06/01/2017 |
SAMSCA NDA #022275 |
SUPPL-15 |
TOLVAPTAN |
OTSUKA |
Labeling |
Approval |
06/01/2017 |
CEFPROZIL ANDA #065327 |
SUPPL-1 |
CEFPROZIL |
APOTEX INC |
Labeling |
Approval |
06/01/2017 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE ANDA #070765 |
SUPPL-23 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
ANDA REPOSITORY |
Labeling |
Approval |
06/01/2017 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE ANDA #070766 |
SUPPL-19 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
ANDA REPOSITORY |
Labeling |
Approval |
06/01/2017 |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ANDA #075618 |
SUPPL-25 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
HIKMA INTL PHARMS |
Labeling |
Approval |
06/01/2017 |
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #076236 |
SUPPL-8 |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
BARR |
Manufacturing (CMC) |
Tentative Approval |
06/01/2017 |
OXYCODONE HYDROCHLORIDE ANDA #090895 |
SUPPL-8 |
OXYCODONE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
06/01/2017 |
OXYCODONE HYDROCHLORIDE ANDA #091313 |
SUPPL-5 |
OXYCODONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
06/01/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #201013 |
SUPPL-7 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
06/01/2017 |
LANSOPRAZOLE ANDA #202176 |
SUPPL-3 |
LANSOPRAZOLE |
WOCKHARDT |
Labeling |
Approval |
06/01/2017 |
LANSOPRAZOLE ANDA #202176 |
SUPPL-6 |
LANSOPRAZOLE |
WOCKHARDT |
Labeling |
Approval |
06/01/2017 |
MIRTAZAPINE ANDA #205798 |
ORIG-1 |
MIRTAZAPINE |
SQUARE PHARMS |
|
Approval |
06/01/2017 |
LEVOFLOXACIN ANDA #205968 |
ORIG-1 |
LEVOFLOXACIN |
ZYDUS PHARMS |
|
Approval |
06/02/2017 |
NADOLOL ANDA #208832 |
ORIG-1 |
NADOLOL |
AMNEAL PHARMS CO |
|
Approval |
06/05/2017 |
MESALAMINE ANDA #091640 |
ORIG-1 |
MESALAMINE |
ZYDUS PHARMS |
|
Approval |
06/05/2017 |
NPLATE BLA #125268 |
SUPPL-160 |
ROMIPLOSTIM |
AMGEN |
|
Approval |
06/05/2017 |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE ANDA #203460 |
SUPPL-5 |
MIDAZOLAM HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/05/2017 |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE ANDA #203460 |
SUPPL-6 |
MIDAZOLAM HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
06/05/2017 |
CYANOCOBALAMIN ANDA #204829 |
ORIG-1 |
CYANOCOBALAMIN |
MYLAN LABS LTD |
|
Approval |
06/05/2017 |
LITHIUM CARBONATE ANDA #205663 |
ORIG-1 |
LITHIUM CARBONATE |
UNIQUE |
|
Approval |
06/05/2017 |
ENTACAPONE ANDA #207210 |
ORIG-1 |
ENTACAPONE |
MACLEODS PHARMS LTD |
|
Approval |
06/05/2017 |
ARISTADA NDA #207533 |
SUPPL-4 |
ARIPIPRAZOLE LAUROXIL |
ALKERMES INC |
Efficacy |
Approval |
06/05/2017 |
BUTALBITAL AND ACETAMINOPHEN ANDA #207635 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL |
ALVOGEN |
|
Approval |
06/05/2017 |
DESOGESTREL AND ETHINYL ESTRADIOL ANDA #209170 |
ORIG-1 |
DESOGESTREL; ETHINYL ESTRADIOL |
NAARI PTE LTD |
|
Approval |
06/06/2017 |
HUMALOG BLA #020563 |
SUPPL-176 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
06/06/2017 |
HUMALOG KWIKPEN BLA #020563 |
SUPPL-176 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
06/06/2017 |
HUMALOG PEN BLA #020563 |
SUPPL-176 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
06/06/2017 |
HUMALOG TEMPO PEN BLA #020563 |
SUPPL-176 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
06/06/2017 |
LEFLUNOMIDE ANDA #077087 |
SUPPL-13 |
LEFLUNOMIDE |
WANBANG BIOPHARMS |
Labeling |
Approval |
06/06/2017 |
HUMALOG KWIKPEN BLA #205747 |
SUPPL-10 |
INSULIN LISPRO RECOMBINANT |
ELI LILLY AND CO |
|
Approval |
06/06/2017 |
GLEOLAN NDA #208630 |
ORIG-1 |
AMINOLEVULINIC ACID HYDROCHLORIDE |
NXDC |
Type 3 - New Dosage Form |
Approval |
06/07/2017 |
NORVIR NDA #020659 |
SUPPL-67 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/07/2017 |
NORVIR NDA #022417 |
SUPPL-19 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/07/2017 |
DUEXIS NDA #022519 |
SUPPL-11 |
FAMOTIDINE; IBUPROFEN |
HORIZON |
Labeling |
Approval |
06/07/2017 |
ORENITRAM NDA #203496 |
SUPPL-7 |
TREPROSTINIL DIOLAMINE |
UNITED THERAP |
