04/01/2018 |
LINCOCIN NDA #050317 |
SUPPL-184 |
LINCOMYCIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
04/02/2018 |
ULTRAVIST 150 NDA #020220 |
SUPPL-45 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/02/2018 |
ULTRAVIST 240 NDA #020220 |
SUPPL-45 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/02/2018 |
ULTRAVIST 300 NDA #020220 |
SUPPL-45 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/02/2018 |
ULTRAVIST 300 IN PLASTIC CONTAINER NDA #020220 |
SUPPL-45 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/02/2018 |
ULTRAVIST 370 NDA #020220 |
SUPPL-45 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/02/2018 |
ULTRAVIST (PHARMACY BULK) NDA #021425 |
SUPPL-28 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/02/2018 |
XYZAL NDA #022064 |
SUPPL-36 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
04/02/2018 |
XYZAL NDA #022157 |
SUPPL-18 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
04/02/2018 |
BYDUREON NDA #022200 |
SUPPL-26 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Efficacy |
Approval |
04/02/2018 |
BYDUREON PEN NDA #022200 |
SUPPL-26 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Efficacy |
Approval |
04/02/2018 |
AMLODIPINE BESYLATE ANDA #076719 |
SUPPL-11 |
AMLODIPINE BESYLATE |
COREPHARMA |
Labeling |
Approval |
04/02/2018 |
AMLODIPINE BESYLATE ANDA #077262 |
SUPPL-6 |
AMLODIPINE BESYLATE |
HIKMA |
Labeling |
Approval |
04/02/2018 |
AMLODIPINE BESYLATE ANDA #078414 |
SUPPL-13 |
AMLODIPINE BESYLATE |
OXFORD PHARMS |
Labeling |
Approval |
04/02/2018 |
AMLODIPINE BESYLATE ANDA #202553 |
SUPPL-1 |
AMLODIPINE BESYLATE |
ACCORD HLTHCARE |
Labeling |
Approval |
04/02/2018 |
AMLODIPINE BESYLATE ANDA #202553 |
SUPPL-2 |
AMLODIPINE BESYLATE |
ACCORD HLTHCARE |
Labeling |
Approval |
04/02/2018 |
STRIVERDI RESPIMAT NDA #203108 |
SUPPL-6 |
OLODATEROL HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
04/03/2018 |
FLAGYL NDA #012623 |
SUPPL-67 |
METRONIDAZOLE |
PFIZER |
Labeling |
Approval |
04/03/2018 |
METRONIDAZOLE IN PLASTIC CONTAINER NDA #018890 |
SUPPL-52 |
METRONIDAZOLE |
HOSPIRA |
Labeling |
Approval |
04/03/2018 |
FLAGYL NDA #020334 |
SUPPL-10 |
METRONIDAZOLE |
PFIZER |
Labeling |
Approval |
04/03/2018 |
FLAGYL ER NDA #020868 |
SUPPL-12 |
METRONIDAZOLE |
PFIZER |
Labeling |
Approval |
04/03/2018 |
PRILOSEC OTC NDA #021229 |
SUPPL-31 |
OMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
Labeling |
Approval |
04/03/2018 |
EMEND NDA #022023 |
SUPPL-17 |
FOSAPREPITANT DIMEGLUMINE |
MERCK AND CO INC |
Efficacy |
Approval |
04/03/2018 |
BESIVANCE NDA #022308 |
SUPPL-13 |
BESIFLOXACIN HYDROCHLORIDE |
BAUSCH AND LOMB |
Labeling |
Approval |
04/03/2018 |
AMLODIPINE BESYLATE ANDA #076418 |
SUPPL-20 |
AMLODIPINE BESYLATE |
MYLAN |
Labeling |
Approval |
04/03/2018 |
AMLODIPINE BESYLATE ANDA #077974 |
SUPPL-4 |
AMLODIPINE BESYLATE |
SUN PHARM INDS LTD |
Labeling |
Approval |
04/03/2018 |
AMLODIPINE BESYLATE ANDA #077974 |
SUPPL-5 |
AMLODIPINE BESYLATE |
SUN PHARM INDS LTD |
Labeling |
Approval |
04/03/2018 |
RITUXAN BLA #103705 |
SUPPL-5453 |
RITUXIMAB |
GENENTECH |
|
Approval |
04/03/2018 |
AMLODIPINE BESYLATE ANDA #201380 |
SUPPL-7 |
AMLODIPINE BESYLATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
04/04/2018 |
TAMIFLU NDA #021087 |
SUPPL-69 |
OSELTAMIVIR PHOSPHATE |
ROCHE |
Labeling |
Approval |
04/04/2018 |
TAMIFLU NDA #021246 |
SUPPL-52 |
OSELTAMIVIR PHOSPHATE |
ROCHE |
Labeling |
Approval |
04/04/2018 |
ACITRETIN ANDA #091455 |
SUPPL-12 |
ACITRETIN |
BARR LABS INC |
Labeling |
Approval |
04/04/2018 |
ACITRETIN ANDA #202897 |
SUPPL-12 |
ACITRETIN |
TEVA PHARMS USA |
Labeling |
Approval |
04/04/2018 |
ROCURONIUM BROMIDE ANDA #205656 |
ORIG-1 |
ROCURONIUM BROMIDE |
GLAND PHARMA LTD |
|
Approval |
04/04/2018 |
TESTOSTERONE CYPIONATE ANDA #207742 |
SUPPL-1 |
TESTOSTERONE CYPIONATE |
AM REGENT |
Manufacturing (CMC) |
Approval |
04/05/2018 |
FEMARA NDA #020726 |
SUPPL-35 |
LETROZOLE |
NOVARTIS PHARMS |
Labeling |
Approval |
04/05/2018 |
NALLPEN IN PLASTIC CONTAINER NDA #050655 |
SUPPL-26 |
