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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 2018

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 May 03, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/01/2018 JYNARQUE
NDA #204441		 SUPPL-2 TOLVAPTAN OTSUKA REMS Approval
12/02/2018 PROGRAF
NDA #050708		 SUPPL-48 TACROLIMUS ASTELLAS Labeling Approval
12/02/2018 PROGRAF
NDA #050709		 SUPPL-41 TACROLIMUS ASTELLAS Labeling Approval
12/02/2018 PROGRAF
NDA #210115		 SUPPL-1 TACROLIMUS ASTELLAS Labeling Approval
12/03/2018 ZYLOPRIM
NDA #016084		 SUPPL-44 ALLOPURINOL CASPER PHARMA LLC Labeling Approval
12/03/2018 CUBICIN
NDA #021572		 SUPPL-61 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
12/03/2018 CUBICIN RF
NDA #021572		 SUPPL-61 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
12/03/2018 VIBRAMYCIN
NDA #050006		 SUPPL-91 DOXYCYCLINE PFIZER Labeling Approval
12/03/2018 VIBRAMYCIN
NDA #050007		 SUPPL-33 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
12/03/2018 VIBRAMYCIN
NDA #050480		 SUPPL-57 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
12/03/2018 VIBRA-TABS
NDA #050533		 SUPPL-46 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
12/03/2018 DILANTIN
ANDA #084349		 SUPPL-85 PHENYTOIN SODIUM VIATRIS Labeling Approval
12/03/2018 DILANTIN
ANDA #084427		 SUPPL-42 PHENYTOIN PHARMACIA Labeling Approval
12/03/2018 NATEGLINIDE
ANDA #205055		 SUPPL-1 NATEGLINIDE ALVOGEN Labeling Approval
12/03/2018 SILODOSIN
ANDA #206541		 ORIG-1 SILODOSIN LUPIN LTD Approval
12/03/2018 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #209010		 ORIG-1 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL SCIEGEN PHARMS INC Approval
12/03/2018 SILODOSIN
ANDA #209745		 ORIG-1 SILODOSIN AMNEAL PHARMS CO Approval
12/03/2018 SILODOSIN
ANDA #210687		 ORIG-1 SILODOSIN MSN Approval
12/03/2018 FLUOXETINE HYDROCHLORIDE
ANDA #211051		 ORIG-1 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Approval
12/03/2018 SILODOSIN
ANDA #211060		 ORIG-1 SILODOSIN AJANTA PHARMA LTD Approval
12/03/2018 SILODOSIN
ANDA #211166		 ORIG-1 SILODOSIN MACLEODS PHARMS LTD Approval
12/04/2018 NUVARING
NDA #021187		 SUPPL-35 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Labeling Approval
12/04/2018 NUVARING
NDA #021187		 SUPPL-36 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Labeling Approval
12/04/2018 RABEPRAZOLE SODIUM
ANDA #076822		 SUPPL-5 RABEPRAZOLE SODIUM TEVA PHARMS USA Labeling Approval
12/04/2018 RABEPRAZOLE SODIUM
ANDA #076822		 SUPPL-6 RABEPRAZOLE SODIUM TEVA PHARMS USA Labeling Approval
12/04/2018 RABEPRAZOLE SODIUM
ANDA #076822		 SUPPL-8 RABEPRAZOLE SODIUM TEVA PHARMS USA Labeling Approval
12/04/2018 RABEPRAZOLE SODIUM
ANDA #076822		 SUPPL-10 RABEPRAZOLE SODIUM TEVA PHARMS USA Labeling Approval
12/04/2018 EMTRICITABINE
ANDA #204396		 ORIG-1 EMTRICITABINE MICRO LABS Tentative Approval
12/04/2018 SAXENDA
NDA #206321		 SUPPL-9 LIRAGLUTIDE NOVO REMS Approval
12/04/2018 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #207676		 ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS SA Approval
12/04/2018 TOREMIFENE CITRATE
ANDA #208813		 ORIG-1 TOREMIFENE CITRATE RISING Approval
12/04/2018 CANDESARTAN CILEXETIL
ANDA #210302		 ORIG-1 CANDESARTAN CILEXETIL ALEMBIC Approval
12/04/2018 PREDNISONE
ANDA #210525		 ORIG-1 PREDNISONE GENEYORK PHARMS Approval
12/05/2018 GLIADEL
NDA #020637		 SUPPL-29 CARMUSTINE AZURITY Labeling Approval
12/06/2018 NEXAVAR
NDA #021923		 SUPPL-19 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
12/06/2018 NEXAVAR
NDA #021923		 SUPPL-20 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
12/06/2018 TYKERB
NDA #022059		 SUPPL-23 LAPATINIB DITOSYLATE NOVARTIS Efficacy Approval
12/06/2018 TYKERB
NDA #022059		 SUPPL-24 LAPATINIB DITOSYLATE NOVARTIS Labeling Approval
12/06/2018 LITHIUM CARBONATE
ANDA #076490		 SUPPL-10 LITHIUM CARBONATE HIKMA INTL PHARMS Labeling Approval
12/06/2018 HUMIRA
BLA #125057		 SUPPL-410 ADALIMUMAB ABBVIE INC Approval
12/06/2018 LITHIUM CARBONATE
ANDA #202219		 SUPPL-2 LITHIUM CARBONATE MYLAN PHARMS INC Labeling Approval
12/06/2018 XALKORI