Labeling |
Approval |
06/07/2017 |
BEPOTASTINE BESILATE ANDA #206080 |
ORIG-1 |
BEPOTASTINE BESILATE |
SANDOZ INC |
|
Tentative Approval |
06/07/2017 |
AMANTADINE HYDROCHLORIDE ANDA #209047 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
06/07/2017 |
NORVIR NDA #209512 |
ORIG-1 |
RITONAVIR |
ABBVIE |
Type 3 - New Dosage Form |
Approval |
06/08/2017 |
LO/OVRAL-28 NDA #017802 |
SUPPL-29 |
ETHINYL ESTRADIOL; NORGESTREL |
WYETH PHARMS |
Labeling |
Approval |
06/08/2017 |
MIRENA NDA #021225 |
SUPPL-38 |
LEVONORGESTREL |
BAYER HLTHCARE |
Efficacy |
Approval |
06/08/2017 |
TRUVADA NDA #021752 |
SUPPL-52 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD |
REMS |
Approval |
06/08/2017 |
CLONIDINE HYDROCHLORIDE ANDA #071785 |
SUPPL-19 |
CLONIDINE HYDROCHLORIDE |
CHARTWELL MOLECULES |
Labeling |
Approval |
06/08/2017 |
GABAPENTIN ANDA #076403 |
SUPPL-2 |
GABAPENTIN |
ACELLA PHARMS LLC |
Labeling |
Approval |
06/08/2017 |
SCANDONEST PLAIN ANDA #088387 |
SUPPL-35 |
MEPIVACAINE HYDROCHLORIDE |
DEPROCO |
Manufacturing (CMC) |
Approval |
06/08/2017 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #090351 |
ORIG-2 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
HIKMA |
|
Approval |
06/08/2017 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE ANDA #090894 |
ORIG-1 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TEVA PHARMS USA |
|
Approval |
06/08/2017 |
DILTIAZEM HYDROCHLORIDE ANDA #203023 |
ORIG-1 |
DILTIAZEM HYDROCHLORIDE |
SUN PHARM |
|
Approval |
06/08/2017 |
NYSTATIN ANDA #208581 |
ORIG-1 |
NYSTATIN |
ZYDUS PHARMS |
|
Approval |
06/08/2017 |
CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE ANDA #209014 |
ORIG-1 |
CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE |
AUROBINDO PHARMA LTD |
|
Tentative Approval |
06/08/2017 |
SILIQ BLA #761032 |
SUPPL-1 |
BRODALUMAB |
VALEANT LUXEMBOURG |
|
Approval |
06/09/2017 |
CUBICIN NDA #021572 |
SUPPL-59 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
06/09/2017 |
CUBICIN RF NDA #021572 |
SUPPL-59 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
06/09/2017 |
VELCADE NDA #021602 |
SUPPL-43 |
BORTEZOMIB |
TAKEDA PHARMS USA |
Labeling |
Approval |
06/09/2017 |
BIAXIN NDA #050662 |
SUPPL-58 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
06/09/2017 |
BIAXIN NDA #050698 |
SUPPL-38 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
06/09/2017 |
BIAXIN XL NDA #050775 |
SUPPL-26 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
06/09/2017 |
MEGESTROL ACETATE ANDA #203960 |
ORIG-1 |
MEGESTROL ACETATE |
HIKMA |
|
Approval |
06/09/2017 |
MEMANTINE HYDROCHLORIDE ANDA #205784 |
ORIG-1 |
MEMANTINE HYDROCHLORIDE |
ENDO OPERATIONS |
|
Approval |
06/09/2017 |
HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE ANDA #206891 |
ORIG-1 |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
ACELLA |
|
Approval |
06/09/2017 |
SPRITAM NDA #207958 |
SUPPL-4 |
LEVETIRACETAM |
APRECIA PHARMS |
Labeling |
Approval |
06/09/2017 |
PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #209008 |
ORIG-1 |
PSEUDOEPHEDRINE HYDROCHLORIDE |
AUROBINDO PHARMA |
|
Approval |
06/09/2017 |
AMANTADINE HYDROCHLORIDE ANDA #209035 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
06/12/2017 |
BUPROPION HYDROCHLORIDE ANDA #077285 |
SUPPL-34 |
BUPROPION HYDROCHLORIDE |
WATSON LABS INC |
Labeling |
Approval |
06/12/2017 |
EZETIMIBE ANDA #078724 |
ORIG-1 |
EZETIMIBE |
TEVA PHARMS USA |
|
Approval |
06/12/2017 |
BUPROPION HYDROCHLORIDE ANDA #090325 |
SUPPL-13 |
BUPROPION HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
06/12/2017 |
BUPROPION HYDROCHLORIDE ANDA #090942 |
SUPPL-12 |
BUPROPION HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
06/12/2017 |
BUPROPION HYDROCHLORIDE ANDA #090942 |
SUPPL-13 |
BUPROPION HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
06/12/2017 |
INTRON A BLA #103132 |
SUPPL-5195 |
INTERFERON ALFA-2B |
SCHERING |
|
Approval |
06/12/2017 |
EZETIMIBE ANDA #200831 |
ORIG-1 |
EZETIMIBE |
WATSON LABS INC |
|
Approval |
06/12/2017 |
ADVIL NDA #201803 |
SUPPL-8 |
IBUPROFEN SODIUM |
HALEON US HOLDINGS |