NAFCILLIN SODIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
04/05/2018 |
AMLODIPINE BESYLATE ANDA #078477 |
SUPPL-19 |
AMLODIPINE BESYLATE |
AMNEAL PHARMS NY |
Labeling |
Approval |
04/05/2018 |
CICLOPIROX ANDA #209975 |
ORIG-1 |
CICLOPIROX |
ENCUBE |
|
Approval |
04/06/2018 |
OFIRMEV NDA #022450 |
SUPPL-11 |
ACETAMINOPHEN |
MALLINCKRODT HOSP |
Labeling |
Approval |
04/06/2018 |
EXPAREL NDA #022496 |
SUPPL-9 |
BUPIVACAINE |
PACIRA PHARMS INC |
Efficacy |
Approval |
04/06/2018 |
ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040419 |
SUPPL-21 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
SPECGX LLC |
Labeling |
Approval |
04/06/2018 |
ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #040419 |
SUPPL-23 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
SPECGX LLC |
Labeling |
Approval |
04/06/2018 |
IBANDRONATE SODIUM ANDA #202671 |
SUPPL-2 |
IBANDRONATE SODIUM |
MYLAN LABS LTD |
Manufacturing (CMC) |
Approval |
04/06/2018 |
IBANDRONATE SODIUM ANDA #202671 |
SUPPL-4 |
IBANDRONATE SODIUM |
MYLAN LABS LTD |
Labeling |
Approval |
04/06/2018 |
PALIPERIDONE ANDA #205618 |
ORIG-1 |
PALIPERIDONE |
SUN PHARM |
|
Approval |
04/06/2018 |
ACYCLOVIR ANDA #209000 |
ORIG-1 |
ACYCLOVIR |
ALEMBIC |
|
Approval |
04/06/2018 |
RUBRACA NDA #209115 |
SUPPL-3 |
RUCAPARIB CAMSYLATE |
ZR PHARMA |
Efficacy |
Approval |
04/09/2018 |
PFIZERPEN ANDA #060657 |
SUPPL-28 |
PENICILLIN G POTASSIUM |
PFIZER |
Labeling |
Approval |
04/09/2018 |
CEFPROZIL ANDA #065208 |
SUPPL-7 |
CEFPROZIL |
TEVA |
Labeling |
Approval |
04/09/2018 |
CEFPROZIL ANDA #065261 |
SUPPL-15 |
CEFPROZIL |
LUPIN |
Labeling |
Approval |
04/09/2018 |
CEFPROZIL ANDA #065267 |
SUPPL-7 |
CEFPROZIL |
ORCHID HLTHCARE |
Labeling |
Approval |
04/09/2018 |
CEFPROZIL ANDA #065276 |
SUPPL-9 |
CEFPROZIL |
LUPIN |
Labeling |
Approval |
04/09/2018 |
CEFPROZIL ANDA #065284 |
SUPPL-12 |
CEFPROZIL |
ORCHID HLTHCARE |
Labeling |
Approval |
04/09/2018 |
CLOZAPINE ANDA #090308 |
ORIG-2 |
CLOZAPINE |
BARR LABS INC |
|
Approval |
04/09/2018 |
VALSARTAN ANDA #205347 |
ORIG-1 |
VALSARTAN |
SQUARE PHARMS |
|
Approval |
04/09/2018 |
LIDOCAINE ANDA #206297 |
SUPPL-7 |
LIDOCAINE |
AMNEAL PHARMS |
Labeling |
Approval |
04/09/2018 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE ANDA #206436 |
ORIG-1 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MYLAN |
|
Approval |
04/09/2018 |
AZITHROMYCIN ANDA #207531 |
ORIG-1 |
AZITHROMYCIN |
EPIC PHARMA LLC |
|
Approval |
04/09/2018 |
POLYETHYLENE GLYCOL 3350 ANDA #209017 |
ORIG-1 |
POLYETHYLENE GLYCOL 3350 |
AUROBINDO PHARMA LTD |
|
Approval |
04/09/2018 |
NITROGEN, NF NDA #211737 |
ORIG-1 |
NITROGEN |
CRISTAL ASU LLC |
Medical Gas |
Approval |
04/09/2018 |
MYLOTARG BLA #761060 |
SUPPL-1 |
GEMTUZUMAB OZOGAMICIN |
WYETH PHARMS INC |
|
Approval |
04/10/2018 |
CELESTONE SOLUSPAN NDA #014602 |
SUPPL-62 |
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE |
ORGANON |
Labeling |
Approval |
04/10/2018 |
AFINITOR NDA #022334 |
SUPPL-40 |
EVEROLIMUS |
NOVARTIS |
Efficacy |
Approval |
04/10/2018 |
BLINCYTO BLA #125557 |
SUPPL-14 |
BLINATUMOMAB |
AMGEN |
|
Approval |
04/10/2018 |
AFINITOR DISPERZ NDA #203985 |
SUPPL-13 |
EVEROLIMUS |
NOVARTIS PHARM |
Efficacy |
Approval |
04/10/2018 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ANDA #205078 |
ORIG-1 |
METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE |
SUN PHARMA GLOBAL |
|
Tentative Approval |
04/10/2018 |
LAMIVUDINE AND ZIDOVUDINE ANDA #206375 |
ORIG-1 |
LAMIVUDINE; ZIDOVUDINE |
ANDA REPOSITORY |
|
Approval |
04/10/2018 |
DOFETILIDE ANDA #208625 |
ORIG-1 |
DOFETILIDE |
BIONPHARMA |
|
Approval |
04/10/2018 |
DUPIXENT BLA #761055 |
SUPPL-3 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
04/11/2018 |
METRO I.V. IN PLASTIC CONTAINER NDA #018900 |
SUPPL-35 |
METRONIDAZOLE |
B BRAUN |
Labeling |
Approval |
04/11/2018 |
SEMPREX-D NDA #019806 |
SUPPL-13 |
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE |
AUXILIUM PHARMS LLC |
Labeling |
Approval |
04/11/2018 |
IBUPROFEN ANDA #079174 |
SUPPL-10 |
IBUPROFEN |
GRANULES INDIA |