NDA #202570		 SUPPL-27 CRIZOTINIB PF PRISM CV Labeling Approval
12/06/2018 ADEMPAS
NDA #204819		 SUPPL-9 RIOCIGUAT BAYER HLTHCARE REMS Approval
12/06/2018 MONTELUKAST SODIUM
ANDA #207464		 ORIG-1 MONTELUKAST SODIUM CHARTWELL MOLECULAR Approval
12/06/2018 PALONOSETRON HYDROCHLORIDE
NDA #208109		 SUPPL-1 PALONOSETRON HYDROCHLORIDE FRESENIUS KABI USA Efficacy Approval
12/06/2018 AZITHROMYCIN
ANDA #209043		 ORIG-1 AZITHROMYCIN SUNSHINE Approval
12/06/2018 PROGESTERONE
ANDA #210965		 ORIG-1 PROGESTERONE EUGIA PHARMA Approval
12/06/2018 TECENTRIQ
BLA #761034		 SUPPL-9 ATEZOLIZUMAB GENENTECH INC Approval
12/07/2018 NASCOBAL
NDA #021642		 SUPPL-19 CYANOCOBALAMIN ENDO PHARMS INC Labeling Approval
12/07/2018 MOVIPREP
NDA #021881		 SUPPL-17 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE SALIX PHARMS Labeling Approval
12/07/2018 LITHIUM CARBONATE
ANDA #076366		 SUPPL-5 LITHIUM CARBONATE HERITAGE PHARMA Labeling Approval
12/07/2018 LITHIUM CARBONATE
ANDA #076691		 SUPPL-8 LITHIUM CARBONATE HIKMA Labeling Approval
12/07/2018 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077215		 ORIG-1 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CIPLA Approval
12/07/2018 ATORVASTATIN CALCIUM
ANDA #077575		 SUPPL-10 ATORVASTATIN CALCIUM SANDOZ INC Labeling Approval
12/07/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #079013		 SUPPL-6 ALFUZOSIN HYDROCHLORIDE APOTEX INC Labeling Approval
12/07/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #079054		 SUPPL-15 ALFUZOSIN HYDROCHLORIDE TORRENT PHARMS Labeling Approval
12/07/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #079060		 SUPPL-10 ALFUZOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/07/2018 LITHIUM CARBONATE
ANDA #091616		 SUPPL-7 LITHIUM CARBONATE GLENMARK PHARMS LTD Labeling Approval
12/07/2018 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #202131		 SUPPL-2 DROSPIRENONE; ETHINYL ESTRADIOL MYLAN LABS LTD Labeling Approval
12/07/2018 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #202131		 SUPPL-5 DROSPIRENONE; ETHINYL ESTRADIOL MYLAN LABS LTD Labeling Approval
12/07/2018 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #202131		 SUPPL-6 DROSPIRENONE; ETHINYL ESTRADIOL MYLAN LABS LTD Labeling Approval
12/07/2018 LEVETIRACETAM
ANDA #202167		 SUPPL-4 LEVETIRACETAM DEXCEL Labeling Approval
12/07/2018 LEVETIRACETAM
ANDA #202167		 SUPPL-5 LEVETIRACETAM DEXCEL Labeling Approval
12/07/2018 LEVETIRACETAM
ANDA #202167		 SUPPL-6 LEVETIRACETAM DEXCEL Labeling Approval
12/07/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #203192		 SUPPL-6 ALFUZOSIN HYDROCHLORIDE UNICHEM Labeling Approval
12/07/2018 ERGOCALCIFEROL
ANDA #204276		 ORIG-1 ERGOCALCIFEROL PURACAP PHARM LLC Approval
12/07/2018 LITHIUM CARBONATE
ANDA #205663		 SUPPL-1 LITHIUM CARBONATE UNIQUE Labeling Approval
12/07/2018 LENVIMA
NDA #206947		 SUPPL-9 LENVATINIB MESYLATE EISAI INC Labeling Approval
12/07/2018 AZITHROMYCIN
ANDA #209044		 ORIG-1 AZITHROMYCIN SUNSHINE Approval
12/07/2018 AZITHROMYCIN
ANDA #209045		 ORIG-1 AZITHROMYCIN SUNSHINE Approval
12/07/2018 OLOPATADINE HYDROCHLORIDE
ANDA #209919		 ORIG-1 OLOPATADINE HYDROCHLORIDE ALEMBIC Approval
12/07/2018 ALBENDAZOLE
ANDA #210011		 ORIG-1 ALBENDAZOLE STRIDES PHARMA Approval
12/07/2018 APIXABAN
ANDA #210119		 ORIG-1 APIXABAN LUPIN PHARMS Tentative Approval
12/07/2018 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #211352		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ELITE LABS INC Approval
12/10/2018 LUPRON
NDA #019010		 SUPPL-41 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
12/10/2018 LUPRON DEPOT
NDA #019732		 SUPPL-43 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
12/10/2018 LUPRON DEPOT
NDA #020517		 SUPPL-41 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
12/10/2018 UNITHROID
NDA #021210		 SUPPL-8 LEVOTHYROXINE SODIUM STEVENS J Labeling Approval
12/10/2018 EMTRIVA
NDA #021500		 SUPPL-29 EMTRICITABINE GILEAD Labeling Approval
12/10/2018 EMTRIVA
NDA #021896		 SUPPL-26 EMTRICITABINE GILEAD Labeling Approval
12/10/2018 MERCAPTOPURINE
ANDA #040594		 SUPPL-10 MERCAPTOPURINE MYLAN Labeling Approval