Labeling |
Approval |
06/12/2017 |
LEVETIRACETAM IN SODIUM CHLORIDE NDA #202543 |
SUPPL-10 |
LEVETIRACETAM |
HQ SPCLT PHARMA |
Labeling |
Approval |
06/12/2017 |
EZETIMIBE ANDA #203931 |
ORIG-1 |
EZETIMIBE |
SANDOZ |
|
Approval |
06/12/2017 |
OXYCODONE HYDROCHLORIDE ANDA #204021 |
ORIG-1 |
OXYCODONE HYDROCHLORIDE |
NOVEL LABS INC |
|
Approval |
06/12/2017 |
EZETIMIBE ANDA #204331 |
ORIG-1 |
EZETIMIBE |
ZYDUS PHARMS |
|
Approval |
06/12/2017 |
BUPROPION HYDROCHLORIDE ANDA #206556 |
SUPPL-3 |
BUPROPION HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
06/12/2017 |
BENDAMUSTINE HYDROCHLORIDE ANDA #207149 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
WOCKHARDT USA |
|
Tentative Approval |
06/12/2017 |
EZETIMIBE ANDA #207311 |
ORIG-1 |
EZETIMIBE |
OHM LABS INC |
|
Approval |
06/12/2017 |
EZETIMIBE ANDA #208332 |
ORIG-1 |
EZETIMIBE |
APOTEX |
|
Approval |
06/12/2017 |
ITRACONAZOLE ANDA #208591 |
ORIG-1 |
ITRACONAZOLE |
ALKEM LABS LTD |
|
Approval |
06/12/2017 |
EZETIMIBE ANDA #208803 |
ORIG-1 |
EZETIMIBE |
AMNEAL PHARMS CO |
|
Approval |
06/12/2017 |
AMANTADINE HYDROCHLORIDE ANDA #209171 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
HERITAGE PHARMA |
|
Approval |
06/13/2017 |
VERMOX NDA #017481 |
SUPPL-47 |
MEBENDAZOLE |
JANSSEN PHARMS |
Labeling |
Approval |
06/13/2017 |
SULAR NDA #020356 |
SUPPL-27 |
NISOLDIPINE |
COVIS |
Labeling |
Approval |
06/13/2017 |
ZIDOVUDINE ANDA #077981 |
SUPPL-24 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
06/13/2017 |
ZIDOVUDINE ANDA #077981 |
SUPPL-25 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
06/13/2017 |
OMEPRAZOLE ANDA #204661 |
ORIG-1 |
OMEPRAZOLE |
TEVA PHARMS USA |
|
Approval |
06/13/2017 |
INCRUSE ELLIPTA NDA #205382 |
SUPPL-6 |
UMECLIDINIUM BROMIDE |
GLAXO GRP ENGLAND |
Labeling |
Approval |
06/13/2017 |
ACYCLOVIR SODIUM ANDA #206606 |
ORIG-1 |
ACYCLOVIR SODIUM |
ZYDUS PHARMS |
|
Approval |
06/13/2017 |
SEVELAMER CARBONATE ANDA #207624 |
ORIG-1 |
SEVELAMER CARBONATE |
AUROBINDO PHARMA |
|
Approval |
06/14/2017 |
DYSPORT BLA #125274 |
SUPPL-109 |
abobotulinumtoxinA |
IPSEN BIOPHARM LTD |
|
Approval |
06/14/2017 |
CALCITRIOL ANDA #203289 |
ORIG-1 |
CALCITRIOL |
AMNEAL PHARMS |
|
Approval |
06/14/2017 |
PREZCOBIX NDA #205395 |
SUPPL-4 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
06/14/2017 |
DOXYCYCLINE HYCLATE ANDA #208765 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
DR REDDYS LABS SA |
|
Approval |
06/15/2017 |
ZOLOFT NDA #019839 |
SUPPL-88 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
06/15/2017 |
ZOLOFT NDA #020990 |
SUPPL-46 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
06/15/2017 |
KALETRA NDA #021226 |
SUPPL-45 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/15/2017 |
KALETRA NDA #021251 |
SUPPL-54 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/15/2017 |
VFEND NDA #021266 |
SUPPL-41 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
06/15/2017 |
VFEND NDA #021267 |
SUPPL-53 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
06/15/2017 |
VFEND NDA #021630 |
SUPPL-31 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
06/15/2017 |
KALETRA NDA #021906 |
SUPPL-49 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/15/2017 |
INVEGA SUSTENNA NDA #022264 |
SUPPL-23 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
06/15/2017 |
METAXALONE ANDA #203695 |
ORIG-1 |
METAXALONE |
ACTAVIS LABS FL INC |
|
Approval |
06/15/2017 |
AUROVELA 24 FE ANDA #207504 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
|
Approval |
06/15/2017 |
SYMJEPI NDA #207534 |
ORIG-1 |
EPINEPHRINE |
ADAMIS PHARMS CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/15/2017 |
AUROVELA FE 1.5/30 ANDA #207580 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
|
Approval |
06/15/2017 |
CALCIUM GLUCONATE NDA #208418 |
ORIG-1 |
CALCIUM GLUCONATE |
FRESENIUS KABI USA |
Type 7 - Drug Already Marketed without Approved NDA |
Approval |
06/15/2017 |
CALCIUM GLUCONATE IN SODIUM CHLORIDE NDA #208418 |
ORIG-1 |
CALCIUM GLUCONATE |
FRESENIUS KABI USA |
Type 7 - Drug Already Marketed without Approved NDA |