Manufacturing (CMC) |
Approval |
04/11/2018 |
IBUPROFEN ANDA #079174 |
SUPPL-14 |
IBUPROFEN |
GRANULES INDIA |
Labeling |
Approval |
04/11/2018 |
DOCETAXEL NDA #203551 |
SUPPL-5 |
DOCETAXEL |
ACTAVIS |
Labeling |
Approval |
04/11/2018 |
DAPTOMYCIN ANDA #206077 |
ORIG-1 |
DAPTOMYCIN |
FRESENIUS KABI USA |
|
Approval |
04/11/2018 |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE ANDA #207455 |
ORIG-1 |
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE |
PRINSTON INC |
|
Approval |
04/11/2018 |
DOPAMINE HYDROCHLORIDE ANDA #207707 |
ORIG-1 |
DOPAMINE HYDROCHLORIDE |
HIKMA INTL PHARMS |
|
Approval |
04/11/2018 |
LORATADINE ANDA #208477 |
ORIG-1 |
LORATADINE |
AUROBINDO PHARMA LTD |
|
Approval |
04/11/2018 |
CYPROHEPTADINE HYDROCHLORIDE ANDA #209172 |
ORIG-1 |
CYPROHEPTADINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
04/11/2018 |
FLAC ANDA #210736 |
ORIG-1 |
FLUOCINOLONE ACETONIDE |
PATRIN |
|
Approval |
04/12/2018 |
RISPERDAL CONSTA NDA #021346 |
SUPPL-59 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
04/12/2018 |
ADVIL NDA #201803 |
SUPPL-11 |
IBUPROFEN SODIUM |
HALEON US HOLDINGS |
Labeling |
Approval |
04/12/2018 |
SYNDROS NDA #205525 |
SUPPL-5 |
DRONABINOL |
BENUVIA OPERATIONS |
Labeling |
Approval |
04/12/2018 |
EVEROLIMUS ANDA #206133 |
ORIG-1 |
EVEROLIMUS |
HIKMA |
|
Approval |
04/12/2018 |
NETSPOT NDA #208547 |
SUPPL-11 |
GALLIUM DOTATATE GA-68 |
AAA USA INC |
Labeling |
Approval |
04/12/2018 |
PRAXBIND BLA #761025 |
SUPPL-2 |
IDARUCIZUMAB |
BOEHRINGER INGELHEIM |
|
Approval |
04/13/2018 |
ANTIVERT NDA #010721 |
SUPPL-61 |
MECLIZINE HYDROCHLORIDE |
CASPER PHARMA LLC |
Efficacy |
Approval |
04/13/2018 |
PREVACID NDA #020406 |
SUPPL-84 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
04/13/2018 |
DEFINITY NDA #021064 |
SUPPL-21 |
PERFLUTREN |
LANTHEUS MEDCL |
Manufacturing (CMC) |
Approval |
04/13/2018 |
DEFINITY RT NDA #021064 |
SUPPL-21 |
PERFLUTREN |
LANTHEUS MEDCL |
Manufacturing (CMC) |
Approval |
04/13/2018 |
PREVACID NDA #021428 |
SUPPL-32 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
04/13/2018 |
NULOJIX BLA #125288 |
SUPPL-75 |
BELATACEPT |
BRISTOL MYERS SQUIBB |
|
Approval |
04/13/2018 |
VARUBI NDA #206500 |
SUPPL-3 |
ROLAPITANT HYDROCHLORIDE |
TERSERA |
Labeling |
Approval |
04/13/2018 |
VIBERZI NDA #206940 |
SUPPL-3 |
ELUXADOLINE |
ABBVIE |
Labeling |
Approval |
04/13/2018 |
VARUBI NDA #208399 |
SUPPL-2 |
ROLAPITANT HYDROCHLORIDE |
TERSERA |
Labeling |
Approval |
04/13/2018 |
PRAVASTATIN SODIUM ANDA #209869 |
ORIG-1 |
PRAVASTATIN SODIUM |
BIOCON PHARMA |
|
Approval |
04/13/2018 |
KEVZARA BLA #761037 |
SUPPL-1 |
SARILUMAB |
SANOFI SYNTHELABO |
|
Approval |
04/16/2018 |
TAZORAC NDA #020600 |
SUPPL-10 |
TAZAROTENE |
ALLERGAN |
Labeling |
Approval |
04/16/2018 |
TYGACIL NDA #021821 |
SUPPL-45 |
TIGECYCLINE |
PF PRISM CV |
Labeling |
Approval |
04/16/2018 |
CLEOCIN PHOSPHATE NDA #050441 |
SUPPL-79 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
04/16/2018 |
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #050639 |
SUPPL-38 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090108 |
SUPPL-5 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090108 |
SUPPL-6 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090108 |
SUPPL-9 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090108 |
SUPPL-10 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090109 |
SUPPL-7 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090109 |
SUPPL-8 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090109 |
SUPPL-11 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
CLINDAMYCIN PHOSPHATE ANDA #090109 |
SUPPL-12 |
CLINDAMYCIN PHOSPHATE |
SAGENT PHARMS INC |
Labeling |
Approval |
04/16/2018 |
YERVOY BLA #125377 |
SUPPL-94 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
04/16/2018 |
OPDIVO BLA #125554 |
SUPPL-58 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
04/16/2018 |
ADENOSINE ANDA #205568 |
ORIG-1 |
ADENOSINE |
FRESENIUS KABI USA |
|
Approval |
04/16/2018 |
LORATADINE ANDA #208314 |
ORIG-1 |
LORATADINE |