12/10/2018 LORAZEPAM
ANDA #071141		 SUPPL-50 LORAZEPAM SANDOZ Labeling Approval
12/10/2018 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-14 ENALAPRIL MALEATE AIPING PHARM INC Labeling Approval
12/10/2018 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-15 ENALAPRIL MALEATE AIPING PHARM INC Labeling Approval
12/10/2018 BIMATOPROST
ANDA #201894		 SUPPL-3 BIMATOPROST APOTEX Manufacturing (CMC) Approval
12/10/2018 CELECOXIB
ANDA #207061		 SUPPL-2 CELECOXIB JUBILANT GENERICS Labeling Approval
12/10/2018 GENVOYA
NDA #207561		 SUPPL-18 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/10/2018 SILODOSIN
ANDA #210626		 ORIG-1 SILODOSIN AUROBINDO PHARMA LTD Approval
12/11/2018 LOVENOX
NDA #020164		 SUPPL-116 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
12/11/2018 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-116 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
12/11/2018 HUMALOG
BLA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Approval
12/11/2018 HUMALOG KWIKPEN
BLA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Approval
12/11/2018 HUMALOG PEN
BLA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Approval
12/11/2018 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Approval
12/11/2018 IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140		 SUPPL-26 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE J AND J CONSUMER INC Labeling Approval
12/11/2018 VIREAD
NDA #021356		 SUPPL-57 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/11/2018 PLIAGLIS
NDA #021717		 SUPPL-10 LIDOCAINE; TETRACAINE TARO Labeling Approval
12/11/2018 DACOGEN
NDA #021790		 SUPPL-20 DECITABINE OTSUKA Labeling Approval
12/11/2018 ZOLINZA
NDA #021991		 SUPPL-9 VORINOSTAT MSD SUB MERCK Labeling Approval
12/11/2018 VIREAD
NDA #022577		 SUPPL-13 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/11/2018 GEMFIBROZIL
ANDA #079072		 SUPPL-11 GEMFIBROZIL NORTHSTAR HLTHCARE Labeling Approval
12/11/2018 GEMFIBROZIL
ANDA #079072		 SUPPL-12 GEMFIBROZIL NORTHSTAR HLTHCARE Labeling Approval
12/11/2018 ZEVALIN
BLA #125019		 SUPPL-227 IBRITUMOMAB TIUXETAN SPECTRUM PHARMS Approval
12/11/2018 TOLSURA
NDA #208901		 ORIG-1 ITRACONAZOLE MAYNE PHARMA Type 5 - New Formulation or New Manufacturer Approval
12/11/2018 LIDOCAINE
ANDA #210958		 ORIG-1 LIDOCAINE STRIDES PHARMA Approval
12/11/2018 BRINEURA
BLA #761052		 SUPPL-3 CERLIPONASE ALFA BIOMARIN PHARM Approval
12/12/2018 ANTIVERT
NDA #010721		 SUPPL-62 MECLIZINE HYDROCHLORIDE CASPER PHARMA LLC Labeling Approval
12/12/2018 FLOLAN
NDA #020444		 SUPPL-24 EPOPROSTENOL SODIUM GLAXOSMITHKLINE LLC Labeling Approval
12/12/2018 DEFINITY
NDA #021064		 SUPPL-22 PERFLUTREN LANTHEUS MEDCL Labeling Approval
12/12/2018 DEFINITY RT
NDA #021064		 SUPPL-22 PERFLUTREN LANTHEUS MEDCL Labeling Approval
12/12/2018 TAMIFLU
NDA #021087		 SUPPL-70 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
12/12/2018 TAMIFLU
NDA #021246		 SUPPL-53 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
12/12/2018 EXJADE
NDA #021882		 SUPPL-28 DEFERASIROX NOVARTIS Efficacy Approval
12/12/2018 EXJADE
NDA #021882		 SUPPL-29 DEFERASIROX NOVARTIS Labeling Approval
12/12/2018 SOMATULINE DEPOT
NDA #022074		 SUPPL-22 LANREOTIDE ACETATE IPSEN PHARMA Labeling Approval
12/12/2018 VELETRI
NDA #022260		 SUPPL-10 EPOPROSTENOL SODIUM ACTELION Labeling Approval
12/12/2018 PRIMAXIN
NDA #050587		 SUPPL-81 CILASTATIN SODIUM; IMIPENEM MERCK Labeling Approval
12/12/2018 JADENU
NDA #206910		 SUPPL-9 DEFERASIROX NOVARTIS PHARMS CORP Efficacy Approval
12/12/2018 JADENU
NDA #206910		 SUPPL-11 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
12/12/2018 JADENU SPRINKLE
NDA #207968		 SUPPL-4 DEFERASIROX NOVARTIS Efficacy Approval
12/12/2018 JADENU SPRINKLE
NDA #207968		 SUPPL-6 DEFERASIROX NOVARTIS Labeling Approval
12/12/2018 LURASIDONE HYDROCHLORIDE
ANDA #207995		 ORIG-1 LURASIDONE HYDROCHLORIDE FIRST TIME US GENERICS LLC Tentative Approval
12/12/2018 SIKLOS
NDA #208843		 SUPPL-1 HYDROXYUREA THERAVIA Labeling Approval
12/12/2018 ALOGLIPTIN
ANDA #210159		 ORIG-1 ALOGLIPTIN TORRENT PHARMA INC Tentative Approval