Approval |
06/15/2017 |
GLYCOPYRROLATE ANDA #208973 |
ORIG-1 |
GLYCOPYRROLATE |
AMNEAL |
|
Approval |
06/15/2017 |
AMANTADINE HYDROCHLORIDE ANDA #209221 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
|
Approval |
06/16/2017 |
ADDYI NDA #022526 |
SUPPL-4 |
FLIBANSERIN |
SPROUT PHARMS |
REMS |
Approval |
06/16/2017 |
SYNERCID NDA #050747 |
SUPPL-15 |
QUINUPRISTIN; DALFOPRISTIN |
KING PHARMS |
Labeling |
Approval |
06/16/2017 |
SYNERCID NDA #050748 |
SUPPL-14 |
DALFOPRISTIN; QUINUPRISTIN |
KING PHARMS |
Labeling |
Approval |
06/16/2017 |
PROPRANOLOL HYDROCHLORIDE ANDA #070690 |
SUPPL-21 |
PROPRANOLOL HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/16/2017 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #076914 |
SUPPL-4 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
GRAVITI PHARMS |
Labeling |
Approval |
06/16/2017 |
LAMOTRIGINE ANDA #078947 |
SUPPL-22 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
06/16/2017 |
LAMOTRIGINE ANDA #078947 |
SUPPL-23 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
06/16/2017 |
OXYCODONE AND ACETAMINOPHEN ANDA #201972 |
SUPPL-7 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
06/16/2017 |
SKLICE NDA #202736 |
SUPPL-3 |
IVERMECTIN |
ARBOR PHARMS LLC |
Labeling |
Approval |
06/16/2017 |
TAFINLAR NDA #202806 |
SUPPL-7 |
DABRAFENIB MESYLATE |
NOVARTIS |
Labeling |
Approval |
06/16/2017 |
DIFLUNISAL ANDA #203547 |
ORIG-1 |
DIFLUNISAL |
ZYDUS PHARMS |
|
Approval |
06/16/2017 |
NIACIN ANDA #203899 |
ORIG-1 |
NIACIN |
LANNETT CO INC |
|
Approval |
06/16/2017 |
NEURACEQ NDA #204677 |
SUPPL-14 |
FLORBETABEN F-18 |
LIFE MOLECULAR |
Labeling |
Approval |
06/16/2017 |
OLANZAPINE ANDA #204866 |
ORIG-1 |
OLANZAPINE |
HIKMA |
|
Approval |
06/16/2017 |
CISATRACURIUM BESYLATE PRESERVATIVE FREE ANDA #205872 |
ORIG-1 |
CISATRACURIUM BESYLATE |
ACCORD HLTHCARE |
|
Approval |
06/16/2017 |
CISATRACURIUM BESYLATE ANDA #205873 |
ORIG-1 |
CISATRACURIUM BESYLATE |
ACCORD HLTHCARE |
|
Approval |
06/16/2017 |
FELBAMATE ANDA #206314 |
ORIG-1 |
FELBAMATE |
TARO |
|
Approval |
06/16/2017 |
ORFADIN NDA #206356 |
SUPPL-4 |
NITISINONE |
SWEDISH ORPHAN |
Labeling |
Approval |
06/16/2017 |
ELETRIPTAN HYDROBROMIDE ANDA #206409 |
ORIG-1 |
ELETRIPTAN HYDROBROMIDE |
ZYDUS PHARMS |
|
Approval |
06/16/2017 |
XADAGO NDA #207145 |
SUPPL-1 |
SAFINAMIDE MESYLATE |
MDD US |
Labeling |
Approval |
06/16/2017 |
AUROVELA FE 1/20 ANDA #207505 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
|
Approval |
06/16/2017 |
AUROVELA 1/20 ANDA #207506 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
|
Approval |
06/16/2017 |
TESTOSTERONE CYPIONATE ANDA #207742 |
ORIG-1 |
TESTOSTERONE CYPIONATE |
AM REGENT |
|
Approval |
06/16/2017 |
HER STYLE ANDA #207976 |
SUPPL-1 |
LEVONORGESTREL |
NOVAST LABS |
Labeling |
Approval |
06/16/2017 |
HER STYLE ANDA #207976 |
SUPPL-2 |
LEVONORGESTREL |
NOVAST LABS |
Labeling |
Approval |
06/16/2017 |
LINAGLIPTIN ANDA #208415 |
ORIG-1 |
LINAGLIPTIN |
AUROBINDO PHARMA LTD |
|
Tentative Approval |
06/16/2017 |
DARZALEX BLA #761036 |
SUPPL-5 |
DARATUMUMAB |
JANSSEN BIOTECH |
|
Approval |
06/17/2017 |
ABSORICA NDA #021951 |
SUPPL-10 |
ISOTRETINOIN |
SUN PHARM INDS INC |
REMS |
Approval |
06/17/2017 |
AMNESTEEM ANDA #075945 |
SUPPL-34 |
ISOTRETINOIN |
MYLAN PHARMS INC |
REMS |
Approval |
06/17/2017 |
CLARAVIS ANDA #076135 |
SUPPL-38 |
ISOTRETINOIN |
TEVA PHARMS USA |
REMS |
Approval |
06/17/2017 |
CLARAVIS ANDA #076356 |
SUPPL-35 |
ISOTRETINOIN |
TEVA PHARMS USA |
REMS |
Approval |
06/17/2017 |
MYORISAN ANDA #076485 |
SUPPL-15 |
ISOTRETINOIN |
UPSHER SMITH LABS |
REMS |
Approval |
06/17/2017 |
ZENATANE ANDA #202099 |
SUPPL-9 |
ISOTRETINOIN |
DR REDDYS LABS LTD |
REMS |
Approval |
06/19/2017 |
PREZISTA NDA #021976 |
SUPPL-45 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
06/19/2017 |
TOTECT NDA #022025 |
SUPPL-15 |
DEXRAZOXANE HYDROCHLORIDE |
CLINIGEN |
Manufacturing (CMC) |
Approval |
06/19/2017 |
TACLONEX NDA #022185 |
SUPPL-25 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
LEO PHARMA AS |
Manufacturing (CMC) |
Approval |
06/19/2017 |
TACLONEX NDA #022185 |
SUPPL-25 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE |
LEO PHARMA AS |
Manufacturing (CMC) |
Approval |
06/19/2017 |
PREZISTA NDA #202895 |
SUPPL-20 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
06/19/2017 |
DANTROLENE SODIUM ANDA #204762 |
ORIG-1 |
DANTROLENE SODIUM |
HIKMA |
|
Approval |
06/19/2017 |
COTEMPLA XR-ODT NDA #205489 |
ORIG-1 |
METHYLPHENIDATE |
NEOS THERAPS INC |
Type 3 - New Dosage Form |
Approval |
06/19/2017 |
BAXDELA NDA #208610 |
ORIG-1 |
DELAFLOXACIN MEGLUMINE |
MELINTA |
Type 1 - New Molecular Entity |
Approval |
06/19/2017 |
BAXDELA NDA #208611 |
ORIG-1 |
DELAFLOXACIN MEGLUMINE |
MELINTA |
Type 3 - New Dosage Form |
Approval |
06/20/2017 |
MYDAYIS NDA #022063 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Type 3 - New Dosage Form |
Approval |
06/20/2017 |
ACETAZOLAMIDE SODIUM ANDA #205358 |
ORIG-1 |
ACETAZOLAMIDE SODIUM |
ENDO OPERATIONS |
|
Approval |
06/20/2017 |
PIROXICAM ANDA #206136 |
ORIG-1 |
PIROXICAM |
STRIDES PHARMA |
|
Approval |
06/20/2017 |
LIDOCAINE ANDA #206297 |
SUPPL-2 |
LIDOCAINE |
AMNEAL PHARMS |
Labeling |
Approval |
06/20/2017 |
LIDOCAINE ANDA #206297 |
SUPPL-3 |
LIDOCAINE |
AMNEAL PHARMS |
Manufacturing (CMC) |
Approval |
06/20/2017 |
LIDOCAINE ANDA #206297 |
SUPPL-5 |
LIDOCAINE |
AMNEAL PHARMS |
Manufacturing (CMC) |
Approval |
06/20/2017 |
PAROXETINE MESYLATE ANDA #207139 |
ORIG-1 |
PAROXETINE MESYLATE |
ACTAVIS LABS FL INC |
|
Approval |
06/20/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207171 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
LANNETT CO INC |
|
Approval |
06/20/2017 |
METRONIDAZOLE ANDA #208681 |
ORIG-1 |
METRONIDAZOLE |
ALEMBIC |
|
Approval |
06/20/2017 |
CANDESARTAN CILEXETIL ANDA #209119 |
ORIG-1 |
CANDESARTAN CILEXETIL |
ALEMBIC |
|
Approval |
06/21/2017 |
DARAPRIM NDA #008578 |
SUPPL-20 |
PYRIMETHAMINE |
TILDE SCIENCES |
Labeling |
Approval |
06/21/2017 |
CHILDREN'S ADVIL NDA #020589 |
SUPPL-35 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
06/21/2017 |
CHILDREN'S ADVIL-FLAVORED NDA #020589 |
SUPPL-35 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
06/21/2017 |
ESTRACE ANDA #086069 |
SUPPL-23 |
ESTRADIOL |
ALLERGAN |
Labeling |
Approval |
06/21/2017 |
GRANIX BLA #125294 |
SUPPL-42 |
TBO-FILGRASTIM |
SICOR BIOTECH |
|
Approval |
06/21/2017 |
SYNRIBO NDA #203585 |
SUPPL-5 |
OMACETAXINE MEPESUCCINATE |
TEVA PHARMS INTL |
Labeling |
Approval |
06/21/2017 |
IMATINIB MESYLATE ANDA #204644 |
ORIG-1 |
IMATINIB MESYLATE |
MYLAN |
|
Approval |
06/21/2017 |
AMANTADINE HYDROCHLORIDE ANDA #208966 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
ALEMBIC |
|
Approval |
06/21/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209036 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
ABHAI LLC |
|
Approval |
06/21/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209037 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
ABHAI LLC |
|
Approval |
06/22/2017 |
PRIMAQUINE NDA #008316 |
SUPPL-23 |
PRIMAQUINE PHOSPHATE |
SANOFI AVENTIS US |
Labeling |
Approval |
06/22/2017 |
VALCYTE NDA #021304 |
SUPPL-12 |
VALGANCICLOVIR HYDROCHLORIDE |
CHEPLAPHARM |
Labeling |
Approval |
06/22/2017 |
VALCYTE NDA #022257 |
SUPPL-7 |
VALGANCICLOVIR HYDROCHLORIDE |
CHEPLAPHARM |
Labeling |
Approval |
06/22/2017 |
QUETIAPINE FUMARATE ANDA #077745 |
SUPPL-9 |
QUETIAPINE FUMARATE |
TEVA PHARMS |
Labeling |
Approval |
06/22/2017 |
QUETIAPINE FUMARATE ANDA #077745 |
SUPPL-10 |
QUETIAPINE FUMARATE |
TEVA PHARMS |
Labeling |
Approval |
06/22/2017 |
QUETIAPINE FUMARATE ANDA #090749 |
SUPPL-5 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
06/22/2017 |
QUETIAPINE FUMARATE ANDA #090749 |
SUPPL-6 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
06/22/2017 |
QUETIAPINE FUMARATE ANDA #090960 |
SUPPL-8 |
QUETIAPINE FUMARATE |
ZENNOVA |
Labeling |
Approval |
06/22/2017 |
QUETIAPINE FUMARATE ANDA #090960 |
SUPPL-9 |
QUETIAPINE FUMARATE |
ZENNOVA |
Labeling |
Approval |
06/22/2017 |
SIMPONI BLA #125289 |
SUPPL-133 |
GOLIMUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