AUROBINDO PHARMA LTD |
|
Approval |
04/16/2018 |
ERTAPENEM SODIUM ANDA #208790 |
ORIG-1 |
ERTAPENEM SODIUM |
ACS DOBFAR SPA |
|
Approval |
04/16/2018 |
LORATADINE ANDA #210088 |
ORIG-1 |
LORATADINE |
SUN PHARM |
|
Approval |
04/16/2018 |
TACROLIMUS ANDA #210393 |
ORIG-1 |
TACROLIMUS |
GLENMARK PHARMS LTD |
|
Approval |
04/17/2018 |
CARNITOR NDA #018948 |
SUPPL-28 |
LEVOCARNITINE |
LEADIANT BIOSCI INC |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 12 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 140 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 180 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 210 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 240 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 300 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 350 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 70 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
OMNIPAQUE 9 NDA #018956 |
SUPPL-101 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
04/17/2018 |
CARNITOR NDA #019257 |
SUPPL-14 |
LEVOCARNITINE |
LEADIANT BIOSCI INC |
Labeling |
Approval |
04/17/2018 |
CARNITOR SF NDA #019257 |
SUPPL-14 |
LEVOCARNITINE |
LEADIANT BIOSCI INC |
Labeling |
Approval |
04/17/2018 |
CARNITOR NDA #020182 |
SUPPL-15 |
LEVOCARNITINE |
LEADIANT BIOSCI INC |
Labeling |
Approval |
04/17/2018 |
ALIMTA NDA #021462 |
SUPPL-52 |
PEMETREXED DISODIUM |
LILLY |
Labeling |
Approval |
04/17/2018 |
EVOCLIN NDA #050801 |
SUPPL-18 |
CLINDAMYCIN PHOSPHATE |
MYLAN |
Labeling |
Approval |
04/17/2018 |
IRBESARTAN ANDA #204740 |
ORIG-1 |
IRBESARTAN |
AMNEAL PHARMS |
|
Approval |
04/17/2018 |
MORPHINE SULFATE ANDA #205509 |
ORIG-1 |
MORPHINE SULFATE |
ANI PHARMS |
|
Approval |
04/17/2018 |
DICLOFENAC SODIUM ANDA #206411 |
ORIG-1 |
DICLOFENAC SODIUM |
ZYDUS LIFESCIENCES |
|
Approval |
04/17/2018 |
TRANYLCYPROMINE SULFATE ANDA #206856 |
ORIG-1 |
TRANYLCYPROMINE SULFATE |
NOVITIUM PHARMA |
|
Approval |
04/17/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #207806 |
ORIG-1 |
PIOGLITAZONE HYDROCHLORIDE |
PRINSTON INC |
|
Approval |
04/17/2018 |
MIGLUSTAT ANDA #208342 |
ORIG-1 |
MIGLUSTAT |
ANI PHARMS |
|
Approval |
04/17/2018 |
DOXAZOSIN MESYLATE ANDA #209013 |
ORIG-1 |
DOXAZOSIN MESYLATE |
UPSHER SMITH LABS |
|
Approval |
04/17/2018 |
IBUPROFEN ANDA #209179 |
ORIG-1 |
IBUPROFEN |
AUROBINDO PHARMA LTD |
|
Approval |
04/17/2018 |
TAVALISSE NDA #209299 |
ORIG-1 |
FOSTAMATINIB DISODIUM |
RIGEL PHARMS INC |
Type 1 - New Molecular Entity |
Approval |
04/17/2018 |
METHOCARBAMOL ANDA #209331 |
ORIG-1 |
METHOCARBAMOL |
FRESENIUS KABI USA |
|
Approval |
04/17/2018 |
CLOBETASOL PROPIONATE ANDA #209701 |
ORIG-1 |
CLOBETASOL PROPIONATE |
XIROMED |
|
Approval |
04/17/2018 |
CLOBETASOL PROPIONATE ANDA #209974 |
ORIG-1 |
CLOBETASOL PROPIONATE |
PAI HOLDINGS PHARM |
|
Approval |
04/17/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #210375 |
SUPPL-2 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
DR REDDYS |
Manufacturing (CMC) |
Approval |
04/17/2018 |
CLOBETASOL PROPIONATE ANDA #210446 |
ORIG-1 |
CLOBETASOL PROPIONATE |
APOTEX |
|
Approval |
04/17/2018 |
CAPECITABINE ANDA #210604 |
ORIG-1 |
CAPECITABINE |
EUGIA PHARMA |
|
Approval |
04/17/2018 |
SODIUM NITROPRUSSIDE ANDA #210763 |
ORIG-1 |
SODIUM NITROPRUSSIDE |
MYLAN LABS LTD |
|
Approval |
04/17/2018 |
CRYSVITA BLA #761068 |
ORIG-1 |
BUROSUMAB-TWZA |
KYOWA KIRIN |
|
Approval |
04/18/2018 |
LUPRON DEPOT NDA #020708 |
SUPPL-35 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
04/18/2018 |
GLUCAGEN NDA #020918 |
SUPPL-49 |
GLUCAGON HYDROCHLORIDE |
NOVO NORDISK |
Labeling |
Approval |
04/18/2018 |
GLUCAGON NDA #020928 |
SUPPL-55 |
GLUCAGON |
LILLY |
Labeling |
Approval |
04/18/2018 |
ADVIL PM NDA #021394 |
SUPPL-25 |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
04/18/2018 |
REYATAZ NDA #021567 |
SUPPL-42 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
04/18/2018 |
ASACOL HD NDA #021830 |
SUPPL-12 |
MESALAMINE |
ABBVIE |
Labeling |
Approval |
04/18/2018 |
CLARITIN NDA #021952 |