12/12/2018 EPIDIOLEX
NDA #210365		 SUPPL-2 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
12/12/2018 LIDOCAINE
ANDA #211019		 ORIG-1 LIDOCAINE COSETTE Approval
12/13/2018 ARIMIDEX
NDA #020541		 SUPPL-31 ANASTROZOLE ANI PHARMS Labeling Approval
12/13/2018 FACTIVE
NDA #021158		 SUPPL-24 GEMIFLOXACIN MESYLATE LG CHEM LTD Labeling Approval
12/13/2018 SUTENT
NDA #021938		 SUPPL-35 SUNITINIB MALATE CPPI CV Labeling Approval
12/13/2018 GEMFIBROZIL
ANDA #078012		 SUPPL-17 GEMFIBROZIL CARIBE HOLDINGS Labeling Approval
12/13/2018 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201524		 SUPPL-12 HYDROCHLOROTHIAZIDE; IRBESARTAN LUPIN LTD Labeling Approval
12/13/2018 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #201524		 SUPPL-12 IRBESARTAN; HYDROCHLOROTHIAZIDE LUPIN LTD Labeling Approval
12/13/2018 OXTELLAR XR
NDA #202810		 SUPPL-10 OXCARBAZEPINE SUPERNUS PHARMS Efficacy Approval
12/13/2018 IRBESARTAN
ANDA #203081		 SUPPL-11 IRBESARTAN AUROBINDO PHARMA LTD Labeling Approval
12/13/2018 GEMFIBROZIL
ANDA #203266		 SUPPL-4 GEMFIBROZIL CADILA PHARMS LTD Labeling Approval
12/13/2018 SAXAGLIPTIN
ANDA #205902		 ORIG-1 SAXAGLIPTIN WATSON LABS Tentative Approval
12/13/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208861		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
12/13/2018 LEVORPHANOL TARTRATE
ANDA #211484		 ORIG-1 LEVORPHANOL TARTRATE VIRTUS Approval
12/14/2018 TRELSTAR
NDA #020715		 SUPPL-40 TRIPTORELIN PAMOATE VERITY Labeling Approval
12/14/2018 ZOMETA
NDA #021223		 SUPPL-41 ZOLEDRONIC ACID NOVARTIS Labeling Approval
12/14/2018 TRELSTAR
NDA #021288		 SUPPL-35 TRIPTORELIN PAMOATE VERITY Labeling Approval
12/14/2018 TRELSTAR
NDA #022437		 SUPPL-15 TRIPTORELIN PAMOATE VERITY Labeling Approval
12/14/2018 NPLATE
BLA #125268		 SUPPL-163 ROMIPLOSTIM AMGEN Approval
12/14/2018 ALBENDAZOLE
ANDA #208979		 ORIG-1 ALBENDAZOLE ZYDUS PHARMS Approval
12/14/2018 MOTEGRITY
NDA #210166		 ORIG-1 PRUCALOPRIDE SUCCINATE TAKEDA PHARMS USA Type 1 - New Molecular Entity Approval
12/14/2018 CLOBAZAM
ANDA #210545		 ORIG-1 CLOBAZAM LUPIN LTD Approval
12/14/2018 HEPARIN SODIUM
ANDA #211005		 ORIG-1 HEPARIN SODIUM NANJING KING-FRIEND Approval
12/14/2018 HYDROCORTISONE VALERATE
ANDA #211750		 ORIG-1 HYDROCORTISONE VALERATE GLENMARK PHARMS LTD Approval
12/14/2018 FLUOCINONIDE ACETONIDE
ANDA #211815		 ORIG-1 FLUOCINOLONE ACETONIDE GLENMARK PHARMS LTD Approval
12/14/2018 HERZUMA
BLA #761091		 ORIG-1 TRASTUZUMAB-PKRB CELLTRION INC Approval
12/17/2018 MESNEX
NDA #019884		 SUPPL-16 MESNA BAXTER HLTHCARE Labeling Approval
12/17/2018 VIDEX
NDA #020156		 SUPPL-54 DIDANOSINE BRISTOL Labeling Approval
12/17/2018 ZERIT
NDA #020412		 SUPPL-41 STAVUDINE BRISTOL Labeling Approval
12/17/2018 ZERIT
NDA #020413		 SUPPL-33 STAVUDINE BRISTOL Labeling Approval
12/17/2018 MESNEX
NDA #020855		 SUPPL-3 MESNA BAXTER HLTHCARE Labeling Approval
12/17/2018 VIDEX EC
NDA #021183		 SUPPL-29 DIDANOSINE BRISTOL MYERS SQUIBB Labeling Approval
12/17/2018 NATPARA
BLA #125511		 SUPPL-16 PARATHYROID HORMONE NPS PHARMS INC Approval
12/17/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #202467		 SUPPL-9 PIOGLITAZONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
12/17/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #202467		 SUPPL-12 PIOGLITAZONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
12/17/2018 LINEZOLID
ANDA #205233		 SUPPL-1 LINEZOLID ALEMBIC Labeling Approval
12/17/2018 LINEZOLID
ANDA #205233		 SUPPL-3 LINEZOLID ALEMBIC Labeling Approval
12/17/2018 NALOXONE HYDROCHLORIDE
ANDA #207846		 ORIG-1 NALOXONE HYDROCHLORIDE CHARTWELL RX Approval
12/17/2018 NOREPINEPHRINE BITARTRATE
ANDA #210839		 ORIG-1 NOREPINEPHRINE BITARTRATE AMNEAL Approval
12/18/2018 KINEVAC
NDA #017697		 SUPPL-33 SINCALIDE BRACCO Labeling Approval
12/18/2018 FAMVIR
NDA #020363		 SUPPL-50 FAMCICLOVIR NOVARTIS Labeling Approval
12/18/2018 ARICEPT
NDA #020690		 SUPPL-42 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
12/18/2018 EXELON
NDA #020823		 SUPPL-36 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
12/18/2018 EXELON
