| 12/01/2017 |
HIPREX
NDA #017681 |
SUPPL-18 |
METHENAMINE HIPPURATE |
SS PHARMA |
Labeling |
Approval |
| 12/01/2017 |
LEXIVA
NDA #021548 |
SUPPL-40 |
FOSAMPRENAVIR CALCIUM |
VIIV HLTHCARE |
Labeling |
Approval |
| 12/01/2017 |
LEXIVA
NDA #022116 |
SUPPL-24 |
FOSAMPRENAVIR CALCIUM |
VIIV HLTHCARE |
Labeling |
Approval |
| 12/01/2017 |
MOZOBIL
NDA #022311 |
SUPPL-18 |
PLERIXAFOR |
GENZYME |
Labeling |
Approval |
| 12/01/2017 |
CILOSTAZOL
ANDA #077021 |
SUPPL-14 |
CILOSTAZOL |
CASI PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/01/2017 |
CILOSTAZOL
ANDA #077310 |
SUPPL-12 |
CILOSTAZOL |
CASI PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/01/2017 |
QUETIAPINE FUMARATE
ANDA #090757 |
ORIG-1 |
QUETIAPINE FUMARATE |
ANCHEN PHARMS |
|
Approval |
| 12/01/2017 |
TALTZ
BLA #125521 |
SUPPL-4 |
IXEKIZUMAB |
ELI LILLY AND CO |
|
Approval |
| 12/01/2017 |
REPATHA
BLA #125522 |
SUPPL-13 |
EVOLOCUMAB |
AMGEN INC |
|
Approval |
| 12/01/2017 |
REPATHA
BLA #125522 |
SUPPL-14 |
EVOLOCUMAB |
AMGEN INC |
|
Approval |
| 12/01/2017 |
MEGESTROL ACETATE
ANDA #204688 |
ORIG-1 |
MEGESTROL ACETATE |
CHARTWELL |
|
Approval |
| 12/01/2017 |
THIAMINE HYDROCHLORIDE
ANDA #206106 |
ORIG-1 |
THIAMINE HYDROCHLORIDE |
SAGENT PHARMS INC |
|
Approval |
| 12/01/2017 |
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #209235 |
ORIG-1 |
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
AUROBINDO PHARMA |
|
Approval |
| 12/01/2017 |
OGIVRI
BLA #761074 |
ORIG-1 |
TRASTUZUMAB-DKST |
MYLAN GMBH |
|
Approval |
| 12/04/2017 |
FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018657 |
SUPPL-36 |
METRONIDAZOLE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/04/2017 |
NUVARING
NDA #021187 |
SUPPL-34 |
ETHINYL ESTRADIOL; ETONOGESTREL |
ORGANON USA ORGANON |
Labeling |
Approval |
| 12/04/2017 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065446 |
SUPPL-3 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 12/04/2017 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065446 |
SUPPL-7 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 12/04/2017 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065446 |
SUPPL-10 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 12/04/2017 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065446 |
SUPPL-11 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 12/04/2017 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065446 |
SUPPL-13 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 12/04/2017 |
PIPERACILLIN AND TAZOBACTAM
ANDA #065446 |
SUPPL-14 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 12/04/2017 |
ARIPIPRAZOLE
ANDA #205363 |
ORIG-1 |
ARIPIPRAZOLE |
PRINSTON INC |
|
Approval |
| 12/05/2017 |
HALDOL
NDA #015923 |
SUPPL-92 |
HALOPERIDOL LACTATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/05/2017 |
HALDOL
NDA #018701 |
SUPPL-70 |
HALOPERIDOL DECANOATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/05/2017 |