SUPPL-14 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
04/18/2018 |
TYSABRI BLA #125104 |
SUPPL-960 |
NATALIZUMAB |
BIOGEN IDEC |
|
Approval |
04/18/2018 |
TYSABRI BLA #125104 |
SUPPL-963 |
NATALIZUMAB |
BIOGEN IDEC |
|
Approval |
04/18/2018 |
TREPROSTINIL ANDA #203649 |
SUPPL-1 |
TREPROSTINIL |
SANDOZ |
Manufacturing (CMC) |
Approval |
04/18/2018 |
REYATAZ NDA #206352 |
SUPPL-7 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
04/18/2018 |
EVOTAZ NDA #206353 |
SUPPL-5 |
ATAZANAVIR SULFATE; COBICISTAT |
BRISTOL |
Labeling |
Approval |
04/18/2018 |
ARIPIPRAZOLE ANDA #207240 |
ORIG-1 |
ARIPIPRAZOLE |
SCIEGEN PHARMS INC |
|
Approval |
04/18/2018 |
LIDOCAINE HYDROCHLORIDE ANDA #208017 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
SPECTRA MDCL DEVICES |
|
Approval |
04/18/2018 |
TAGRISSO NDA #208065 |
SUPPL-8 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Efficacy |
Approval |
04/18/2018 |
TAGRISSO NDA #208065 |
SUPPL-9 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Labeling |
Approval |
04/18/2018 |
CLOBETASOL PROPIONATE ANDA #210190 |
ORIG-1 |
CLOBETASOL PROPIONATE |
GLENMARK PHARMS LTD |
|
Approval |
04/18/2018 |
ECONAZOLE NITRATE ANDA #210364 |
ORIG-1 |
ECONAZOLE NITRATE |
AUROBINDO PHARMA USA |
|
Approval |
04/19/2018 |
HIBISTAT NDA #018300 |
SUPPL-19 |
CHLORHEXIDINE GLUCONATE |
MOLNLYCKE HLTH |
Labeling |
Approval |
04/19/2018 |
THALITONE NDA #019574 |
SUPPL-16 |
CHLORTHALIDONE |
CASPER PHARMA LLC |
Labeling |
Approval |
04/19/2018 |
LEVULAN NDA #020965 |
SUPPL-16 |
AMINOLEVULINIC ACID HYDROCHLORIDE |
DUSA |
Labeling |
Approval |
04/19/2018 |
CLARINEX-D 12 HOUR NDA #021313 |
SUPPL-10 |
DESLORATADINE; PSEUDOEPHEDRINE SULFATE |
ORGANON LLC |
Labeling |
Approval |
04/19/2018 |
CLARINEX D 24 HOUR NDA #021605 |
SUPPL-13 |
DESLORATADINE; PSEUDOEPHEDRINE SULFATE |
ORGANON |
Labeling |
Approval |
04/19/2018 |
UNASYN NDA #050608 |
SUPPL-46 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
PFIZER |
Labeling |
Approval |
04/19/2018 |
LAMIVUDINE ANDA #090457 |
ORIG-1 |
LAMIVUDINE |
STRIDES PHARMA |
|
Approval |
04/19/2018 |
ACITRETIN ANDA #091455 |
SUPPL-10 |
ACITRETIN |
BARR LABS INC |
Labeling |
Approval |
04/19/2018 |
TALTZ BLA #125521 |
SUPPL-2 |
IXEKIZUMAB |
ELI LILLY AND CO |
|
Approval |
04/19/2018 |
ACITRETIN ANDA #202552 |
SUPPL-4 |
ACITRETIN |
IMPAX LABS INC |
Labeling |
Approval |
04/19/2018 |
ACITRETIN ANDA #202897 |
SUPPL-10 |
ACITRETIN |
TEVA PHARMS USA |
Labeling |
Approval |
04/19/2018 |
ACITRETIN ANDA #204633 |
SUPPL-4 |
ACITRETIN |
SIGMAPHARM LABS LLC |
Labeling |
Approval |
04/19/2018 |
SOOLANTRA NDA #206255 |
SUPPL-4 |
IVERMECTIN |
GALDERMA LABS LP |
Labeling |
Approval |
04/19/2018 |
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE ANDA #207442 |
ORIG-1 |
DEXAMETHASONE SODIUM PHOSPHATE |
SOMERSET THERAPS LLC |
|
Approval |
04/19/2018 |
AKYNZEO NDA #210493 |
ORIG-1 |
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE |
HELSINN HLTHCARE |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Approval |
04/20/2018 |
FENOFIBRATE ANDA #076509 |
SUPPL-26 |
FENOFIBRATE |
IMPAX LABS |
Labeling |
Approval |
04/20/2018 |
AMLODIPINE BESYLATE ANDA #077073 |
SUPPL-15 |
AMLODIPINE BESYLATE |
CIPLA |
Labeling |
Approval |
04/20/2018 |
AMLODIPINE BESYLATE ANDA #077073 |
SUPPL-16 |
AMLODIPINE BESYLATE |
CIPLA |
Labeling |
Approval |
04/20/2018 |
AMLODIPINE BESYLATE ANDA #077955 |
SUPPL-14 |
AMLODIPINE BESYLATE |
INVAGEN PHARMS |
Labeling |
Approval |
04/20/2018 |
TAFINLAR NDA #202806 |
SUPPL-9 |
DABRAFENIB MESYLATE |
NOVARTIS |
Labeling |
Approval |
04/20/2018 |
BLEOMYCIN SULFATE ANDA #205030 |
ORIG-1 |
BLEOMYCIN SULFATE |
MEITHEAL |
|
Approval |
04/20/2018 |
FERRIPROX NDA #208030 |
SUPPL-2 |
DEFERIPRONE |
CHIESI |
Efficacy |
Approval |
04/20/2018 |
LINAGLIPTIN ANDA #208472 |
ORIG-1 |
LINAGLIPTIN |
PRINSTON PHARMA INC |
|
Tentative Approval |
04/20/2018 |
TETRABENAZINE ANDA #210544 |
ORIG-1 |
TETRABENAZINE |
CHARTWELL RX |
|
Approval |
04/23/2018 |
DECADRON NDA #011664 |
SUPPL-65 |
DEXAMETHASONE |
MERCK |
Labeling |
Approval |
04/23/2018 |
ABSORICA NDA #021951 |