NDA #021025		 SUPPL-24 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
12/18/2018 ARICEPT ODT
NDA #021720		 SUPPL-14 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
12/18/2018 MEGACE ES
NDA #021778		 SUPPL-24 MEGESTROL ACETATE ENDO PHARMS INC Labeling Approval
12/18/2018 EXELON
NDA #022083		 SUPPL-26 RIVASTIGMINE SANDOZ Labeling Approval
12/18/2018 ARICEPT
NDA #022568		 SUPPL-11 DONEPEZIL HYDROCHLORIDE EISAI INC Labeling Approval
12/18/2018 KEFLEX
NDA #050405		 SUPPL-107 CEPHALEXIN PRAGMA Labeling Approval
12/18/2018 KEFLEX
NDA #050406		 SUPPL-13 CEPHALEXIN PRAGMA Labeling Approval
12/18/2018 FABRAZYME
BLA #103979		 SUPPL-5303 AGALSIDASE BETA GENZYME Approval
12/18/2018 PERJETA
BLA #125409		 SUPPL-123 PERTUZUMAB GENENTECH Approval
12/18/2018 KADCYLA
BLA #125427		 SUPPL-104 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
12/18/2018 GATTEX KIT
NDA #203441		 SUPPL-12 TEDUGLUTIDE TAKEDA PHARMS USA Efficacy Approval
12/18/2018 EZALLOR SPRINKLE
NDA #208647		 ORIG-1 ROSUVASTATIN CALCIUM SUN PHARM Type 5 - New Formulation or New Manufacturer Approval
12/18/2018 CYANOCOBALAMIN
ANDA #209255		 ORIG-1 CYANOCOBALAMIN VITRUVIAS THERAP Approval
12/18/2018 CYANOCOBALAMIN
ANDA #209429		 ORIG-1 CYANOCOBALAMIN SOMERSET THERAPS LLC Approval
12/18/2018 GEMCITABINE HYDROCHLORIDE
NDA #209604		 SUPPL-2 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
12/19/2018 AGRYLIN
NDA #020333		 SUPPL-25 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
12/19/2018 VENOFER
NDA #021135		 SUPPL-35 FERRIC OXYHYDROXIDE AM REGENT Labeling Approval
12/19/2018 INVANZ
NDA #021337		 SUPPL-47 ERTAPENEM SODIUM MSD SUB MERCK Labeling Approval
12/19/2018 VEREGEN
NDA #021902		 SUPPL-33 SINECATECHINS ANI PHARMS Labeling Approval
12/19/2018 AVEED
NDA #022219		 SUPPL-12 TESTOSTERONE UNDECANOATE ENDO PHARMS INC REMS Approval
12/19/2018 KEFLEX
NDA #050405		 SUPPL-108 CEPHALEXIN PRAGMA Labeling Approval
12/19/2018 BIAXIN
NDA #050662		 SUPPL-60 CLARITHROMYCIN ABBVIE Labeling Approval
12/19/2018 BIAXIN
NDA #050698		 SUPPL-40 CLARITHROMYCIN ABBVIE Labeling Approval
12/19/2018 BIAXIN XL
NDA #050775		 SUPPL-28 CLARITHROMYCIN ABBVIE Labeling Approval
12/19/2018 KEYTRUDA
BLA #125514		 SUPPL-45 PEMBROLIZUMAB MERCK SHARP DOHME Approval
12/19/2018 ZOLEDRONIC ACID
NDA #204016		 SUPPL-3 ZOLEDRONIC ACID HOSPIRA Labeling Approval
12/19/2018 ENVARSUS XR
NDA #206406		 SUPPL-7 TACROLIMUS VELOXIS PHARMS INC Efficacy Approval
12/19/2018 BENZONATATE
ANDA #206948		 ORIG-1 BENZONATATE PURACAP PHARM LLC Approval
12/19/2018 LICART
NDA #206976		 ORIG-1 DICLOFENAC EPOLAMINE IBSA INST BIO Type 3 - New Dosage Form and Type 4 - New Combination Approval
12/19/2018 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #207011		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE UNICHEM Approval
12/19/2018 METOPROLOL SUCCINATE
ANDA #207206		 ORIG-1 METOPROLOL SUCCINATE VISUM PHARM Approval
12/19/2018 LYNPARZA
NDA #208558		 SUPPL-6 OLAPARIB ASTRAZENECA Efficacy Approval
12/19/2018 ALOGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA #210160		 ORIG-1 ALOGLIPTIN; METFORMIN HYDROCHLORIDE TORRENT PHARMS LTD Tentative Approval
12/19/2018 POTASSIUM CHLORIDE
ANDA #210921		 ORIG-1 POTASSIUM CHLORIDE AUROBINDO PHARMA Approval
12/20/2018 IMURAN
NDA #016324		 SUPPL-39 AZATHIOPRINE SEBELA IRELAND LTD Labeling Approval
12/20/2018 IMURAN
NDA #017391		 SUPPL-17 AZATHIOPRINE SODIUM CASPER PHARMA LLC Labeling Approval
12/20/2018 LITHIUM CARBONATE
NDA #017812		 SUPPL-33 LITHIUM CARBONATE HIKMA Labeling Approval
12/20/2018 LITHOBID
NDA #018027		 SUPPL-65 LITHIUM CARBONATE ANI PHARMS Labeling Approval
12/20/2018 LITHIUM CITRATE
NDA #018421		 SUPPL-32 LITHIUM CITRATE HIKMA Labeling Approval
12/20/2018 LITHIUM CARBONATE
NDA #018558		 SUPPL-27 LITHIUM CARBONATE HIKMA Labeling Approval
12/20/2018 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-62 HEPARIN SODIUM HOSPIRA Labeling Approval
12/20/2018 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-62 HEPARIN SODIUM HOSPIRA Labeling Approval
12/20/2018 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019339		 SUPPL-62 HEPARIN SODIUM HOSPIRA Labeling Approval