06/22/2017 |
TAFINLAR NDA #202806 |
SUPPL-6 |
DABRAFENIB MESYLATE |
NOVARTIS |
Efficacy |
Approval |
06/22/2017 |
INDOMETHACIN ANDA #203501 |
ORIG-1 |
INDOMETHACIN |
GLENMARK PHARMS LTD |
|
Approval |
06/22/2017 |
MEKINIST NDA #204114 |
SUPPL-5 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Efficacy |
Approval |
06/22/2017 |
ATRACURIUM BESYLATE ANDA #206096 |
ORIG-1 |
ATRACURIUM BESYLATE |
NORVIUM BIOSCIENCE |
|
Approval |
06/22/2017 |
MORPHINE SULFATE ANDA #206308 |
ORIG-1 |
MORPHINE SULFATE |
RHODES PHARMS |
|
Approval |
06/22/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #207172 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
LANNETT CO INC |
|
Approval |
06/22/2017 |
METHOCARBAMOL ANDA #207496 |
ORIG-1 |
METHOCARBAMOL |
AM REGENT |
|
Approval |
06/22/2017 |
AMANTADINE HYDROCHLORIDE ANDA #208107 |
SUPPL-2 |
AMANTADINE HYDROCHLORIDE |
WATSON LABS INC |
Manufacturing (CMC) |
Approval |
06/22/2017 |
RITUXAN HYCELA BLA #761064 |
ORIG-1 |
RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
GENENTECH INC |
|
Approval |
06/22/2017 |
RITUXAN HYCELA BLA #761064 |
SUPPL-1 |
RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
GENENTECH INC |
|
Approval |
06/23/2017 |
ANECTINE NDA #008453 |
SUPPL-33 |
SUCCINYLCHOLINE CHLORIDE |
SANDOZ |
Manufacturing (CMC) |
Approval |
06/23/2017 |
LIPITOR NDA #020702 |
SUPPL-67 |
ATORVASTATIN CALCIUM |
UPJOHN |
Efficacy |
Approval |
06/23/2017 |
LIPITOR NDA #020702 |
SUPPL-69 |
ATORVASTATIN CALCIUM |
UPJOHN |
Labeling |
Approval |
06/23/2017 |
AEROSPAN HFA NDA #021247 |
SUPPL-15 |
FLUNISOLIDE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
06/23/2017 |
CADUET NDA #021540 |
SUPPL-39 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
PHARMACIA |
Labeling |
Approval |
06/23/2017 |
ENTECAVIR ANDA #206745 |
ORIG-1 |
ENTECAVIR |
ZYDUS PHARMS |
|
Approval |
06/23/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #206869 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
AMNEAL PHARMS NY |
|
Approval |
06/23/2017 |
AZACITIDINE ANDA #207234 |
ORIG-1 |
AZACITIDINE |
NATCO PHARMA LTD |
|
Approval |
06/23/2017 |
GLYCOPYRROLATE ANDA #207639 |
ORIG-1 |
GLYCOPYRROLATE |
SOMERSET THERAPS LLC |
|
Approval |
06/23/2017 |
BEVYXXA NDA #208383 |
ORIG-1 |
BETRIXABAN |
PORTOLA PHARMS INC |
Type 1 - New Molecular Entity |
Approval |
06/23/2017 |
IBUPROFEN ANDA #209204 |
ORIG-1 |
IBUPROFEN |
TARO |
|
Approval |
06/26/2017 |
OXYBUTYNIN CHLORIDE ANDA #202332 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
ZYDUS PHARMS |
|
Approval |
06/26/2017 |
PANTOPRAZOLE SODIUM ANDA #202882 |
SUPPL-7 |
PANTOPRAZOLE SODIUM |
HETERO LABS LTD V |
Labeling |
Approval |
06/26/2017 |
TAMSULOSIN HYDROCHLORIDE ANDA #204645 |
SUPPL-1 |
TAMSULOSIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Manufacturing (CMC) |
Approval |
06/26/2017 |
AUROVELA 1.5/30 ANDA #207581 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AUROBINDO PHARMA |
|
Approval |
06/27/2017 |
THALOMID NDA #020785 |
SUPPL-63 |
THALIDOMIDE |
BRISTOL-MYERS |
REMS |
Approval |
06/27/2017 |
REVLIMID NDA #021880 |
SUPPL-50 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
REMS |
Approval |
06/27/2017 |
DULERA NDA #022518 |
SUPPL-21 |
FORMOTEROL FUMARATE; MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
06/27/2017 |
OCTREOTIDE ACETATE ANDA #075957 |
SUPPL-25 |
OCTREOTIDE ACETATE |
MEITHEAL |
Labeling |
Approval |
06/27/2017 |
OCTREOTIDE ACETATE ANDA #075959 |
SUPPL-26 |
OCTREOTIDE ACETATE |
MEITHEAL |
Labeling |
Approval |
06/27/2017 |
METHADONE HYDROCHLORIDE INTENSOL ANDA #089897 |
SUPPL-36 |
METHADONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
06/27/2017 |
ELETRIPTAN HYDROBROMIDE ANDA #202040 |
ORIG-1 |
ELETRIPTAN HYDROBROMIDE |
TEVA PHARMS USA |
|
Approval |
06/27/2017 |
POMALYST NDA #204026 |
SUPPL-16 |
POMALIDOMIDE |
BRISTOL |
REMS |
Approval |
06/27/2017 |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ANDA #204087 |
ORIG-1 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
ENCUBE |
|
Approval |
06/27/2017 |
TRANEXAMIC ACID ANDA #206713 |
ORIG-1 |
TRANEXAMIC ACID |
MICRO LABS |
|
Approval |
06/27/2017 |
DEXTROAMPHETAMINE SULFATE ANDA #209111 |
ORIG-1 |
DEXTROAMPHETAMINE SULFATE |
NESHER PHARMS |
|
Approval |
06/27/2017 |
IBUPROFEN ANDA #209207 |
ORIG-1 |
IBUPROFEN |
TARO |
|
Approval |
06/28/2017 |
XARELTO NDA #022406 |
SUPPL-23 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
06/28/2017 |
AZITHROMYCIN ANDA #065246 |
SUPPL-19 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
06/28/2017 |
AZITHROMYCIN ANDA #065246 |
SUPPL-22 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
06/28/2017 |
AZITHROMYCIN ANDA #065246 |
SUPPL-23 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
06/28/2017 |
AZITHROMYCIN ANDA #065246 |
SUPPL-24 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
06/28/2017 |
OCTREOTIDE ACETATE ANDA #077372 |
SUPPL-10 |
OCTREOTIDE ACETATE |
SUN PHARM INDS |
Labeling |
Approval |
06/28/2017 |
OCTREOTIDE ACETATE ANDA #077373 |
SUPPL-8 |
OCTREOTIDE ACETATE |
SUN PHARM INDS |
Labeling |
Approval |
06/28/2017 |
ZIDOVUDINE ANDA #078349 |
SUPPL-20 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
06/28/2017 |
ZIDOVUDINE ANDA #078349 |
SUPPL-21 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
06/28/2017 |
HYDROCORTISONE ANDA #083365 |
SUPPL-41 |
HYDROCORTISONE |
HIKMA INTL PHARMS |
Labeling |
Approval |
06/28/2017 |
HYDROCORTISONE ANDA #083365 |
SUPPL-43 |
HYDROCORTISONE |
HIKMA INTL PHARMS |
Labeling |
Approval |
06/28/2017 |
HYDROCORTISONE ANDA #083365 |
SUPPL-45 |
HYDROCORTISONE |
HIKMA INTL PHARMS |
Labeling |
Approval |
06/28/2017 |
HYDROCORTISONE ANDA #083365 |
SUPPL-46 |
HYDROCORTISONE |
HIKMA INTL PHARMS |
Labeling |
Approval |
06/28/2017 |
OLOPATADINE HYDROCHLORIDE ANDA #200810 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
GLENMARK PHARMS INC |
|
Approval |
06/28/2017 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-1 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
06/28/2017 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-4 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
06/28/2017 |
LO MINASTRIN FE NDA #204654 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
APIL |
Labeling |
Approval |
06/28/2017 |
PHENTERMINE HYDROCHLORIDE ANDA #204663 |
ORIG-1 |
PHENTERMINE HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
06/28/2017 |
TELMISARTAN ANDA #205150 |
SUPPL-3 |
TELMISARTAN |
INVENTIA |
Manufacturing (CMC) |
Approval |
06/28/2017 |
TOBRAMYCIN ANDA #207444 |
ORIG-1 |
TOBRAMYCIN |
SOMERSET THERAPS LLC |
|
Approval |
06/28/2017 |
DOXEPIN HYDROCHLORIDE ANDA #207482 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
AMNEAL PHARMS CO |
|
Approval |
06/28/2017 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER ANDA #208084 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
BAXTER HLTHCARE CORP |
|
Approval |
06/29/2017 |
NORVIR NDA #020659 |
SUPPL-66 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/29/2017 |
NORVIR NDA #020945 |
SUPPL-44 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/29/2017 |
NORVIR NDA #022417 |
SUPPL-18 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/29/2017 |
OXYCODONE AND ASPIRIN ANDA #040255 |
SUPPL-26 |
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE |
ANI PHARMS |
Labeling |
Approval |
06/29/2017 |
CLOZAPINE ANDA #075713 |
SUPPL-38 |
CLOZAPINE |
SUN PHARM INDS INC |
Labeling |
Approval |
06/29/2017 |
CLOZAPINE ANDA #075713 |
SUPPL-39 |
CLOZAPINE |
SUN PHARM INDS INC |
Labeling |
Approval |
06/29/2017 |
CLOZAPINE ANDA #075713 |
SUPPL-41 |
CLOZAPINE |
SUN PHARM INDS INC |
Labeling |
Approval |
06/29/2017 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #077184 |
SUPPL-13 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
06/29/2017 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #078778 |
SUPPL-5 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
06/29/2017 |
IMIPRAMINE HYDROCHLORIDE ANDA #087846 |
SUPPL-29 |
IMIPRAMINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
06/29/2017 |
TOFRANIL ANDA #087846 |
SUPPL-29 |
IMIPRAMINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
06/29/2017 |
VECTIBIX BLA #125147 |