LEVO-T
NDA #021342 |
SUPPL-23 |
LEVOTHYROXINE SODIUM |
CEDIPROF INC |
Labeling |
Approval |
| 12/05/2017 |
OLOPATADINE HYDROCHLORIDE
ANDA #090918 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
APOTEX |
|
Approval |
| 12/05/2017 |
AVASTIN
BLA #125085 |
SUPPL-319 |
BEVACIZUMAB |
GENENTECH |
|
Approval |
| 12/05/2017 |
OLOPATADINE HYDROCHLORIDE
ANDA #204723 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
SAPTALIS PHARMS |
|
Approval |
| 12/05/2017 |
OLOPATADINE HYDROCHLORIDE
ANDA #206087 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
BAUSCH AND LOMB INC |
|
Approval |
| 12/05/2017 |
LONHALA MAGNAIR KIT
NDA #208437 |
ORIG-1 |
GLYCOPYRROLATE |
SUMITOMO PHARMA AM |
Type 3 - New Dosage Form and Type 4 - New Combination |
Approval |
| 12/05/2017 |
GANZYK-RTU
NDA #209347 |
SUPPL-2 |
GANCICLOVIR |
EXELA PHARMA |
Manufacturing (CMC) |
Approval |
| 12/05/2017 |
OZEMPIC
NDA #209637 |
ORIG-1 |
SEMAGLUTIDE |
NOVO |
Type 1 - New Molecular Entity |
Approval |
| 12/06/2017 |
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679 |
SUPPL-108 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019367 |
SUPPL-30 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/06/2017 |
CAVERJECT
NDA #020379 |
SUPPL-31 |
ALPROSTADIL |
PFIZER |
Labeling |
Approval |
| 12/06/2017 |
CAVERJECT
NDA #020379 |
SUPPL-32 |
ALPROSTADIL |
PFIZER |
Labeling |
Approval |
| 12/06/2017 |
CAVERJECT
NDA #020379 |
SUPPL-34 |
ALPROSTADIL |
PFIZER |
Labeling |
Approval |
| 12/06/2017 |
PROTONIX
NDA #020987 |
SUPPL-52 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/06/2017 |
PROTONIX IV
NDA #020988 |
SUPPL-58 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/06/2017 |
PROTONIX
NDA #022020 |
SUPPL-14 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/06/2017 |
JAKAFI
NDA #202192 |
SUPPL-15 |
RUXOLITINIB PHOSPHATE |
INCYTE CORP |
Labeling |
Approval |
| 12/06/2017 |
LINEZOLID
ANDA #205154 |
ORIG-1 |
LINEZOLID |
MYLAN LABS LTD |
|
Approval |
| 12/06/2017 |
GEMCITABINE HYDROCHLORIDE
ANDA #205242 |
ORIG-1 |
GEMCITABINE HYDROCHLORIDE |
MYLAN LABS LTD |
|
Approval |
| 12/06/2017 |
MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #207350 |
ORIG-1 |
MAGNESIUM SULFATE |
HQ SPCLT PHARMA |
|
Approval |
| 12/06/2017 |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
ANDA #208518 |
ORIG-1 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
PAR PHARM INC |
|
Approval |
| 12/06/2017 |
CLOZAPINE
ANDA #209480 |
ORIG-1 |
CLOZAPINE |
ZYDUS PHARMS |
|
Approval |
| 12/06/2017 |
CLOFARABINE
ANDA #209775 |
ORIG-1 |
CLOFARABINE |
MSN |
|
Approval |
| 12/07/2017 |
BICILLIN C-R
NDA #050138 |
SUPPL-238 |
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
| 12/07/2017 |
BICILLIN C-R 900/300
NDA #050138 |
SUPPL-238 |
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
| 12/07/2017 |
BICILLIN L-A
NDA #050141 |
SUPPL-235 |
PENICILLIN G BENZATHINE |
KING PHARMS LLC |
Labeling |
Approval |