12/20/2018 GLUCAGON
NDA #020928		 SUPPL-57 GLUCAGON LILLY Labeling Approval
12/20/2018 NOVOLOG
BLA #020986		 SUPPL-87 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-87 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-87 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG INNOLET
BLA #020986		 SUPPL-87 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG PENFILL
BLA #020986		 SUPPL-87 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-68 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-68 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-68 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
12/20/2018 LEVOXYL
NDA #021301		 SUPPL-38 LEVOTHYROXINE SODIUM KING PHARMS Labeling Approval
12/20/2018 APIDRA
BLA #021629		 SUPPL-37 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
12/20/2018 APIDRA
BLA #021629		 SUPPL-38 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
12/20/2018 APIDRA SOLOSTAR
BLA #021629		 SUPPL-37 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
12/20/2018 APIDRA SOLOSTAR
BLA #021629		 SUPPL-38 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
12/20/2018 AZILECT
NDA #021641		 SUPPL-20 RASAGILINE MESYLATE TEVA Labeling Approval
12/20/2018 BYETTA
NDA #021773		 SUPPL-41 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
12/20/2018 BARACLUDE
NDA #021797		 SUPPL-21 ENTECAVIR BRISTOL MYERS SQUIBB Labeling Approval
12/20/2018 BARACLUDE
NDA #021798		 SUPPL-23 ENTECAVIR BRISTOL MYERS SQUIBB Labeling Approval
12/20/2018 CLEOCIN
NDA #050680		 SUPPL-16 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
12/20/2018 TOBI
NDA #050753		 SUPPL-23 TOBRAMYCIN MYLAN SPECIALITY LP Labeling Approval
12/20/2018 CLEOCIN
NDA #050767		 SUPPL-15 CLINDAMYCIN PHOSPHATE PFIZER Labeling Approval
12/20/2018 LITHIUM CARBONATE
ANDA #076366		 SUPPL-6 LITHIUM CARBONATE HERITAGE PHARMA Labeling Approval
12/20/2018 LITHIUM CARBONATE
ANDA #076490		 SUPPL-11 LITHIUM CARBONATE HIKMA INTL PHARMS Labeling Approval
12/20/2018 LITHIUM CARBONATE
ANDA #076691		 SUPPL-9 LITHIUM CARBONATE HIKMA Labeling Approval
12/20/2018 LITHIUM CARBONATE
ANDA #091616		 SUPPL-8 LITHIUM CARBONATE GLENMARK PHARMS LTD Labeling Approval
12/20/2018 ARANESP
BLA #103951		 SUPPL-5377 DARBEPOETIN ALFA AMGEN Approval
12/20/2018 ACTEMRA
BLA #125276		 SUPPL-125 TOCILIZUMAB GENENTECH Approval
12/20/2018 ACTEMRA
BLA #125472		 SUPPL-38 TOCILIZUMAB GENENTECH Approval
12/20/2018 LITHIUM CARBONATE
ANDA #202219		 SUPPL-3 LITHIUM CARBONATE MYLAN PHARMS INC Labeling Approval
12/20/2018 ELEPSIA XR
NDA #204417		 ORIG-1 LEVETIRACETAM TRIPOINT Type 5 - New Formulation or New Manufacturer Approval
12/20/2018 LITHIUM CARBONATE
ANDA #205663		 SUPPL-2 LITHIUM CARBONATE UNIQUE Labeling Approval
12/20/2018 VECURONIUM BROMIDE
ANDA #206670		 ORIG-1 VECURONIUM BROMIDE EUGIA PHARMA Approval
12/20/2018 ASPARLAS
BLA #761102		 ORIG-1 CALASPARGASE PEGOL-MKNL SERVIER PHARMA LLC Approval
12/21/2018 CYTOMEL
NDA #010379		 SUPPL-54 LIOTHYRONINE SODIUM KING PHARMS Labeling Approval
12/21/2018 CLARITIN
NDA #019658		 SUPPL-55 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
12/21/2018 CLARITIN HIVES RELIEF
NDA #019658		 SUPPL-55 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
12/21/2018 AMARYL
NDA #020496		 SUPPL-29 GLIMEPIRIDE SANOFI AVENTIS US Labeling Approval
12/21/2018 SEREVENT
NDA #020692		 SUPPL-46 SALMETEROL XINAFOATE GLAXOSMITHKLINE Labeling Approval
12/21/2018 ZOMIG
NDA #020768		 SUPPL-23 ZOLMITRIPTAN IPR Labeling Approval
12/21/2018 SINGULAIR
NDA #020829		 SUPPL-70 MONTELUKAST SODIUM ORGANON Labeling Approval
12/21/2018 SINGULAIR
NDA #020829		 SUPPL-71 MONTELUKAST SODIUM ORGANON Labeling Approval
12/21/2018 SINGULAIR
NDA #020830		 SUPPL-72 MONTELUKAST SODIUM ORGANON Labeling Approval
12/21/2018 SINGULAIR
NDA #020830		 SUPPL-73 MONTELUKAST SODIUM ORGANON Labeling Approval
12/21/2018 ANGIOMAX
NDA #020873		 SUPPL-37 BIVALIRUDIN SANDOZ Labeling Approval
12/21/2018 PEPCID COMPLETE
NDA #020958		 SUPPL-27 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE J AND J CONSUMER INC Labeling Approval
12/21/2018 SANDOSTATIN LAR
NDA #021008		 SUPPL-36 OCTREOTIDE ACETATE NOVARTIS Labeling Approval
12/21/2018 ZOMIG-ZMT
NDA #021231		 SUPPL-14 ZOLMITRIPTAN ASTRAZENECA Labeling Approval
12/21/2018 SINGULAIR
NDA #021409		 SUPPL-48 MONTELUKAST SODIUM ORGANON Labeling Approval
12/21/2018 SINGULAIR
NDA #021409		 SUPPL-49 MONTELUKAST SODIUM ORGANON Labeling Approval
12/21/2018 ZOMIG
NDA #021450		 SUPPL-10 ZOLMITRIPTAN AMNEAL Labeling Approval
12/21/2018 ROZEREM
NDA #021782		 SUPPL-21 RAMELTEON TAKEDA PHARMS USA Labeling Approval
12/21/2018 DACOGEN
NDA #021790		 SUPPL-21 DECITABINE OTSUKA Labeling Approval
12/21/2018 CLOBEX
NDA #021835		 SUPPL-15 CLOBETASOL PROPIONATE GALDERMA LABS LP Labeling Approval
12/21/2018 TACLONEX
NDA #021852		 SUPPL-20 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
12/21/2018 CLARITIN
NDA #021952		 SUPPL-18 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
12/21/2018 SPRYCEL
NDA #021986		 SUPPL-21 DASATINIB BRISTOL MYERS SQUIBB Efficacy Approval
12/21/2018 PEGINTRON
BLA #103949		 SUPPL-5312 PEGINTERFERON ALFA-2B SCHERING Approval
12/21/2018 SYLATRON
BLA #103949		 SUPPL-5312 PEGINTERFERON ALFA-2B SCHERING Approval
12/21/2018 MYALEPT
BLA #125390		 SUPPL-14 METRELEPTIN AMRYT Approval
12/21/2018 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #202132		 SUPPL-3 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN LABS LTD Labeling Approval
12/21/2018 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #202132		 SUPPL-4 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN LABS LTD Labeling Approval
12/21/2018 LORATADINE
ANDA #202538		 ORIG-1 LORATADINE BIONPHARMA Approval
12/21/2018 ATOVAQUONE
ANDA #202960		 SUPPL-2 ATOVAQUONE AMNEAL PHARMS Labeling Approval
12/21/2018 ATOVAQUONE
ANDA #202960		 SUPPL-5 ATOVAQUONE AMNEAL PHARMS Labeling Approval
12/21/2018 RAVICTI
NDA #203284		 SUPPL-10 GLYCEROL PHENYLBUTYRATE HORIZON THERAP US Efficacy Approval
12/21/2018 BRETYLIUM TOSYLATE
ANDA #204386		 ORIG-1 BRETYLIUM TOSYLATE BRECKENRIDGE Approval
12/21/2018 TIGECYCLINE
ANDA #204439		 ORIG-1 TIGECYCLINE APOTEX Approval
12/21/2018 LINEZOLID
ANDA #204536		 SUPPL-1 LINEZOLID AMNEAL PHARMS Labeling Approval
12/21/2018 LINEZOLID
ANDA #204536		 SUPPL-2 LINEZOLID AMNEAL PHARMS Labeling Approval
12/21/2018 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
ANDA #204558		 ORIG-1 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS STRIDES PHARMA Approval
12/21/2018 JARDIANCE
NDA #204629		 SUPPL-19 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Labeling Approval
12/21/2018 DOXYCYCLINE HYCLATE
ANDA #206772		 ORIG-1 DOXYCYCLINE HYCLATE ZYDUS PHARMS Approval
12/21/2018 NEVIRAPINE
ANDA #207684		 SUPPL-1 NEVIRAPINE CIPLA Labeling Approval
12/21/2018 LEVOTHYROXINE SODIUM
ANDA #208749		 ORIG-1 LEVOTHYROXINE SODIUM MAIA PHARMS INC Approval
12/21/2018 ALUNBRIG
NDA #208772		 SUPPL-4 BRIGATINIB TAKEDA PHARMS USA Efficacy Approval
12/21/2018 INBRIJA
NDA #209184		 ORIG-1 LEVODOPA ACORDA Type 3 - New Dosage Form Approval
12/21/2018 ATORVASTATIN CALCIUM
ANDA #209288		 ORIG-1 ATORVASTATIN CALCIUM ALKEM LABS LTD Approval
12/21/2018 ATOVAQUONE
ANDA #209750		 SUPPL-1 ATOVAQUONE APOTEX Labeling Approval
12/21/2018 PHENYLEPHRINE HYDROCHLORIDE
ANDA #210025		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE PAR STERILE PRODUCTS Approval
12/21/2018 AMMONIA N 13
ANDA #210524		 ORIG-1 AMMONIA N-13 IONETIX Approval
12/21/2018 DESOXIMETASONE
ANDA #210980		 ORIG-1 DESOXIMETASONE RISING Approval
12/21/2018 ULTOMIRIS
BLA #761108		 ORIG-1 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
12/21/2018 ELZONRIS
BLA #761116		 ORIG-1 TAGRAXOFUSP-ERZS STEMLINE THERAPEUTICS INC Approval
12/26/2018 GRISEOFULVIN, ULTRAMICROSIZE
ANDA #202805		 ORIG-1 GRISEOFULVIN, ULTRAMICROSIZE SANDOZ Approval
12/26/2018 ARIPIPRAZOLE
ANDA #208260		 ORIG-1 ARIPIPRAZOLE PHARMTAK INC Tentative Approval
12/26/2018 ARIPIPRAZOLE
ANDA #208438		 ORIG-1 ARIPIPRAZOLE PHARMTAK INC Tentative Approval
12/26/2018 AZITHROMYCIN
ANDA #209999		 ORIG-1 AZITHROMYCIN BIONPHARMA Approval
12/26/2018 CLOBETASOL PROPIONATE
ANDA #211256		 ORIG-1 CLOBETASOL PROPIONATE AMNEAL Approval
12/27/2018 TOPAMAX
