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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 2015

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 December 08, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/03/2015 GUANIDINE HYDROCHLORIDE
NDA #001546		 SUPPL-22 GUANIDINE HYDROCHLORIDE MERCK SHARP DOHME Manufacturing (CMC) Approval
08/03/2015 LOVENOX
NDA #020164		 SUPPL-106 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
08/03/2015 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-106 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
08/03/2015 COPAXONE
NDA #020622		 SUPPL-94 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
08/03/2015 ASMANEX TWISTHALER
NDA #021067		 SUPPL-24 MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
08/03/2015 IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140		 SUPPL-22 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE J AND J CONSUMER INC Manufacturing (CMC) Approval
08/03/2015 ZYRTEC-D 12 HOUR
NDA #021150		 SUPPL-12 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
08/03/2015 CUBICIN
NDA #021572		 SUPPL-48 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
08/03/2015 CUBICIN RF
NDA #021572		 SUPPL-48 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
08/03/2015 IBUPROFEN
ANDA #072199		 SUPPL-39 IBUPROFEN AMNEAL PHARMS NY Manufacturing (CMC) Approval
08/03/2015 IBUPROFEN
ANDA #072199		 SUPPL-41 IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/03/2015 ESOMEPRAZOLE MAGNESIUM
ANDA #078936		 ORIG-1 ESOMEPRAZOLE MAGNESIUM MYLAN Approval
08/03/2015 LYMPHOSEEK KIT
NDA #202207		 SUPPL-4 TECHNETIUM TC-99M TILMANOCEPT CARDINAL HEALTH 414 Manufacturing (CMC) Approval
08/03/2015 PALIPERIDONE
ANDA #202645		 ORIG-1 PALIPERIDONE ACTAVIS LABS FL INC Approval
08/03/2015 ASMANEX HFA
NDA #205641		 SUPPL-4 MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
08/03/2015 HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #205657		 ORIG-1 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE MAYNE PHARMA INC Approval
08/03/2015 IBUPROFEN SODIUM
ANDA #206581		 ORIG-1 IBUPROFEN SODIUM PERRIGO R AND D Approval
08/04/2015 PHENERGAN
NDA #010926		 SUPPL-31 PROMETHAZINE HYDROCHLORIDE NORVIUM BIOSCIENCE Manufacturing (CMC) Approval
08/04/2015 PHENERGAN
NDA #011689		 SUPPL-25 PROMETHAZINE HYDROCHLORIDE NORVIUM BIOSCIENCE Manufacturing (CMC) Approval
08/04/2015 DEPOCYT
NDA #021041		 SUPPL-34 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
08/04/2015 PROZAC WEEKLY
NDA #021235		 SUPPL-25 FLUOXETINE HYDROCHLORIDE LILLY Labeling Approval
08/04/2015 GELNIQUE
NDA #022204		 SUPPL-8 OXYBUTYNIN CHLORIDE ABBVIE Manufacturing (CMC) Approval
08/04/2015 MOZOBIL
NDA #022311		 SUPPL-16 PLERIXAFOR GENZYME Labeling Approval
08/04/2015 GILENYA
NDA #022527		 SUPPL-19 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
08/04/2015 MYFORTIC
NDA #050791		 SUPPL-21 MYCOPHENOLIC SODIUM NOVARTIS Manufacturing (CMC) Approval
08/04/2015 VASCEPA
NDA #202057		 SUPPL-13 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
08/04/2015 TINIDAZOLE
ANDA #203808		 ORIG-1 TINIDAZOLE EDENBRIDGE PHARMS Approval
08/04/2015 TESTOSTERONE
ANDA #204268		 ORIG-1 TESTOSTERONE PADAGIS ISRAEL Approval
08/04/2015 AURYXIA
NDA #205874		 SUPPL-6 FERRIC CITRATE KERYX BIOPHARMS Manufacturing (CMC) Approval
08/05/2015 CHG SCRUB
NDA #019258		 SUPPL-21 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
08/05/2015 CIDA-STAT
NDA #019258		 SUPPL-21 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
08/05/2015 PENTASA
NDA #020049		 SUPPL-27 MESALAMINE TAKEDA PHARMS USA Labeling Approval
08/05/2015 THALOMID
NDA #020785		 SUPPL-51 THALIDOMIDE BRISTOL-MYERS Labeling Approval
08/05/2015 MICARDIS
NDA #020850		 SUPPL-39 TELMISARTAN BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
08/05/2015 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434		 SUPPL-7 ARGATROBAN CIPLA Manufacturing (CMC) Approval
08/05/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #079108		 ORIG-3 DEXMETHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Approval
08/05/2015 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #090760		 ORIG-1 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/05/2015 CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #090760		 ORIG-1 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/05/2015 BOTOX
BLA #103000		 SUPPL-5244 OnabotulinumtoxinA ALLERGAN Approval
08/05/2015 BOTOX COSMETIC
BLA #103000		 SUPPL-5244 OnabotulinumtoxinA ALLERGAN Approval
08/05/2015 SIMPONI ARIA
BLA #125433		 SUPPL-14 GOLIMUMAB JANSSEN BIOTECH Approval
08/05/2015 XTANDI
NDA #203415		 SUPPL-6 ENZALUTAMIDE ASTELLAS Labeling Approval
08/05/2015 TESTOSTERONE
ANDA #204571		 ORIG-1 TESTOSTERONE ACTAVIS LABS UT INC Approval
08/05/2015 TIVICAY
NDA #204790		 SUPPL-5 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Labeling Approval
08/05/2015 TRIUMEQ
NDA #205551		 SUPPL-2 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Labeling Approval
08/06/2015 SOLU-MEDROL
NDA #011856		 SUPPL-127 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
08/06/2015 BIO-TROPIN
BLA #019774		 SUPPL-30 SOMATROPIN FERRING Approval
08/06/2015 ZOMACTON
BLA #019774		 SUPPL-30 SOMATROPIN FERRING Approval
08/06/2015 NICODERM CQ
NDA #020165		 SUPPL-35 NICOTINE CHATTEM SANOFI Labeling Approval
08/06/2015 CLIMARA
NDA #020375		 SUPPL-31 ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
08/06/2015 MENOSTAR
NDA #020375		 SUPPL-31 ESTRADIOL BAYER HLTHCARE Manufacturing (CMC) Approval
08/06/2015 DULERA
NDA #022518		 SUPPL-16 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
08/06/2015 VARITHENA
NDA #205098		 SUPPL-10 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
08/06/2015 ASMANEX HFA
NDA #205641		 SUPPL-1 MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
08/07/2015 DARANIDE
NDA #011366		 SUPPL-30 DICHLORPHENAMIDE XERIS Efficacy Approval
08/07/2015 KEVEYIS
NDA #011366		 SUPPL-30 DICHLORPHENAMIDE XERIS Efficacy Approval