SUPPL-12 |
ISOTRETINOIN |
SUN PHARM INDS INC |
REMS |
Approval |
04/23/2018 |
SAMSCA NDA #022275 |
SUPPL-16 |
TOLVAPTAN |
OTSUKA |
Labeling |
Approval |
04/23/2018 |
E.E.S. NDA #050207 |
SUPPL-74 |
ERYTHROMYCIN ETHYLSUCCINATE |
AZURITY |
Labeling |
Approval |
04/23/2018 |
ERYPED NDA #050207 |
SUPPL-74 |
ERYTHROMYCIN ETHYLSUCCINATE |
AZURITY |
Labeling |
Approval |
04/23/2018 |
ERYC NDA #050536 |
SUPPL-26 |
ERYTHROMYCIN |
DR REDDYS LABS SA |
Labeling |
Approval |
04/23/2018 |
ERYTHROCIN NDA #050609 |
SUPPL-39 |
ERYTHROMYCIN LACTOBIONATE |
HOSPIRA |
Labeling |
Approval |
04/23/2018 |
PCE NDA #050611 |
SUPPL-36 |
ERYTHROMYCIN |
AZURITY |
Labeling |
Approval |
04/23/2018 |
CLONAZEPAM ANDA #074979 |
SUPPL-25 |
CLONAZEPAM |
SANDOZ |
Manufacturing (CMC) |
Approval |
04/23/2018 |
ETOPOSIDE ANDA #075635 |
SUPPL-13 |
ETOPOSIDE |
MYLAN |
Labeling |
Approval |
04/23/2018 |
AMNESTEEM ANDA #075945 |
SUPPL-36 |
ISOTRETINOIN |
MYLAN PHARMS INC |
REMS |
Approval |
04/23/2018 |
CLARAVIS ANDA #076135 |
SUPPL-42 |
ISOTRETINOIN |
TEVA PHARMS USA |
REMS |
Approval |
04/23/2018 |
CLARAVIS ANDA #076356 |
SUPPL-39 |
ISOTRETINOIN |
TEVA PHARMS USA |
REMS |
Approval |
04/23/2018 |
MYORISAN ANDA #076485 |
SUPPL-19 |
ISOTRETINOIN |
UPSHER SMITH LABS |
REMS |
Approval |
04/23/2018 |
ONDANSETRON HYDROCHLORIDE ANDA #077009 |
SUPPL-11 |
ONDANSETRON HYDROCHLORIDE |
TARO |
Labeling |
Approval |
04/23/2018 |
AMLODIPINE BESYLATE ANDA #077516 |
SUPPL-4 |
AMLODIPINE BESYLATE |
STRIDES PHARMA |
Labeling |
Approval |
04/23/2018 |
GABAPENTIN ANDA #078787 |
SUPPL-16 |
GABAPENTIN |
AUROBINDO PHARMA |
Labeling |
Approval |
04/23/2018 |
GABAPENTIN ANDA #078787 |
SUPPL-17 |
GABAPENTIN |
AUROBINDO PHARMA |
Labeling |
Approval |
04/23/2018 |
GABAPENTIN ANDA #078787 |
SUPPL-20 |
GABAPENTIN |
AUROBINDO PHARMA |
Labeling |
Approval |
04/23/2018 |
GABAPENTIN ANDA #078787 |
SUPPL-22 |
GABAPENTIN |
AUROBINDO PHARMA |
Labeling |
Approval |
04/23/2018 |
GABAPENTIN ANDA #078787 |
SUPPL-25 |
GABAPENTIN |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
04/23/2018 |
AMLODIPINE BESYLATE ANDA #090752 |
SUPPL-3 |
AMLODIPINE BESYLATE |
CHINA RESOURCES |
Labeling |
Approval |
04/23/2018 |
AMLODIPINE BESYLATE ANDA #090752 |
SUPPL-4 |
AMLODIPINE BESYLATE |
CHINA RESOURCES |
Labeling |
Approval |
04/23/2018 |
ZENATANE ANDA #202099 |
SUPPL-12 |
ISOTRETINOIN |
DR REDDYS LABS LTD |
REMS |
Approval |
04/23/2018 |
JYNARQUE NDA #204441 |
ORIG-1 |
TOLVAPTAN |
OTSUKA |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
04/23/2018 |
AMLODIPINE BESYLATE ANDA #206367 |
SUPPL-3 |
AMLODIPINE BESYLATE |
INVAGEN PHARMS |
Labeling |
Approval |
04/23/2018 |
METHYLPREDNISOLONE ANDA #206751 |
ORIG-1 |
METHYLPREDNISOLONE |
ZYDUS PHARMS |
|
Approval |
04/23/2018 |
ISOTRETINOIN ANDA #207792 |
SUPPL-3 |
ISOTRETINOIN |
AMNEAL PHARMS NY |
REMS |
Approval |
04/23/2018 |
AMLODIPINE BESYLATE ANDA #207821 |
SUPPL-1 |
AMLODIPINE BESYLATE |
POLYGEN PHARMS |
Labeling |
Approval |
04/23/2018 |
AMLODIPINE BESYLATE ANDA #207821 |
SUPPL-2 |
AMLODIPINE BESYLATE |
POLYGEN PHARMS |
Labeling |
Approval |
04/23/2018 |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #208369 |
SUPPL-1 |
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
04/23/2018 |
FLUOCINONIDE ANDA #209118 |
ORIG-1 |
FLUOCINONIDE |
CHARTWELL RX |
|
Approval |
04/23/2018 |
FLUOCINONIDE ANDA #209283 |
ORIG-1 |
FLUOCINONIDE |
MACLEODS PHARMS LTD |
|
Approval |
04/23/2018 |
VIGABATRIN ANDA #209824 |
ORIG-1 |
VIGABATRIN |
TEVA PHARMS USA |
|
Approval |
04/23/2018 |
KISQALI FEMARA CO-PACK (COPACKAGED) NDA #209935 |
SUPPL-1 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
04/23/2018 |
HELIUM, USP NDA #211781 |
ORIG-1 |
HELIUM |
A-OX WELDING SUPPLY CO, INC. |
Medical Gas |
Approval |
04/24/2018 |
ULTRAVIST 150 NDA #020220 |
SUPPL-46 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/24/2018 |
ULTRAVIST 240 NDA #020220 |
SUPPL-46 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/24/2018 |
ULTRAVIST 300 NDA #020220 |
SUPPL-46 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/24/2018 |
