE HYDROCHLORIDE
ANDA #075315		 SUPPL-29 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
06/28/2013 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #076915		 SUPPL-11 DESOGESTREL; ETHINYL ESTRADIOL WATSON LABS Labeling Approval
06/28/2013 BETASERON
BLA #103471		 SUPPL-5125 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
06/28/2013 LATUDA
NDA #200603		 SUPPL-10 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Efficacy Approval
06/28/2013 LATUDA
NDA #200603		 SUPPL-11 LURASIDONE HYDROCHLORIDE SUNOVION PHARMS INC Efficacy Approval
06/28/2013 IMIPRAMINE PAMOATE
ANDA #202338		 ORIG-1 IMIPRAMINE PAMOATE RISING Approval
06/28/2013 ISENTRESS
NDA #203045		 SUPPL-4 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
06/28/2013 SODIUM FLUORIDE F-18
ANDA #203605		 ORIG-1 SODIUM FLUORIDE F-18 MCPRF Approval
06/28/2013 BRISDELLE
NDA #204516		 ORIG-1 PAROXETINE MESYLATE LEGACY Type 3 - New Dosage Form Approval
06/29/2013 ONDANSETRON HYDROCHLORIDE
ANDA #078127		 SUPPL-4 ONDANSETRON HYDROCHLORIDE PHARM ASSOC Labeling Approval
06/30/2013 OMEPRAZOLE
ANDA #076048		 SUPPL-11 OMEPRAZOLE APOTEX Labeling Approval
06/30/2013 OMEPRAZOLE
ANDA #076048		 SUPPL-12 OMEPRAZOLE APOTEX Labeling Approval
06/30/2013 ONDANSETRON HYDROCHLORIDE
ANDA #079224		 SUPPL-2 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
06/30/2013 ONDANSETRON HYDROCHLORIDE
ANDA #079224		 SUPPL-4 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
06/30/2013 ONDANSETRON HYDROCHLORIDE
ANDA #090648		 SUPPL-1 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
06/30/2013 ONDANSETRON HYDROCHLORIDE
ANDA #090648		 SUPPL-3 ONDANSETRON HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
06/30/2013 FYCOMPA
NDA #202834		 SUPPL-1 PERAMPANEL CATALYST PHARMS Labeling Approval
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