SUPPL-207 |
PANITUMUMAB |
AMGEN |
|
Approval |
06/29/2017 |
OXYCODONE HYDROCHLORIDE ANDA #203107 |
SUPPL-1 |
OXYCODONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
06/29/2017 |
OTEZLA NDA #205437 |
SUPPL-6 |
APREMILAST |
AMGEN INC |
Labeling |
Approval |
06/29/2017 |
LONSURF NDA #207981 |
SUPPL-6 |
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE |
TAIHO ONCOLOGY |
Labeling |
Approval |
06/29/2017 |
TRIPTODUR KIT NDA #208956 |
ORIG-1 |
TRIPTORELIN PAMOATE |
AZURITY |
Type 5 - New Formulation or New Manufacturer |
Approval |
06/29/2017 |
NORVIR NDA #209512 |
SUPPL-1 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
06/30/2017 |
DESYREL NDA #018207 |
SUPPL-32 |
TRAZODONE HYDROCHLORIDE |
PRAGMA |
Labeling |
Approval |
06/30/2017 |
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BK 0/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-18 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #075914 |
SUPPL-29 |
BUPROPION HYDROCHLORIDE |
IMPAX LABS |
Labeling |
Approval |
06/30/2017 |
LEFLUNOMIDE ANDA #077090 |
SUPPL-13 |
LEFLUNOMIDE |
APOTEX INC |
Labeling |
Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #077475 |
SUPPL-18 |
BUPROPION HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #077475 |
SUPPL-19 |
BUPROPION HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
06/30/2017 |
PRAVASTATIN SODIUM ANDA #077987 |
SUPPL-13 |
PRAVASTATIN SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #079094 |
SUPPL-24 |
BUPROPION HYDROCHLORIDE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
06/30/2017 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #090080 |
ORIG-1 |
MOXIFLOXACIN HYDROCHLORIDE |
APOTEX |
|
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #090120 |
SUPPL-6 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #090120 |
SUPPL-7 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
06/30/2017 |
ACTIVASE BLA #103172 |
SUPPL-5253 |
ALTEPLASE |
GENENTECH |
|
Approval |
06/30/2017 |
CATHFLO ACTIVASE BLA #103172 |
SUPPL-5253 |
ALTEPLASE |
GENENTECH |
|
Approval |
06/30/2017 |
ORENCIA BLA #125118 |
SUPPL-209 |
ABATACEPT |
BRISTOL MYERS SQUIBB |
|
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #201109 |
SUPPL-8 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #201109 |
SUPPL-10 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #202152 |
SUPPL-9 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #202152 |
SUPPL-10 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #203359 |
SUPPL-2 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #203359 |
SUPPL-3 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #203390 |
SUPPL-1 |
QUETIAPINE FUMARATE |
ALEMBIC |
Labeling |
Approval |
06/30/2017 |
QUETIAPINE FUMARATE ANDA #203390 |
SUPPL-2 |
QUETIAPINE FUMARATE |
ALEMBIC |
Labeling |
Approval |
06/30/2017 |
EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE NDA #204119 |
ORIG-1 |
EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
HETERO DRUGS LTD |
Type 4 - New Combination |
Tentative Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #206122 |
SUPPL-1 |
BUPROPION HYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
06/30/2017 |
ZOLMITRIPTAN ANDA #206973 |
ORIG-1 |
ZOLMITRIPTAN |
APPCO |
|
Approval |
06/30/2017 |
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER NDA #207026 |
SUPPL-4 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER NDA #207026 |
SUPPL-4 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #207224 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
ANBISON LAB |
|
Approval |
06/30/2017 |
BUPROPION HYDROCHLORIDE ANDA #207459 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
JUBILANT GENERICS |
|
Approval |
06/30/2017 |
ANAGRELIDE HYDROCHLORIDE ANDA #209151 |
ORIG-1 |
ANAGRELIDE HYDROCHLORIDE |
TORRENT |
|
Approval |
06/30/2017 |
PROMETHAZINE HYDROCHLORIDE ANDA #209177 |
ORIG-1 |
PROMETHAZINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
06/30/2017 |
PANTOPRAZOLE SODIUM NDA #209463 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
HIKMA |
Type 5 - New Formulation or New Manufacturer |
Approval |