ULTRAVIST 300 IN PLASTIC CONTAINER NDA #020220 |
SUPPL-46 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/24/2018 |
ULTRAVIST 370 NDA #020220 |
SUPPL-46 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
04/24/2018 |
PLAN B NDA #021045 |
SUPPL-17 |
LEVONORGESTREL |
FDN CONSUMER |
Labeling |
Approval |
04/24/2018 |
MIRALAX NDA #022015 |
SUPPL-29 |
POLYETHYLENE GLYCOL 3350 |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
04/24/2018 |
AFREZZA BLA #022472 |
SUPPL-17 |
INSULIN RECOMBINANT HUMAN |
MANNKIND |
|
Approval |
04/24/2018 |
RABEPRAZOLE SODIUM ANDA #208644 |
ORIG-1 |
RABEPRAZOLE SODIUM |
ALKEM LABS LTD |
|
Approval |
04/24/2018 |
TRELEGY ELLIPTA NDA #209482 |
SUPPL-1 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Efficacy |
Approval |
04/25/2018 |
COLESTID NDA #017563 |
SUPPL-24 |
COLESTIPOL HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
04/25/2018 |
FLAVORED COLESTID NDA #017563 |
SUPPL-24 |
COLESTIPOL HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
04/25/2018 |
LOPID NDA #018422 |
SUPPL-58 |
GEMFIBROZIL |
PFIZER PHARMS |
Labeling |
Approval |
04/25/2018 |
OLUX NDA #021142 |
SUPPL-22 |
CLOBETASOL PROPIONATE |
MYLAN |
Labeling |
Approval |
04/25/2018 |
AEROSPAN HFA NDA #021247 |
SUPPL-17 |
FLUNISOLIDE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
04/25/2018 |
AMLODIPINE BESYLATE ANDA #078453 |
SUPPL-5 |
AMLODIPINE BESYLATE |
ORBION PHARMS |
Labeling |
Approval |
04/25/2018 |
AMLODIPINE BESYLATE ANDA #078453 |
SUPPL-6 |
AMLODIPINE BESYLATE |
ORBION PHARMS |
Labeling |
Approval |
04/25/2018 |
VELPHORO NDA #205109 |
SUPPL-6 |
FERRIC OXYHYDROXIDE |
VIFOR FRESENIUS |
Labeling |
Approval |
04/25/2018 |
XTRELUS NDA #208085 |
ORIG-1 |
GUAIFENESIN; HYDROCODONE BITARTRATE |
ECI PHARMS LLC |
Type 3 - New Dosage Form and Type 4 - New Combination |
Approval |
04/26/2018 |
ACTHAR GEL NDA #008372 |
SUPPL-57 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
04/26/2018 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-57 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
04/26/2018 |
MAGNEVIST NDA #019596 |
SUPPL-63 |
GADOPENTETATE DIMEGLUMINE |
BAYER HLTHCARE |
Labeling |
Approval |
04/26/2018 |
OMNISCAN NDA #020123 |
SUPPL-46 |
GADODIAMIDE |
GE HEALTHCARE |
Labeling |
Approval |
04/26/2018 |
PROHANCE NDA #020131 |
SUPPL-28 |
GADOTERIDOL |
BRACCO |
Labeling |
Approval |
04/26/2018 |
OPTIMARK NDA #020937 |
SUPPL-27 |
GADOVERSETAMIDE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
04/26/2018 |
OPTIMARK NDA #020975 |
SUPPL-28 |
GADOVERSETAMIDE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
04/26/2018 |
OPTIMARK IN PLASTIC CONTAINER NDA #020976 |
SUPPL-29 |
GADOVERSETAMIDE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
04/26/2018 |
MAGNEVIST NDA #021037 |
SUPPL-36 |
GADOPENTETATE DIMEGLUMINE |
BAYER HLTHCARE |
Labeling |
Approval |
04/26/2018 |
MULTIHANCE NDA #021357 |
SUPPL-16 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Labeling |
Approval |
04/26/2018 |
MULTIHANCE NDA #021357 |
SUPPL-17 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Labeling |
Approval |
04/26/2018 |
MULTIHANCE MULTIPACK NDA #021358 |
SUPPL-15 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Labeling |
Approval |
04/26/2018 |
MULTIHANCE MULTIPACK NDA #021358 |
SUPPL-16 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Labeling |
Approval |
04/26/2018 |
PROHANCE MULTIPACK NDA #021489 |
SUPPL-6 |
GADOTERIDOL |
BRACCO |
Labeling |
Approval |
04/26/2018 |
AMITIZA NDA #021908 |
SUPPL-16 |
LUBIPROSTONE |
SUCAMPO PHARMA LLC |
Efficacy |
Approval |
04/26/2018 |
OMNISCAN NDA #022066 |
SUPPL-8 |
GADODIAMIDE |
GE HEALTHCARE |
Labeling |
Approval |
04/26/2018 |
EOVIST NDA #022090 |
SUPPL-14 |
GADOXETATE DISODIUM |
BAYER HLTHCARE |
Labeling |
Approval |
04/26/2018 |
AMLODIPINE BESYLATE ANDA #077759 |
SUPPL-10 |
AMLODIPINE BESYLATE |
AIPING PHARM INC |
Labeling |
Approval |
04/26/2018 |
AMLODIPINE BESYLATE ANDA #078552 |
SUPPL-10 |
AMLODIPINE BESYLATE |
EPIC PHARMA LLC |
Labeling |
Approval |
04/26/2018 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #090485 |