NDA #020505		 SUPPL-59 TOPIRAMATE JANSSEN PHARMS Labeling Approval
12/27/2018 TOPAMAX
NDA #020844		 SUPPL-50 TOPIRAMATE JANSSEN PHARMS Labeling Approval
12/27/2018 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-50 TOPIRAMATE JANSSEN PHARMS Labeling Approval
12/27/2018 GLUCOVANCE
NDA #021178		 SUPPL-18 GLYBURIDE; METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB Labeling Approval
12/27/2018 FUZEON
NDA #021481		 SUPPL-32 ENFUVIRTIDE ROCHE Labeling Approval
12/27/2018 TYZEKA
NDA #022011		 SUPPL-22 TELBIVUDINE NOVARTIS Labeling Approval
12/27/2018 TYZEKA
NDA #022154		 SUPPL-19 TELBIVUDINE NOVARTIS Labeling Approval
12/27/2018 TRIMIPRAMINE MALEATE
ANDA #077361		 SUPPL-8 TRIMIPRAMINE MALEATE ELITE LABS INC Manufacturing (CMC) Approval
12/27/2018 CINACALCET HYDROCHLORIDE
ANDA #204377		 ORIG-1 CINACALCET HYDROCHLORIDE WATSON LABS TEVA Approval
12/27/2018 OCTREOTIDE ACETATE
ANDA #204669		 ORIG-1 OCTREOTIDE ACETATE HERITAGE PHARMS Approval
12/27/2018 PIMECROLIMUS
ANDA #209345		 ORIG-1 PIMECROLIMUS ACTAVIS LABS UT INC Approval
12/27/2018 METFORMIN HYDROCHLORIDE
ANDA #209993		 ORIG-1 METFORMIN HYDROCHLORIDE QINGDAO BAHEAL PHARM Approval
12/27/2018 CLOFARABINE
ANDA #210283		 ORIG-1 CLOFARABINE HOSPIRA Approval
12/28/2018 HEPSERA
NDA #021449		 SUPPL-24 ADEFOVIR DIPIVOXIL GILEAD Labeling Approval
12/28/2018 VIVITROL
NDA #021897		 SUPPL-42 NALTREXONE ALKERMES Labeling Approval
12/28/2018 KEYTRUDA
BLA #125514		 SUPPL-37 PEMBROLIZUMAB MERCK SHARP DOHME Approval
12/28/2018 EXEMESTANE
ANDA #206421		 ORIG-1 EXEMESTANE AMNEAL PHARMS Approval
12/28/2018 YONDELIS
NDA #207953		 SUPPL-5 TRABECTEDIN JANSSEN PRODS Labeling Approval
12/28/2018 IRINOTECAN HYDROCHLORIDE
ANDA #208718		 ORIG-1 IRINOTECAN HYDROCHLORIDE SHILPA Approval
12/28/2018 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #209587		 SUPPL-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE LGM PHARMA Manufacturing (CMC) Approval
12/28/2018 CLOBAZAM
ANDA #210546		 ORIG-1 CLOBAZAM LUPIN LTD Approval
12/28/2018 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #210794		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE ZYDUS PHARMS Approval
12/28/2018 VERAPAMIL HYDROCHLORIDE
ANDA #211370		 ORIG-1 VERAPAMIL HYDROCHLORIDE MICRO LABS Approval
12/28/2018 PREDNISONE
ANDA #211496		 ORIG-1 PREDNISONE GENEYORK PHARMS Approval
12/29/2018 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #021569		 SUPPL-9 SODIUM CHLORIDE LIEBEL-FLARSHEIM Labeling Approval
12/30/2018 BICALUTAMIDE
ANDA #078917		 SUPPL-7 BICALUTAMIDE ACCORD HLTHCARE Labeling Approval
12/30/2018 BICALUTAMIDE
ANDA #078917		 SUPPL-10 BICALUTAMIDE ACCORD HLTHCARE Labeling Approval
12/31/2018 CYANOKIT
NDA #022041		 SUPPL-19 HYDROXOCOBALAMIN BTG INTL Labeling Approval
12/31/2018 CYANOKIT
NDA #022041		 SUPPL-20 HYDROXOCOBALAMIN BTG INTL Labeling Approval
12/31/2018 ZYFLO CR
NDA #022052		 SUPPL-14 ZILEUTON CHIESI Labeling Approval
12/31/2018 KETAMINE HYDROCHLORIDE
ANDA #076092		 SUPPL-23 KETAMINE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
12/31/2018 SIMVASTATIN
ANDA #077691		 SUPPL-36 SIMVASTATIN AUROBINDO PHARMA Labeling Approval
12/31/2018 SIMVASTATIN
ANDA #078155		 SUPPL-30 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
12/31/2018 LINEZOLID
ANDA #078987		 SUPPL-1 LINEZOLID GLENMARK PHARMS Labeling Approval
12/31/2018 LINEZOLID
ANDA #205517		 SUPPL-1 LINEZOLID ALKEM LABS LTD Labeling Approval
12/31/2018 MORPHABOND ER
NDA #206544		 SUPPL-9 MORPHINE SULFATE OHEMO LIFE Labeling Approval
12/31/2018 MINOXIDIL (FOR MEN)
ANDA #209074		 ORIG-1 MINOXIDIL TARO Approval
12/31/2018 MINOXIDIL (FOR WOMEN)
ANDA #209074		 ORIG-1 MINOXIDIL TARO Approval
12/31/2018 GENTAMICIN SULFATE
ANDA #209233		 ORIG-1 GENTAMICIN SULFATE ENCUBE Approval
12/31/2018 ROXYBOND
NDA #209777		 SUPPL-2 OXYCODONE HYDROCHLORIDE PROTEGA PHARMS Labeling Approval
12/31/2018 FEBUXOSTAT
ANDA #211339		 ORIG-1 FEBUXOSTAT BEIJING SL PHARMA CO LTD Tentative Approval
12/31/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #211499		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ABHAI LLC Approval
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