08/07/2015 TECHNETIUM TC 99M GENERATOR
NDA #017693		 SUPPL-29 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR GE HEALTHCARE Labeling Approval
08/07/2015 FUROSEMIDE
NDA #018413		 SUPPL-62 FUROSEMIDE CHARTWELL RX Manufacturing (CMC) Approval
08/07/2015 XENICAL
NDA #020766		 SUPPL-35 ORLISTAT CHEPLAPHARM Labeling Approval
08/07/2015 PRIFTIN
NDA #021024		 SUPPL-12 RIFAPENTINE SANOFI AVENTIS US Manufacturing (CMC) Approval
08/07/2015 IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140		 SUPPL-19 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE J AND J CONSUMER INC Manufacturing (CMC) Approval
08/07/2015 SYMLIN
NDA #021332		 SUPPL-24 PRAMLINTIDE ACETATE ASTRAZENECA AB REMS Approval
08/07/2015 OMEPRAZOLE
NDA #022032		 SUPPL-26 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
08/07/2015 ZIPSOR
NDA #022202		 SUPPL-8 DICLOFENAC POTASSIUM ASSERTIO Manufacturing (CMC) Approval
08/07/2015 LIDOCAINE
ANDA #202346		 ORIG-1 LIDOCAINE MYLAN TECHNOLOGIES Approval
08/07/2015 NYMALIZE
NDA #203340		 SUPPL-2 NIMODIPINE AZURITY Manufacturing (CMC) Approval
08/07/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203354		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE DR REDDYS Approval
08/07/2015 ANORO ELLIPTA
NDA #203975		 SUPPL-1 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Manufacturing (CMC) Approval
08/07/2015 AMILORIDE HYDROCHLORIDE
ANDA #204180		 ORIG-1 AMILORIDE HYDROCHLORIDE CHARTWELL RX Approval
08/07/2015 LIDOCAINE
ANDA #206297		 ORIG-1 LIDOCAINE AMNEAL PHARMS Approval
08/07/2015 CEFAZOLIN IN DEXTROSE
NDA #207131		 ORIG-1 CEFAZOLIN SODIUM BAXTER HLTHCARE CORP Type 5 - New Formulation or New Manufacturer Approval
08/08/2015 SYNAREL
NDA #019886		 SUPPL-32 NAFARELIN ACETATE PFIZER Labeling Approval
08/10/2015 ATROPEN
NDA #017106		 SUPPL-51 ATROPINE MMT Manufacturing (CMC) Approval
08/10/2015 MONISTAT 7
NDA #017450		 SUPPL-68 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
08/10/2015 CEREZYME
BLA #020367		 SUPPL-94 IMIGLUCERASE GENZYME Approval
08/10/2015 NICORETTE
NDA #021330		 SUPPL-20 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
08/10/2015 CAMPRAL
NDA #021431		 SUPPL-17 ACAMPROSATE CALCIUM FOREST LABS Manufacturing (CMC) Approval
08/10/2015 DORIBAX
NDA #022106		 SUPPL-15 DORIPENEM SHIONOGI INC Labeling Approval
08/10/2015 FIRAZYR
NDA #022150		 SUPPL-6 ICATIBANT ACETATE TAKEDA PHARMS USA Labeling Approval
08/10/2015 METOPROLOL TARTRATE
ANDA #074217		 SUPPL-26 METOPROLOL TARTRATE WATSON LABS Labeling Approval
08/10/2015 GLIPIZIDE
ANDA #074550		 SUPPL-10 GLIPIZIDE ACCORD HLTHCARE Labeling Approval
08/10/2015 CLONAZEPAM
ANDA #075468		 SUPPL-18 CLONAZEPAM RUBICON Labeling Approval
08/10/2015 CITALOPRAM HYDROBROMIDE
ANDA #077038		 SUPPL-11 CITALOPRAM HYDROBROMIDE DR REDDYS LABS LTD Labeling Approval
08/10/2015 CITALOPRAM HYDROBROMIDE
ANDA #077038		 SUPPL-14 CITALOPRAM HYDROBROMIDE DR REDDYS LABS LTD Labeling Approval
08/10/2015 ALPRAZOLAM
ANDA #077741		 SUPPL-2 ALPRAZOLAM APOTEX INC Labeling Approval
08/10/2015 ACETAMINOPHEN
ANDA #078569		 SUPPL-1 ACETAMINOPHEN SUN PHARM INDS LTD Labeling Approval
08/10/2015 ACETAMINOPHEN
ANDA #078569		 SUPPL-4 ACETAMINOPHEN SUN PHARM INDS LTD Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #090813		 SUPPL-1 LEVETIRACETAM FRESENIUS KABI USA Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #090813		 SUPPL-3 LEVETIRACETAM FRESENIUS KABI USA Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #090992		 SUPPL-1 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #090992		 SUPPL-3 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #090992		 SUPPL-4 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #091491		 SUPPL-3 LEVETIRACETAM ZHEJIANG JINGXIN Labeling Approval
08/10/2015 LEVETIRACETAM
ANDA #091491		 SUPPL-9 LEVETIRACETAM ZHEJIANG JINGXIN Labeling Approval
08/10/2015 MYRBETRIQ
NDA #202611		 SUPPL-6 MIRABEGRON APGDI Labeling Approval
08/10/2015 STRIBILD
NDA #203100		 SUPPL-17 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
08/10/2015 ZUBSOLV
NDA #204242		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE OREXO US INC Efficacy Approval
08/11/2015 DELESTROGEN
NDA #009402		 SUPPL-46 ESTRADIOL VALERATE ENDO OPERATIONS Manufacturing (CMC) Approval
08/11/2015 COPEGUS
NDA #021511		 SUPPL-29 RIBAVIRIN ROCHE Labeling Approval
08/11/2015 BROVANA
NDA #021912		 SUPPL-25 ARFORMOTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
08/11/2015 ONSOLIS
NDA #022266		 SUPPL-15 FENTANYL CITRATE ADALVO Manufacturing (CMC) Approval
08/11/2015 LAZANDA
NDA #022569		 SUPPL-16 FENTANYL CITRATE BTCP PHARMA Manufacturing (CMC) Approval
08/11/2015 HELIDAC
NDA #050719		 SUPPL-21 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE CASPER PHARMA LLC Labeling Approval
08/11/2015 BOTOX
BLA #103000		 SUPPL-5292 OnabotulinumtoxinA ALLERGAN Approval
08/11/2015 BOTOX COSMETIC
BLA #103000		 SUPPL-5292 OnabotulinumtoxinA ALLERGAN Approval
08/11/2015 ZELBORAF
NDA #202429		 SUPPL-8 VEMURAFENIB HOFFMANN LA ROCHE Labeling Approval
08/11/2015 TOLTERODINE TARTRATE
ANDA #203016		 ORIG-1 TOLTERODINE TARTRATE TORRENT Approval
08/11/2015 BREO ELLIPTA
NDA #204275		 SUPPL-5 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Manufacturing (CMC) Approval
08/11/2015 SIVEXTRO
NDA #205435		 SUPPL-2 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Manufacturing (CMC) Approval
08/12/2015 ACETAMINOPHEN
NDA #018337		 SUPPL-34 ACETAMINOPHEN TARO Labeling Approval
08/12/2015 INFANTS' FEVERALL
NDA #018337		 SUPPL-34 ACETAMINOPHEN TARO Labeling Approval
08/12/2015 SPRYCEL
NDA #021986		 SUPPL-16 DASATINIB BRISTOL MYERS SQUIBB Efficacy Approval
08/12/2015 SPRYCEL
NDA #021986		 SUPPL-17 DASATINIB BRISTOL MYERS SQUIBB Labeling Approval
08/12/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075817		 SUPPL-33 CIPROFLOXACIN HYDROCHLORIDE RISING Manufacturing (CMC) Approval
08/12/2015 CYTARABINE
ANDA #076512		 SUPPL-6 CYTARABINE FRESENIUS KABI USA Labeling Approval
08/12/2015 LEVOFLOXACIN
ANDA #078577		 ORIG-1 LEVOFLOXACIN HOSPIRA Approval
08/12/2015 SONAZINE
ANDA #080983		 SUPPL-59 CHLORPROMAZINE HYDROCHLORIDE FOSUN PHARMA Labeling Approval
08/12/2015 BEKYREE
ANDA #202226		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Approval
08/12/2015 ISIBLOOM
ANDA #202789		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL XIROMED Approval
08/12/2015 LOSARTAN POTASSIUM
ANDA #203835		 ORIG-1 LOSARTAN POTASSIUM HETERO LABS LTD V Approval
08/12/2015 ENVARSUS XR
NDA #206406		 SUPPL-1 TACROLIMUS VELOXIS PHARMS INC Labeling Approval
08/13/2015 AN-SULFUR COLLOID
NDA #017858		 SUPPL-42 TECHNETIUM TC-99M SULFUR COLLOID KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
08/13/2015 NOXAFIL
NDA #022003		 SUPPL-17 POSACONAZOLE SCHERING Manufacturing (CMC) Approval
08/13/2015 OXYCONTIN
NDA #022272		 SUPPL-27 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Efficacy Approval
08/13/2015 A-METHAPRED
ANDA #040664		 SUPPL-11 METHYLPREDNISOLONE SODIUM SUCCINATE HOSPIRA Labeling Approval
08/13/2015 A-METHAPRED
ANDA #040664		 SUPPL-12 METHYLPREDNISOLONE SODIUM SUCCINATE HOSPIRA Labeling Approval
08/13/2015 A-METHAPRED
ANDA #040665		 SUPPL-11 METHYLPREDNISOLONE SODIUM SUCCINATE HOSPIRA Labeling Approval
08/13/2015 A-METHAPRED
ANDA #040665		 SUPPL-12 METHYLPREDNISOLONE SODIUM SUCCINATE HOSPIRA Labeling Approval
08/13/2015 PENICILLIN G POTASSIUM
ANDA #065149		 SUPPL-4 PENICILLIN G POTASSIUM HQ SPECLT PHARMA Labeling Approval
08/13/2015 PACERONE
ANDA #075135		 SUPPL-45 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
08/13/2015 PACERONE
ANDA #075135		 SUPPL-46 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
08/13/2015 PACERONE
ANDA #075135		 SUPPL-47 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
08/13/2015 PACERONE
ANDA #075135		 SUPPL-48 AMIODARONE HYDROCHLORIDE UPSHER SMITH LABS Labeling Approval
08/13/2015 PROPAFENONE HYDROCHLORIDE
ANDA #075203		 SUPPL-12 PROPAFENONE HYDROCHLORIDE WATSON LABS Labeling Approval
08/13/2015 PROPAFENONE HYDROCHLORIDE
ANDA #075203		 SUPPL-15 PROPAFENONE HYDROCHLORIDE WATSON LABS Labeling Approval
08/13/2015 VALPROIC ACID
ANDA #075379		 SUPPL-7 VALPROIC ACID PHARM ASSOC Labeling Approval
08/13/2015 VALPROIC ACID
ANDA #075379		 SUPPL-9 VALPROIC ACID PHARM ASSOC Labeling Approval
08/13/2015 VALPROIC ACID
ANDA #075379		 SUPPL-10 VALPROIC ACID PHARM ASSOC Labeling Approval
08/13/2015 METOPROLOL TARTRATE
ANDA #077360		 SUPPL-10 METOPROLOL TARTRATE SANDOZ Labeling Approval
08/13/2015 METOPROLOL TARTRATE
ANDA #078085		 SUPPL-7 METOPROLOL TARTRATE HOSPIRA Labeling Approval
08/13/2015 SUMATRIPTAN SUCCINATE
ANDA #078327		 SUPPL-3 SUMATRIPTAN SUCCINATE AUROBINDO PHARMA Labeling Approval
08/13/2015 SUMATRIPTAN SUCCINATE
ANDA #078327		 SUPPL-6 SUMATRIPTAN SUCCINATE AUROBINDO PHARMA Labeling Approval
08/13/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078908		 SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
08/13/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078908		 SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
08/13/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078908		 SUPPL-7 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
08/13/2015 ANASTROZOLE
ANDA #078921		 SUPPL-3 ANASTROZOLE ZYDUS PHARMS USA INC Labeling Approval
08/13/2015 ANASTROZOLE
ANDA #078921		 SUPPL-4 ANASTROZOLE ZYDUS PHARMS USA INC Labeling Approval
08/13/2015 IBANDRONATE SODIUM
ANDA #078995		 SUPPL-1 IBANDRONATE SODIUM NORVIUM BIOSCIENCE Labeling Approval
08/13/2015 IBANDRONATE SODIUM
ANDA #078995		 SUPPL-3 IBANDRONATE SODIUM NORVIUM BIOSCIENCE Labeling Approval
08/13/2015 ANASTROZOLE
ANDA #079007		 SUPPL-2 ANASTROZOLE SANDOZ Labeling Approval
08/13/2015 ANASTROZOLE
ANDA #079007		 SUPPL-4 ANASTROZOLE SANDOZ Labeling Approval
08/13/2015 LAMIVUDINE AND ZIDOVUDINE
ANDA #079081		 SUPPL-2 LAMIVUDINE; ZIDOVUDINE CHARTWELL RX Labeling Approval
08/13/2015 CALCIPOTRIENE
ANDA #090633		 SUPPL-1 CALCIPOTRIENE GLENMARK PHARMS INC Manufacturing (CMC) Approval
08/13/2015 VALACYCLOVIR HYDROCHLORIDE
ANDA #090682		 SUPPL-7 VALACYCLOVIR HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/13/2015 FENOFIBRATE (MICRONIZED)
ANDA #090859		 SUPPL-2 FENOFIBRATE DR REDDYS LABS SA Labeling Approval
08/13/2015 LEVETIRACETAM
ANDA #090876		 ORIG-1 LEVETIRACETAM FRESENIUS KABI USA Approval
08/13/2015 METOPROLOL TARTRATE
ANDA #091045		 SUPPL-1 METOPROLOL TARTRATE FRESENIUS KABI USA Labeling Approval
08/13/2015 ANASTROZOLE
ANDA #091051		 SUPPL-2 ANASTROZOLE NORVIUM BIOSCIENCE Labeling Approval
08/13/2015 ANASTROZOLE
ANDA #091177		 SUPPL-2 ANASTROZOLE SUN PHARM INDS LTD Labeling Approval
08/13/2015 LEVETIRACETAM
ANDA #091338		 SUPPL-7 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
08/13/2015 LEVETIRACETAM
ANDA #091338		 SUPPL-8 LEVETIRACETAM TORRENT PHARMS LTD Labeling Approval
08/13/2015 LEVOFLOXACIN
ANDA #091644		 SUPPL-2 LEVOFLOXACIN RISING Labeling Approval
08/13/2015 LEVOFLOXACIN
ANDA #091644		 SUPPL-3 LEVOFLOXACIN RISING Labeling Approval
08/13/2015 NARATRIPTAN
ANDA #200502		 SUPPL-2 NARATRIPTAN HYDROCHLORIDE HERITAGE Labeling Approval
08/13/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201682		 SUPPL-1 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
08/13/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201682		 SUPPL-2 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
08/13/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #201682		 SUPPL-3 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
08/13/2015 XIMINO
NDA #201922		 SUPPL-2 MINOCYCLINE HYDROCHLORIDE JOURNEY Manufacturing (CMC) Approval
08/13/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202731		 SUPPL-4 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
08/13/2015 IMBRUVICA
NDA #205552		 SUPPL-3 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
08/13/2015 TRETINOIN
ANDA #207955		 ORIG-1 TRETINOIN MYLAN Approval
08/14/2015 METHOTREXATE LPF