SUPPL-13 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
04/26/2018 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ANDA #090485 |
SUPPL-14 |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
04/26/2018 |
GADAVIST NDA #201277 |
SUPPL-13 |
GADOBUTROL |
BAYER HLTHCARE |
Labeling |
Approval |
04/26/2018 |
AMLODIPINE BESYLATE ANDA #203245 |
SUPPL-10 |
AMLODIPINE BESYLATE |
UNICHEM |
Labeling |
Approval |
04/26/2018 |
DOTAREM NDA #204781 |
SUPPL-8 |
GADOTERATE MEGLUMINE |
GUERBET |
Labeling |
Approval |
04/26/2018 |
TRANEXAMIC ACID ANDA #206713 |
SUPPL-1 |
TRANEXAMIC ACID |
MICRO LABS |
Labeling |
Approval |
04/27/2018 |
EPIVIR NDA #020564 |
SUPPL-38 |
LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
04/27/2018 |
EPIVIR NDA #020596 |
SUPPL-37 |
LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
04/27/2018 |
COMBIVIR NDA #020857 |
SUPPL-33 |
LAMIVUDINE; ZIDOVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
04/27/2018 |
TRIZIVIR NDA #021205 |
SUPPL-37 |
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
04/27/2018 |
EPZICOM NDA #021652 |
SUPPL-23 |
ABACAVIR SULFATE; LAMIVUDINE |
VIIV HLTHCARE |
Labeling |
Approval |
04/27/2018 |
EFAVIRENZ ANDA #078886 |
ORIG-1 |
EFAVIRENZ |
HETERO LABS LTD III |
|
Approval |
04/27/2018 |
HYDROMORPHONE HYDROCHLORIDE ANDA #202159 |
ORIG-1 |
HYDROMORPHONE HYDROCHLORIDE |
HIKMA |
|
Approval |
04/27/2018 |
MYRBETRIQ NDA #202611 |
SUPPL-11 |
MIRABEGRON |
APGDI |
Efficacy |
Approval |
04/27/2018 |
EXEMESTANE ANDA #210323 |
ORIG-1 |
EXEMESTANE |
CIPLA |
|
Approval |
04/27/2018 |
PHENYLEPHRINE HYDROCHLORIDE ANDA #210333 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
MEITHEAL |
|
Approval |
04/27/2018 |
PHENYLEPHRINE HYDROCHLORIDE ANDA #210334 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
MEITHEAL |
|
Approval |
04/30/2018 |
LITHOBID NDA #018027 |
SUPPL-64 |
LITHIUM CARBONATE |
ANI PHARMS |
Labeling |
Approval |
04/30/2018 |
MICRO-K NDA #018238 |
SUPPL-46 |
POTASSIUM CHLORIDE |
NESHER PHARMS |
Labeling |
Approval |
04/30/2018 |
MICRO-K 10 NDA #018238 |
SUPPL-46 |
POTASSIUM CHLORIDE |
NESHER PHARMS |
Labeling |
Approval |
04/30/2018 |
K-TAB NDA #018279 |
SUPPL-37 |
POTASSIUM CHLORIDE |
ABBVIE |
Labeling |
Approval |
04/30/2018 |
KLOR-CON NDA #019123 |
SUPPL-36 |
POTASSIUM CHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
04/30/2018 |
NAFTIN NDA #019356 |
SUPPL-8 |
NAFTIFINE HYDROCHLORIDE |
SEBELA IRELAND LTD |
Labeling |
Approval |
04/30/2018 |
NAFTIN NDA #019599 |
SUPPL-14 |
NAFTIFINE HYDROCHLORIDE |
SEBELA IRELAND LTD |
Labeling |
Approval |
04/30/2018 |
AVASTIN BLA #125085 |
SUPPL-324 |
BEVACIZUMAB |
GENENTECH |
|
Approval |
04/30/2018 |
TAFINLAR NDA #202806 |
SUPPL-8 |
DABRAFENIB MESYLATE |
NOVARTIS |
Efficacy |
Approval |
04/30/2018 |
BUMETANIDE ANDA #202900 |
ORIG-1 |
BUMETANIDE |
ZYDUS PHARMS |
|
Approval |
04/30/2018 |
MEKINIST NDA #204114 |
SUPPL-7 |
TRAMETINIB DIMETHYL SULFOXIDE |
NOVARTIS |
Efficacy |
Approval |
04/30/2018 |
NAFTIN NDA #204286 |
SUPPL-3 |
NAFTIFINE HYDROCHLORIDE |
SEBELA IRELAND LTD |
Labeling |
Approval |
04/30/2018 |
CELECOXIB ANDA #204776 |
ORIG-1 |
CELECOXIB |
MICRO LABS |
|
Approval |
04/30/2018 |
DOCETAXEL ANDA #208859 |
ORIG-1 |
DOCETAXEL |
MYLAN LABS LTD |
|
Approval |
04/30/2018 |
CINACALCET HYDROCHLORIDE ANDA #209226 |
ORIG-1 |
CINACALCET HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
04/30/2018 |
FENOFIBRATE (MICRONIZED) ANDA #209504 |
ORIG-1 |
FENOFIBRATE |
ANI PHARMS |
|
Approval |
04/30/2018 |
ESOMEPRAZOLE MAGNESIUM ANDA #209735 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
SUN PHARM |
|
Approval |
04/30/2018 |
NYSTATIN ANDA #210532 |
ORIG-1 |
NYSTATIN |
EPIC PHARMA LLC |
|
Approval |
04/30/2018 |
CLONIDINE HYDROCHLORIDE ANDA #210680 |
ORIG-1 |
CLONIDINE HYDROCHLORIDE |
DR REDDYS LABS SA |
|
Approval |
04/30/2018 |
OXYCODONE HYDROCHLORIDE ANDA #210758 |
ORIG-1 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
|
Approval |
04/30/2018 |
TECENTRIQ BLA #761034 |
SUPPL-3 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |