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 OPERATIONS |
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 |
AMNEAL |
|
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 |
XIROMED |
Labeling |
Approval |
12/07/2018 |
DROSPIRENONE AND ETHINYL ESTRADIOL ANDA #202131 |
SUPPL-5 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
Labeling |
Approval |
12/07/2018 |
DROSPIRENONE AND ETHINYL ESTRADIOL ANDA #202131 |
SUPPL-6 |
DROSPIRENONE; ETHINYL ESTRADIOL |
XIROMED |
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 |
CRESCITA THERAP |
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 OPERATIONS |
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 OPERATIONS |
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 |
XIROMED |
Labeling |
Approval |
12/21/2018 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #202132 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
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 |
MERZ PHARMS GMBH |
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 |
ENDO OPERATIONS |
|
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 |
|
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 SPECLT |
Labeling |
Approval |
12/31/2018 |
LINEZOLID ANDA #078987 |
SUPPL-3 |
LINEZOLID |
GLENMARK SPECLT |
Labeling |
Approval |
12/31/2018 |
LINEZOLID ANDA #078987 |
SUPPL-4 |
LINEZOLID |
GLENMARK SPECLT |
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 |