NDA #011719		 SUPPL-121 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
08/14/2015 METHOTREXATE PRESERVATIVE FREE
NDA #011719		 SUPPL-121 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
08/14/2015 METHOTREXATE SODIUM
NDA #011719		 SUPPL-121 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
08/14/2015 METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719		 SUPPL-121 METHOTREXATE SODIUM HOSPIRA Manufacturing (CMC) Approval
08/14/2015 BREVIBLOC
NDA #019386		 SUPPL-48 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/14/2015 BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #019386		 SUPPL-48 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/14/2015 BREVIBLOC IN PLASTIC CONTAINER
NDA #019386		 SUPPL-48 ESMOLOL HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/14/2015 TIMOPTIC IN OCUDOSE
NDA #019463		 SUPPL-30 TIMOLOL MALEATE BAUSCH AND LOMB INC Manufacturing (CMC) Approval
08/14/2015 PHARMASEAL SCRUB CARE
NDA #019793		 SUPPL-5 CHLORHEXIDINE GLUCONATE CAREFUSION 2200 Manufacturing (CMC) Approval
08/14/2015 VENTOLIN HFA
NDA #020983		 SUPPL-34 ALBUTEROL SULFATE GLAXOSMITHKLINE Manufacturing (CMC) Approval
08/14/2015 DAYTRANA
NDA #021514		 SUPPL-23 METHYLPHENIDATE NOVEN PHARMS INC Labeling Approval
08/14/2015 KEPPRA
NDA #021872		 SUPPL-19 LEVETIRACETAM UCB INC Manufacturing (CMC) Approval
08/14/2015 NUEDEXTA
NDA #021879		 SUPPL-6 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE AVANIR PHARMS Manufacturing (CMC) Approval
08/14/2015 BYDUREON
NDA #022200		 SUPPL-11 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
08/14/2015 BYDUREON PEN
NDA #022200		 SUPPL-11 EXENATIDE SYNTHETIC ASTRAZENECA AB Manufacturing (CMC) Approval
08/14/2015 LIDOCAINE HYDROCHLORIDE
ANDA #091564		 ORIG-1 LIDOCAINE HYDROCHLORIDE AM REGENT Approval
08/14/2015 PROCYSBI
NDA #203389		 SUPPL-10 CYSTEAMINE BITARTRATE HORIZON Efficacy Approval
08/14/2015 ARIPIPRAZOLE
ANDA #203906		 ORIG-1 ARIPIPRAZOLE AMNEAL PHARMS Approval
08/14/2015 ARIPIPRAZOLE
ANDA #204171		 ORIG-1 ARIPIPRAZOLE LANNETT CO INC Approval
08/14/2015 AMMONIA N 13
ANDA #204547		 ORIG-1 AMMONIA N-13 PRECISION NUCLEAR Approval
08/14/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204602		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Approval
08/14/2015 ALEVE PM
NDA #205352		 SUPPL-5 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
08/17/2015 ANDROGEL
NDA #021015		 SUPPL-41 TESTOSTERONE BESINS HLTHCARE Manufacturing (CMC) Approval
08/17/2015 XYREM
NDA #021196		 SUPPL-22 SODIUM OXYBATE JAZZ PHARMS Manufacturing (CMC) Approval
08/17/2015 ANDROGEL
NDA #022309		 SUPPL-15 TESTOSTERONE BESINS HLTHCARE Manufacturing (CMC) Approval
08/17/2015 COLISTIMETHATE SODIUM
ANDA #065177		 SUPPL-12 COLISTIMETHATE SODIUM NEXUS Labeling Approval
08/17/2015 METHADONE HYDROCHLORIDE
ANDA #075082		 SUPPL-6 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
08/17/2015 ENALAPRIL MALEATE
ANDA #075459		 SUPPL-7 ENALAPRIL MALEATE SANDOZ INC Labeling Approval
08/17/2015 ENALAPRIL MALEATE
ANDA #075459		 SUPPL-8 ENALAPRIL MALEATE SANDOZ INC Manufacturing (CMC) Approval
08/17/2015 ENALAPRIL MALEATE
ANDA #075496		 SUPPL-7 ENALAPRIL MALEATE SANDOZ INC Labeling Approval
08/17/2015 ONDANSETRON HYDROCHLORIDE
ANDA #077172		 SUPPL-2 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
08/17/2015 ONDANSETRON HYDROCHLORIDE
ANDA #077172		 SUPPL-4 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
08/17/2015 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
ANDA #077270		 SUPPL-9 GLIPIZIDE; METFORMIN HYDROCHLORIDE TEVA PHARMS Labeling Approval
08/17/2015 GLIPIZIDE
ANDA #077820		 SUPPL-8 GLIPIZIDE SUN PHARM INDS INC Labeling Approval
08/17/2015 GLIPIZIDE
ANDA #077820		 SUPPL-9 GLIPIZIDE SUN PHARM INDS INC Labeling Approval
08/17/2015 YERVOY
BLA #125377		 SUPPL-74 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
08/17/2015 ADCETRIS
BLA #125388		 SUPPL-80 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
08/17/2015 ADCETRIS
BLA #125388		 SUPPL-81 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
08/17/2015 OXYCODONE HYDROCHLORIDE
ANDA #202773		 ORIG-1 OXYCODONE HYDROCHLORIDE AVANTHI INC Approval
08/17/2015 FENOFIBRATE
ANDA #204019		 ORIG-1 FENOFIBRATE LUPIN LTD Approval
08/17/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #204296		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Approval
08/17/2015 IMBRUVICA
NDA #205552		 SUPPL-4 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
08/17/2015 TETRABENAZINE
ANDA #206129		 ORIG-1 TETRABENAZINE SUN PHARM Approval
08/18/2015 EFUDEX
NDA #016831		 SUPPL-58 FLUOROURACIL EXTROVIS Manufacturing (CMC) Approval
08/18/2015 KINEVAC
NDA #017697		 SUPPL-26 SINCALIDE BRACCO Manufacturing (CMC) Approval
08/18/2015 HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609		 SUPPL-49 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
08/18/2015 HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609		 SUPPL-49 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
08/18/2015 HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609		 SUPPL-49 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
08/18/2015 PULMICORT RESPULES
NDA #020929		 SUPPL-51 BUDESONIDE ASTRAZENECA Manufacturing (CMC) Approval
08/18/2015 DEFINITY
NDA #021064		 SUPPL-17 PERFLUTREN LANTHEUS MEDCL Labeling Approval
08/18/2015 DEFINITY RT
NDA #021064		 SUPPL-17 PERFLUTREN LANTHEUS MEDCL Labeling Approval
08/18/2015 ZEMPLAR
NDA #021606		 SUPPL-15 PARICALCITOL ABBVIE Manufacturing (CMC) Approval
08/18/2015 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434		 SUPPL-8 ARGATROBAN CIPLA Manufacturing (CMC) Approval
08/18/2015 ADDYI
NDA #022526		 ORIG-1 FLIBANSERIN SPROUT PHARMS Type 1 - New Molecular Entity Approval
08/18/2015 PENICILLIN G SODIUM
ANDA #065068		 SUPPL-14 PENICILLIN G SODIUM SANDOZ Labeling Approval
08/18/2015 DEMECLOCYCLINE HYDROCHLORIDE
ANDA #065447		 ORIG-1 DEMECLOCYCLINE HYDROCHLORIDE EPIC PHARMA LLC Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070583		 SUPPL-27 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070584		 SUPPL-27 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070585		 SUPPL-28 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070586		 SUPPL-18 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070590		 SUPPL-24 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070597		 SUPPL-25 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #070609		 SUPPL-21 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/18/2015 MINOXIDIL (FOR MEN)
ANDA #074731		 SUPPL-2 MINOXIDIL HIKMA Labeling Approval
08/18/2015 MINOXIDIL (FOR WOMEN)
ANDA #074731		 SUPPL-2 MINOXIDIL HIKMA Labeling Approval
08/18/2015 OXANDROLONE
ANDA #076761		 SUPPL-7 OXANDROLONE UPSHER SMITH LABS Labeling Approval
08/18/2015 NATEGLINIDE
ANDA #077461		 SUPPL-1 NATEGLINIDE DR REDDYS LABS LTD Labeling Approval
08/18/2015 MOMETASONE FUROATE
ANDA #078571		 SUPPL-7 MOMETASONE FUROATE GLENMARK PHARMS INC Labeling Approval
08/18/2015 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-11 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
08/18/2015 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-12 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
08/18/2015 DIVALPROEX SODIUM
ANDA #078979		 SUPPL-14 DIVALPROEX SODIUM DR REDDYS LABS LTD Labeling Approval
08/18/2015 LARYNG-O-JET KIT
ANDA #086364		 SUPPL-35 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Labeling Approval
08/18/2015 METHADONE HYDROCHLORIDE
ANDA #090065		 ORIG-1 METHADONE HYDROCHLORIDE EPIC PHARMA LLC Approval
08/18/2015 MOMETASONE FUROATE
ANDA #090506		 SUPPL-2 MOMETASONE FUROATE GLENMARK PHARMS LTD Labeling Approval
08/18/2015 EPINASTINE HYDROCHLORIDE
ANDA #090951		 SUPPL-3 EPINASTINE HYDROCHLORIDE SOMERSET THERAPS LLC Labeling Approval
08/18/2015 ACTEMRA
BLA #125276		 SUPPL-106 TOCILIZUMAB GENENTECH Approval
08/18/2015 ACTEMRA
BLA #125472		 SUPPL-14 TOCILIZUMAB GENENTECH Approval
08/18/2015 ZYTIGA
NDA #202379		 SUPPL-20 ABIRATERONE ACETATE JANSSEN BIOTECH Manufacturing (CMC) Approval
08/18/2015 SODIUM FLUORIDE F-18
ANDA #203592		 ORIG-1 SODIUM FLUORIDE F-18 SOFIE Approval
08/18/2015 CISPLATIN
ANDA #206774		 ORIG-1 CISPLATIN ACCORD HLTHCARE Approval
08/19/2015 OXISTAT
NDA #020209		 SUPPL-10 OXICONAZOLE NITRATE ANI PHARMS Manufacturing (CMC) Approval
08/19/2015 IMPLANON
NDA #021529		 SUPPL-11 ETONOGESTREL ORGANON Labeling Approval
08/19/2015 NEXPLANON
NDA #021529		 SUPPL-11 ETONOGESTREL ORGANON Labeling Approval
08/19/2015 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #090704		 SUPPL-2 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE MYLAN Labeling Approval
08/19/2015 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #090704		 SUPPL-4 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE MYLAN Labeling Approval
08/19/2015 RAMELTEON
ANDA #091610		 ORIG-1 RAMELTEON ACTAVIS LABS FL INC Approval
08/19/2015 NORTHERA
NDA #203202		 SUPPL-4 DROXIDOPA LUNDBECK NA LTD Manufacturing (CMC) Approval
08/19/2015 OMEPRAZOLE
ANDA #203270		 ORIG-1 OMEPRAZOLE AUROBINDO PHARMA Approval
08/19/2015 SOVALDI
NDA #204671		 SUPPL-2 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
08/19/2015 IBANDRONATE SODIUM
ANDA #205332		 ORIG-1 IBANDRONATE SODIUM EUGIA PHARMA Approval
08/19/2015 POKONZA
NDA #208019		 ORIG-1 POTASSIUM CHLORIDE GENUS Type 7 - Drug Already Marketed without Approved NDA Approval
08/19/2015 POTASSIUM CHLORIDE
NDA #208019		 ORIG-1 POTASSIUM CHLORIDE GENUS Type 7 - Drug Already Marketed without Approved NDA Approval
08/20/2015 GEODON
NDA #020825		 SUPPL-54 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
08/20/2015 GEODON
NDA #020919		 SUPPL-41 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
08/20/2015 GEODON
NDA #021483		 SUPPL-14 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Approval
08/20/2015 VELCADE
NDA #021602		 SUPPL-41 BORTEZOMIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/20/2015 VERDESO
NDA #021978		 SUPPL-11 DESONIDE ALMIRALL Manufacturing (CMC) Approval
08/20/2015 BLEOMYCIN SULFATE
ANDA #065031		 SUPPL-14 BLEOMYCIN SULFATE HOSPIRA Labeling Approval
08/20/2015 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071165		 SUPPL-28 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
08/20/2015 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071165		 SUPPL-30 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
08/20/2015 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071167		 SUPPL-29 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
08/20/2015 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071167		 SUPPL-31 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
08/20/2015 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071170		 SUPPL-29 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
08/20/2015 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #071170		 SUPPL-31 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE HOSPIRA Labeling Approval
08/20/2015 METFORMIN HYDROCHLORIDE
ANDA #075984		 SUPPL-20 METFORMIN HYDROCHLORIDE APOTEX Labeling Approval
08/20/2015 TERCONAZOLE
ANDA #076043		 SUPPL-8 TERCONAZOLE TARO Labeling Approval
08/20/2015 TERCONAZOLE
ANDA #076043		 SUPPL-9 TERCONAZOLE TARO Labeling Approval
08/20/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #077302		 SUPPL-16 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ACTAVIS ELIZABETH Labeling Approval
08/20/2015 METOPROLOL TARTRATE
ANDA #078459		 SUPPL-10 METOPROLOL TARTRATE IPCA LABS LTD Labeling Approval
08/20/2015 OLANZAPINE
ANDA #202050		 SUPPL-8 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
08/20/2015 TRANEXAMIC ACID
ANDA #202093		 SUPPL-1 TRANEXAMIC ACID ACTAVIS LABS FL INC Labeling Approval
08/20/2015 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202126		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE GLAND Approval
08/20/2015 DICLOFENAC SODIUM
ANDA #204132		 ORIG-1 DICLOFENAC SODIUM LUPIN LTD Approval
08/20/2015 ACYCLOVIR
ANDA #204605		 SUPPL-1 ACYCLOVIR AMNEAL PHARMS Manufacturing (CMC) Approval
08/21/2015 NAVELBINE
NDA #020388		 SUPPL-31 VINORELBINE TARTRATE PIERRE FABRE Manufacturing (CMC) Approval
08/21/2015 NATAZIA
NDA #022252		 SUPPL-4 DIENOGEST; ESTRADIOL VALERATE BAYER HLTHCARE Labeling Approval
08/21/2015 OMEPRAZOLE
ANDA #075785		 SUPPL-5 OMEPRAZOLE IMPAX LABS Labeling Approval
08/21/2015 OMEPRAZOLE
ANDA #075785		 SUPPL-6 OMEPRAZOLE IMPAX LABS Labeling Approval
08/21/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-10 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
08/21/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
08/21/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090528		 SUPPL-13 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TORRENT PHARMS Labeling Approval
08/21/2015 MESNA
ANDA #090913		 SUPPL-4 MESNA SAGENT PHARMS INC Labeling Approval
08/21/2015 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-6 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
08/21/2015 MIRCERA
BLA #125164		 SUPPL-70 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA HOFFMAN-LA ROCHE Approval
08/21/2015 ZOLEDRONIC ACID
ANDA #202828		 SUPPL-7 ZOLEDRONIC ACID INFORLIFE Labeling Approval
08/21/2015 CELECOXIB
ANDA #204519		 ORIG-1 CELECOXIB ALEMBIC Approval
08/21/2015 ENTECAVIR
ANDA #205740		 ORIG-1 ENTECAVIR HETERO LABS LTD V Approval
08/24/2015 METHADONE HYDROCHLORIDE
NDA #017058		 SUPPL-20 METHADONE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
08/24/2015 LOVENOX
NDA #020164		 SUPPL-107 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
08/24/2015 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-107 ENOXAPARIN SODIUM SANOFI AVENTIS US Manufacturing (CMC) Approval
08/24/2015 NAPROXEN
ANDA #074190		 SUPPL-11 NAPROXEN HIKMA Labeling Approval
08/24/2015 DICLOFENAC SODIUM
ANDA #075185		 SUPPL-11 DICLOFENAC SODIUM CARLSBAD Labeling Approval
08/24/2015 TIZANIDINE HYDROCHLORIDE
ANDA #076286		 SUPPL-11 TIZANIDINE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
08/24/2015 TIZANIDINE HYDROCHLORIDE
ANDA #076286		 SUPPL-12 TIZANIDINE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
08/24/2015 DEXTROAMPHETAMINE SULFATE
ANDA #076353		 SUPPL-10 DEXTROAMPHETAMINE SULFATE SPECGX LLC Labeling Approval
08/24/2015 HYDROXYPROGESTERONE CAPROATE
ANDA #200271		 ORIG-1 HYDROXYPROGESTERONE CAPROATE ASPEN GLOBAL INC Approval
08/24/2015 OPANA ER
NDA #201655		 SUPPL-18 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Manufacturing (CMC) Approval
08/24/2015 ZECUITY
NDA #202278		 SUPPL-6 SUMATRIPTAN SUCCINATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/24/2015 PROPAFENONE HYDROCHLORIDE
ANDA #202688		 ORIG-1 PROPAFENONE HYDROCHLORIDE WATSON LABS INC Approval
08/24/2015 NORTHERA
NDA #203202		 SUPPL-5 DROXIDOPA LUNDBECK NA LTD Manufacturing (CMC) Approval
08/24/2015 ICLUSIG
NDA #203469		 SUPPL-18 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
08/24/2015 OSPHENA
NDA #203505		 SUPPL-8 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
08/24/2015 OSPHENA
NDA #203505		 SUPPL-9 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
08/24/2015 OSPHENA
NDA #203505		 SUPPL-10 OSPEMIFENE DUCHESNAY Manufacturing (CMC) Approval
08/24/2015 AFINITOR DISPERZ
NDA #203985		 SUPPL-9 EVEROLIMUS NOVARTIS PHARM Manufacturing (CMC) Approval
08/24/2015 OXYCODONE HYDROCHLORIDE
ANDA #204752		 ORIG-1 OXYCODONE HYDROCHLORIDE NOVEL LABS INC Approval
08/24/2015 IMBRUVICA
NDA #205552		 SUPPL-5 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
08/24/2015 RASUVO
NDA #205776		 SUPPL-1 METHOTREXATE MEDEXUS Labeling Approval
08/24/2015 SAVAYSA
NDA #206316		 SUPPL-1 EDOXABAN TOSYLATE DAIICHI SANKYO INC Manufacturing (CMC) Approval
08/24/2015 PROMACTA KIT
NDA #207027		 ORIG-1 ELTROMBOPAG OLAMINE NOVARTIS Type 3 - New Dosage Form and Type 4 - New Combination Approval
08/25/2015 VASOTEC
NDA #018998		 SUPPL-80 ENALAPRIL MALEATE BAUSCH Labeling Approval
08/25/2015 VASERETIC
NDA #019221		 SUPPL-45 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE BAUSCH Labeling Approval
08/25/2015 ZESTRIL
NDA #019777		 SUPPL-73 LISINOPRIL TWI PHARMS Labeling Approval
08/25/2015 ZESTORETIC
NDA #019888		 SUPPL-65 HYDROCHLOROTHIAZIDE; LISINOPRIL ALMATICA Labeling Approval
08/25/2015 LOTENSIN HCT
NDA #020033		 SUPPL-52 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Labeling Approval
08/25/2015 XENAZINE
NDA #021894		 SUPPL-12 TETRABENAZINE BAUSCH REMS Approval
08/25/2015 BUPIVACAINE HYDROCHLORIDE
ANDA #071810		 SUPPL-17 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/25/2015 DILTIAZEM HYDROCHLORIDE
ANDA #074943		 SUPPL-14 DILTIAZEM HYDROCHLORIDE APOTEX Labeling Approval
08/25/2015 LISINOPRIL
ANDA #075944		 SUPPL-24 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/25/2015 LISINOPRIL
ANDA #075944		 SUPPL-25 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/25/2015 LISINOPRIL
ANDA #075944		 SUPPL-26 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
08/25/2015 TERCONAZOLE
ANDA #075953		 SUPPL-11 TERCONAZOLE TARO Labeling Approval
08/25/2015 TERCONAZOLE
ANDA #075953		 SUPPL-12 TERCONAZOLE TARO Labeling Approval
08/25/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #077488		 SUPPL-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA Labeling Approval
08/25/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #077488		 SUPPL-2 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA Labeling Approval
08/25/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #077488		 SUPPL-3 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA Labeling Approval
08/25/2015 SOTALOL HYDROCHLORIDE
ANDA #077616		 SUPPL-4 SOTALOL HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
08/25/2015 LISINOPRIL
ANDA #077622		 SUPPL-19 LISINOPRIL AUROBINDO Labeling Approval
08/25/2015 LISINOPRIL
ANDA #077622		 SUPPL-20 LISINOPRIL AUROBINDO Labeling Approval
08/25/2015 LISINOPRIL
ANDA #077622		 SUPPL-21 LISINOPRIL AUROBINDO Labeling Approval
08/25/2015 TERBINAFINE HYDROCHLORIDE
ANDA #078199		 SUPPL-8 TERBINAFINE HYDROCHLORIDE CHARTWELL Labeling Approval
08/25/2015 TERBINAFINE HYDROCHLORIDE
ANDA #078297		 SUPPL-12 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/25/2015 TERBINAFINE HYDROCHLORIDE
ANDA #078297		 SUPPL-13 TERBINAFINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
08/25/2015 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-5 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
08/25/2015 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-6 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
08/25/2015 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-7 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
08/25/2015 ATOMOXETINE HYDROCHLORIDE
ANDA #079017		 SUPPL-5 ATOMOXETINE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
08/25/2015 ATOMOXETINE HYDROCHLORIDE
ANDA #079017		 SUPPL-6 ATOMOXETINE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
08/25/2015 QUETIAPINE FUMARATE
ANDA #090120		 SUPPL-2 QUETIAPINE FUMARATE HIKMA Labeling Approval
08/25/2015 QUETIAPINE FUMARATE
ANDA #090120		 SUPPL-4 QUETIAPINE FUMARATE HIKMA Labeling Approval
08/25/2015 TRI-ESTARYLLA
ANDA #090793		 SUPPL-3 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Labeling Approval
08/25/2015 TRI-ESTARYLLA
ANDA #090793		 SUPPL-4 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Labeling Approval
08/25/2015 QUETIAPINE FUMARATE
ANDA #090960		 SUPPL-3 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
08/25/2015 QUETIAPINE FUMARATE
ANDA #090960		 SUPPL-5 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
08/25/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #090964		 SUPPL-2 OXYMORPHONE HYDROCHLORIDE HIKMA Labeling Approval
08/25/2015 TESTOSTERONE CYPIONATE
ANDA #201720		 SUPPL-6 TESTOSTERONE CYPIONATE SUN PHARM INDS LTD Labeling Approval
08/25/2015 OMEPRAZOLE
ANDA #202384		 ORIG-1 OMEPRAZOLE LUPIN LTD Approval
08/25/2015 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #203263		 SUPPL-5 DOXORUBICIN HYDROCHLORIDE SUN PHARM Labeling Approval
08/25/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204266		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC Approval
08/25/2015 PRESTALIA
NDA #205003		 SUPPL-1 AMLODIPINE BESYLATE; PERINDOPRIL ARGININE ADHERA Labeling Approval
08/25/2015 ZYKADIA
NDA #205755		 SUPPL-5 CERITINIB NOVARTIS Manufacturing (CMC) Approval
08/26/2015 PRADAXA
NDA #022512		 SUPPL-31 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
08/26/2015 CEFTIN
NDA #050605		 SUPPL-48 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
08/26/2015 CEFTIN
NDA #050672		 SUPPL-34 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
08/26/2015 MINOCYCLINE HYDROCHLORIDE
ANDA #090422		 SUPPL-11 MINOCYCLINE HYDROCHLORIDE SANDOZ Labeling Approval
08/26/2015 PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
ANDA #200963		 ORIG-1 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE AMNEAL PHARMS Approval
08/26/2015 EDURANT
NDA #202022		 SUPPL-8 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Efficacy Approval
08/26/2015 DULOXETINE HYDROCHLORIDE
ANDA #203197		 ORIG-1 DULOXETINE HYDROCHLORIDE ALKEM LABS LTD Approval
08/26/2015 NYMALIZE
NDA #203340		 SUPPL-3 NIMODIPINE AZURITY Manufacturing (CMC) Approval
08/26/2015 JUBLIA
NDA #203567		 SUPPL-3 EFINACONAZOLE BAUSCH Manufacturing (CMC) Approval
08/26/2015 DEXTROAMPHETAMINE SULFATE
ANDA #203901		 SUPPL-8 DEXTROAMPHETAMINE SULFATE ACTAVIS ELIZABETH Labeling Approval
08/26/2015 SYNJARDY
NDA #206111		 ORIG-1 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Type 4 - New Combination Approval
08/26/2015 ENTECAVIR
ANDA #206217		 ORIG-1 ENTECAVIR AUROBINDO PHARMA Approval
08/27/2015 TECHNELITE
NDA #017771		 SUPPL-39 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR LANTHEUS MEDCL Manufacturing (CMC) Approval
08/27/2015 RIMSO-50
NDA #017788		 SUPPL-23 DIMETHYL SULFOXIDE MYLAN INSTITUTIONAL Manufacturing (CMC) Approval
08/27/2015 TENORMIN
NDA #018240		 SUPPL-37 ATENOLOL TWI PHARMS Manufacturing (CMC) Approval
08/27/2015 LUNESTA
NDA #021476		 SUPPL-32 ESZOPICLONE WAYLIS THERAP Manufacturing (CMC) Approval
08/27/2015 MYCAMINE
NDA #021506		 SUPPL-16 MICAFUNGIN SODIUM ASTELLAS Manufacturing (CMC) Approval
08/27/2015 APTIOM
NDA #022416		 SUPPL-1 ESLICARBAZEPINE ACETATE SUMITOMO PHARMA AM Efficacy Approval
08/27/2015 SUCRALFATE
ANDA #070848		 SUPPL-35 SUCRALFATE TEVA Labeling Approval
08/27/2015 PROPAFENONE HYDROCHLORIDE
ANDA #075938		 SUPPL-11 PROPAFENONE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
08/27/2015 MIRTAZAPINE
ANDA #076122		 SUPPL-21 MIRTAZAPINE MYLAN Labeling Approval
08/27/2015 FLUCONAZOLE
ANDA #076918		 SUPPL-4 FLUCONAZOLE TARO PHARM INDS Labeling Approval
08/27/2015 FLUCONAZOLE
ANDA #076918		 SUPPL-5 FLUCONAZOLE TARO PHARM INDS Labeling Approval
08/27/2015 FLUCONAZOLE
ANDA #076918		 SUPPL-6 FLUCONAZOLE TARO PHARM INDS Labeling Approval
08/27/2015 VIVACAINE
ANDA #077250		 SUPPL-10 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE SEPTODONT Labeling Approval
08/27/2015 MELPHALAN HYDROCHLORIDE
ANDA #090270		 SUPPL-7 MELPHALAN HYDROCHLORIDE MYLAN INSTITUTIONAL Labeling Approval
08/27/2015 REMICADE
BLA #103772		 SUPPL-5374 INFLIXIMAB CENTOCOR INC Approval
08/27/2015 ACTIMMUNE
BLA #103836		 SUPPL-5182 INTERFERON GAMMA-1B HORIZON THERAPEUTICS IRELAND DAC Approval
08/27/2015 MYALEPT
BLA #125390		 SUPPL-6 METRELEPTIN AMRYT Approval
08/27/2015 REPATHA
BLA #125522		 ORIG-1 EVOLOCUMAB AMGEN INC Approval
08/27/2015 RISPERIDONE
ANDA #201003		 SUPPL-3 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
08/27/2015 RISPERIDONE
ANDA #201003		 SUPPL-4 RISPERIDONE AJANTA PHARMA LTD Labeling Approval
08/27/2015 ANORO ELLIPTA
NDA #203975		 SUPPL-2 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Manufacturing (CMC) Approval
08/27/2015 AURYXIA
NDA #205874		 SUPPL-7 FERRIC CITRATE KERYX BIOPHARMS Manufacturing (CMC) Approval
08/28/2015 TEGRETOL
NDA #016608		 SUPPL-97 CARBAMAZEPINE NOVARTIS Labeling Approval
08/28/2015 TEGRETOL
NDA #018281		 SUPPL-45 CARBAMAZEPINE NOVARTIS Labeling Approval
08/28/2015 TEGRETOL
NDA #018927		 SUPPL-38 CARBAMAZEPINE NOVARTIS Labeling Approval
08/28/2015 PRINIVIL
NDA #019558		 SUPPL-59 LISINOPRIL MERCK Labeling Approval
08/28/2015 TEGRETOL-XR
NDA #020234		 SUPPL-26 CARBAMAZEPINE NOVARTIS Labeling Approval
08/28/2015 ARAVA
NDA #020905		 SUPPL-27 LEFLUNOMIDE SANOFI AVENTIS US Labeling Approval
08/28/2015 EMEND
NDA #021549		 SUPPL-25 APREPITANT MERCK Efficacy Approval
08/28/2015 JANUVIA
NDA #021995		 SUPPL-34 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
08/28/2015 JANUMET
NDA #022044		 SUPPL-35 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
08/28/2015 NESINA
NDA #022271		 SUPPL-7 ALOGLIPTIN BENZOATE TAKEDA PHARMS USA Labeling Approval
08/28/2015 ONGLYZA
NDA #022350		 SUPPL-16 SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
08/28/2015 OSENI
NDA #022426		 SUPPL-5 ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
08/28/2015 ESCITALOPRAM OXALATE
ANDA #078032		 ORIG-1 ESCITALOPRAM OXALATE PRINSTON INC Approval
08/28/2015 CHLOROQUINE PHOSPHATE
ANDA #090249		 SUPPL-2 CHLOROQUINE PHOSPHATE IPCA LABS LTD Labeling Approval
08/28/2015 ERLOTINIB HYDROCHLORIDE
ANDA #091059		 ORIG-1 ERLOTINIB HYDROCHLORIDE TEVA PHARMS USA INC Approval
08/28/2015 KOMBIGLYZE XR
NDA #200678		 SUPPL-16 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
08/28/2015 TRADJENTA
NDA #201280		 SUPPL-12 LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
08/28/2015 JENTADUETO
NDA #201281		 SUPPL-10 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
08/28/2015 JANUMET XR
NDA #202270		 SUPPL-10 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
08/28/2015 KAZANO
NDA #203414		 SUPPL-5 ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
08/28/2015 RALOXIFENE HYDROCHLORIDE
ANDA #204310		 ORIG-1 RALOXIFENE HYDROCHLORIDE AUROBINDO PHARMA Approval
08/28/2015 GLYXAMBI
NDA #206073		 SUPPL-1 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
08/31/2015 PREMPHASE 14/14
NDA #020527		 SUPPL-62 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE WYETH PHARMS Labeling Approval
08/31/2015 PREMPRO
NDA #020527		 SUPPL-62 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE WYETH PHARMS Labeling Approval
08/31/2015 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-12 FENOFIBRATE LUPIN Manufacturing (CMC) Approval
08/31/2015 NOREPINEPHRINE BITARTRATE
ANDA #040455		 SUPPL-18 NOREPINEPHRINE BITARTRATE MEITHEAL Manufacturing (CMC) Approval
08/31/2015 VINCRISTINE SULFATE PFS
ANDA #075493		 SUPPL-23 VINCRISTINE SULFATE TEVA PHARMS USA Labeling Approval
08/31/2015 VINCRISTINE SULFATE PFS
ANDA #075493		 SUPPL-29 VINCRISTINE SULFATE TEVA PHARMS USA Labeling Approval
08/31/2015 VINCRISTINE SULFATE PFS
ANDA #075493		 SUPPL-38 VINCRISTINE SULFATE TEVA PHARMS USA Labeling Approval
08/31/2015 KETOCONAZOLE
ANDA #076419		 SUPPL-15 KETOCONAZOLE PADAGIS ISRAEL Labeling Approval
08/31/2015 DANTROLENE SODIUM
ANDA #076856		 SUPPL-8 DANTROLENE SODIUM IMPAX LABS Labeling Approval
08/31/2015 ALCLOMETASONE DIPROPIONATE
ANDA #076884		 SUPPL-4 ALCLOMETASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
08/31/2015 KETOCONAZOLE
ANDA #076942		 SUPPL-20 KETOCONAZOLE COSETTE Labeling Approval
08/31/2015 ALCLOMETASONE DIPROPIONATE
ANDA #076973		 SUPPL-3 ALCLOMETASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
08/31/2015 TRANDOLAPRIL
ANDA #077489		 SUPPL-6 TRANDOLAPRIL TEVA PHARMS Labeling Approval
08/31/2015 TRANDOLAPRIL
ANDA #077489		 SUPPL-7 TRANDOLAPRIL TEVA PHARMS Labeling Approval
08/31/2015 TRANDOLAPRIL
ANDA #077489		 SUPPL-8 TRANDOLAPRIL TEVA PHARMS Labeling Approval
08/31/2015 TRANDOLAPRIL
ANDA #077489		 SUPPL-10 TRANDOLAPRIL TEVA PHARMS Labeling Approval
08/31/2015 RAMIPRIL
ANDA #077626		 SUPPL-17 RAMIPRIL LUPIN Manufacturing (CMC) Approval
08/31/2015 GALANTAMINE HYDROBROMIDE
ANDA #090178		 SUPPL-5 GALANTAMINE HYDROBROMIDE SUN PHARM Labeling Approval
08/31/2015 GALANTAMINE HYDROBROMIDE
ANDA #090178		 SUPPL-6 GALANTAMINE HYDROBROMIDE SUN PHARM Labeling Approval
08/31/2015 ESTARYLLA
ANDA #090794		 SUPPL-2 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Labeling Approval
08/31/2015 ESTARYLLA
ANDA #090794		 SUPPL-4 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Labeling Approval
08/31/2015 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-9 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Manufacturing (CMC) Approval
08/31/2015 ESCITALOPRAM OXALATE
ANDA #090939		 SUPPL-10 ESCITALOPRAM OXALATE TORRENT PHARMS LTD Labeling Approval
08/31/2015 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #091070		 ORIG-1 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN ACTAVIS LABS FL Approval
08/31/2015 TEFLARO
NDA #200327		 SUPPL-13 CEFTAROLINE FOSAMIL ABBVIE Efficacy Approval
08/31/2015 TEFLARO
NDA #200327		 SUPPL-14 CEFTAROLINE FOSAMIL ABBVIE Efficacy Approval
08/31/2015 TEFLARO
NDA #200327		 SUPPL-15 CEFTAROLINE FOSAMIL ABBVIE Labeling Approval
08/31/2015 ZOLEDRONIC ACID
NDA #203231		 SUPPL-8 ZOLEDRONIC ACID INFORLIFE Manufacturing (CMC) Approval
08/31/2015 ZOLEDRONIC ACID
NDA #203231		 SUPPL-9 ZOLEDRONIC ACID INFORLIFE Manufacturing (CMC) Approval
08/31/2015 TOLTERODINE TARTRATE
ANDA #203409		 ORIG-1 TOLTERODINE TARTRATE MACLEODS PHARMS LTD Approval
08/31/2015 METHADONE HYDROCHLORIDE
ANDA #203502		 ORIG-1 METHADONE HYDROCHLORIDE AUROLIFE PHARMA LLC Approval
08/31/2015 FLUDEOXYGLUCOSE F18
ANDA #203591		 ORIG-1 FLUDEOXYGLUCOSE F-18 SOFIE Approval
08/31/2015 FLUDEOXYGLUCOSE F18
ANDA #203771		 ORIG-1 FLUDEOXYGLUCOSE F-18 QUEEN HAMAMATSU PET Approval
08/31/2015 RIVASTIGMINE
ANDA #204403		 ORIG-1 RIVASTIGMINE ALVOGEN Approval
08/31/2015 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE NATCO Approval
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