Drugs@FDA: FDA Approved Drug Products

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All Approvals
December 2018

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on December 16, 2018.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/01/2018 JYNARQUE
NDA #204441		 SUPPL-2 TOLVAPTAN OTSUKA PHARM CO LTD 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 PARKE-DAVIS Labeling Approval
12/03/2018 DILANTIN
ANDA #084427		 SUPPL-42 PHENYTOIN PFIZER Labeling Approval
12/03/2018 NATEGLINIDE
ANDA #205055		 SUPPL-1 NATEGLINIDE ALVOGEN MALTA 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 LABS PVT LTD 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 SUB MERCK Labeling Approval
12/04/2018 NUVARING
NDA #021187		 SUPPL-36 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON SUB MERCK 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 SAXENDA
NDA #206321		 SUPPL-9 LIRAGLUTIDE RECOMBINANT NOVO NORDISK INC REMS Approval
12/04/2018 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #207676		 ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE MAYNE PHARMA INC Approval
12/04/2018 TOREMIFENE CITRATE
ANDA #208813		 ORIG-1 TOREMIFENE CITRATE EIRGEN PHARMA LTD Approval
12/04/2018 CANDESARTAN CILEXETIL
ANDA #210302		 ORIG-1 CANDESARTAN CILEXETIL ALEMBIC PHARMS LTD Approval
12/04/2018 PREDNISONE
ANDA #210525		 ORIG-1 PREDNISONE GENEYORK PHARMS Approval
12/05/2018 GLIADEL
NDA #020637		 SUPPL-29 CARMUSTINE ARBOR PHARMS LLC 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 PHARMS CORP Efficacy Approval
12/06/2018 TYKERB
NDA #022059		 SUPPL-24 LAPATINIB DITOSYLATE NOVARTIS PHARMS CORP 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 CIPLA 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 LAKE Approval
12/06/2018 NITYR
NDA #209449		 SUPPL-5 NITISINONE CYCLE PHARMS LTD Efficacy Tentative 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 BARR Labeling Approval
12/07/2018 LITHIUM CARBONATE
ANDA #076691		 SUPPL-8 LITHIUM CARBONATE WEST-WARD PHARMS INT 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 GENERICS 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 PHARMA Labeling Approval
12/07/2018 LEVETIRACETAM
ANDA #202167		 SUPPL-5 LEVETIRACETAM DEXCEL PHARMA Labeling Approval
12/07/2018 LEVETIRACETAM
ANDA #202167		 SUPPL-6 LEVETIRACETAM DEXCEL PHARMA Labeling Approval
12/07/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #203192		 SUPPL-6 ALFUZOSIN HYDROCHLORIDE UNICHEM LABS LTD 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 PHARM LABS 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 LAKE Approval
12/07/2018 AZITHROMYCIN
ANDA #209045		 ORIG-1 AZITHROMYCIN SUNSHINE LAKE Approval
12/07/2018 OLOPATADINE HYDROCHLORIDE
ANDA #209919		 ORIG-1 OLOPATADINE HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
12/07/2018 ALBENDAZOLE
ANDA #210011		 ORIG-1 ALBENDAZOLE STRIDES VIVIMED 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 SUNGEN PHARMA Approval
12/07/2018 PREDNISONE
ANDA #211495		 ORIG-1 PREDNISONE GENEYORK PHARMS 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 APOTEX Labeling Approval
12/10/2018 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-15 ENALAPRIL MALEATE APOTEX Labeling Approval
12/10/2018 BIMATOPROST
ANDA #201894		 SUPPL-3 BIMATOPROST APOTEX INC 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
NDA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
12/11/2018 HUMALOG KWIKPEN
NDA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
12/11/2018 HUMALOG PEN
NDA #020563		 SUPPL-190 INSULIN LISPRO RECOMBINANT LILLY Labeling 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 PHARMS Labeling Approval
12/11/2018 DACOGEN
NDA #021790		 SUPPL-20 DECITABINE OTSUKA PHARM CO LTD Labeling Approval
12/11/2018 ZOLINZA
NDA #021991		 SUPPL-9 VORINOSTAT 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 EXTAVIA
BLA #125290		 SUPPL-66 INTERFERON BETA-1B NOVARTIS PHARMS Approval
12/11/2018 TOLSURA
NDA #208901		 ORIG-1 ITRACONAZOLE MAYNE PHARMA INC Type 5 - New Formulation or New Manufacturer Approval
12/11/2018 DAPSONE
ANDA #210191		 ORIG-1 DAPSONE TARO PHARMA USA INC Tentative Approval
12/11/2018 DIMETHYL FUMARATE
ANDA #210226		 ORIG-1 DIMETHYL FUMARATE LUPIN ATLANTIS Tentative 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 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 PHARMS LTD 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 PHARMS CORP Efficacy Approval
12/12/2018 JADENU SPRINKLE
NDA #207968		 SUPPL-6 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
12/12/2018 SIKLOS
NDA #208843		 SUPPL-1 HYDROXYUREA ADDMEDICA SAS Labeling Approval
12/12/2018 EPIDIOLEX
NDA #210365		 SUPPL-2 CANNABIDIOL GW RES LTD Labeling Approval
12/12/2018 LIDOCAINE
ANDA #211019		 ORIG-1 LIDOCAINE G AND W LABS INC Approval
12/13/2018 ARIMIDEX
NDA #020541		 SUPPL-31 ANASTROZOLE ANI PHARMS INC 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 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208861		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
12/14/2018 NPLATE
BLA #125268		 SUPPL-163 ROMIPLOSTIM AMGEN Approval
12/14/2018 MOTEGRITY
NDA #210166		 ORIG-1 PRUCALOPRIDE SHIRE DEV LLC Type 1 - New Molecular Entity Approval
12/14/2018 HERZUMA
BLA #761091		 ORIG-1 TRASTUZUMAB-PKRB CELLTRION INC Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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