| 12/07/2017 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #205752 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
SPECTRUM PHARMS |
|
Tentative Approval |
| 12/08/2017 |
ZYRTEC ALLERGY
NDA #019835 |
SUPPL-39 |
CETIRIZINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 12/08/2017 |
ZYRTEC HIVES RELIEF
NDA #019835 |
SUPPL-39 |
CETIRIZINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 12/08/2017 |
ZOLOFT
NDA #019839 |
SUPPL-91 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
| 12/08/2017 |
ZOLOFT
NDA #019839 |
SUPPL-93 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
| 12/08/2017 |
ZOLOFT
NDA #020990 |
SUPPL-49 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
| 12/08/2017 |
ZOLOFT
NDA #020990 |
SUPPL-50 |
SERTRALINE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
| 12/08/2017 |
TRUVADA
NDA #021752 |
SUPPL-54 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD |
REMS |
Approval |
| 12/08/2017 |
TIROSINT
NDA #021924 |
SUPPL-13 |
LEVOTHYROXINE SODIUM |
IBSA |
Labeling |
Approval |
| 12/08/2017 |
PRANDIMET
NDA #022386 |
SUPPL-16 |
METFORMIN HYDROCHLORIDE; REPAGLINIDE |
NOVO NORDISK INC |
Labeling |
Approval |
| 12/08/2017 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894 |
SUPPL-2 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TEVA PHARMS USA |
REMS |
Approval |
| 12/08/2017 |
MELPHALAN HYDROCHLORIDE
ANDA #203655 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 12/08/2017 |
LEVOFLOXACIN
ANDA #204899 |
ORIG-1 |
LEVOFLOXACIN |
MYLAN LABS LTD |
|
Approval |
| 12/08/2017 |
HYDROCORTISONE BUTYRATE
ANDA #205134 |
ORIG-1 |
HYDROCORTISONE BUTYRATE |
ACTAVIS MID ATLANTIC |
|
Approval |
| 12/08/2017 |
BUSULFAN
ANDA #205139 |
ORIG-1 |
BUSULFAN |
ACTAVIS |
|
Approval |
| 12/08/2017 |
OMIDRIA
NDA #205388 |
SUPPL-6 |
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE |
RAYNER SURGICAL |
Efficacy |
Approval |
| 12/08/2017 |
GANCICLOVIR SODIUM
ANDA #207645 |
ORIG-1 |
GANCICLOVIR SODIUM |
PHARMASCIENCE INC |
|
Approval |
| 12/08/2017 |
DARIFENACIN HYDROBROMIDE
ANDA #207681 |
ORIG-1 |
DARIFENACIN HYDROBROMIDE |
ALEMBIC |
|
Approval |
| 12/08/2017 |
TIAGABINE HYDROCHLORIDE
ANDA #208181 |
ORIG-1 |
TIAGABINE HYDROCHLORIDE |
AMNEAL PHARMS CO |
|
Approval |
| 12/08/2017 |
ZOLEDRONIC ACID
ANDA #209125 |
ORIG-1 |
ZOLEDRONIC ACID |
EUGIA PHARMA |
|
Approval |
| 12/08/2017 |
SINUVA
NDA #209310 |
ORIG-1 |
MOMETASONE FUROATE |
INTERSECT ENT INC |
Type 3 - New Dosage Form |
Approval |
| 12/08/2017 |
SODIUM NITROPRUSSIDE
ANDA #209352 |
ORIG-1 |
SODIUM NITROPRUSSIDE |
MICRO LABS |
|
Approval |
| 12/08/2017 |
DEFERASIROX
ANDA #209426 |
ORIG-1 |
DEFERASIROX |
TORRENT PHARMS LTD |
|
Tentative Approval |
| 12/09/2017 |
NEULASTA
BLA #125031 |
SUPPL-189 |
PEGFILGRASTIM |
AMGEN |
|
Approval |
| 12/09/2017 |
NEULASTA
BLA #125031 |
SUPPL-191 |
PEGFILGRASTIM |
AMGEN |
|
Approval |
| 12/11/2017 |
NICORETTE
NDA #018612 |
SUPPL-79 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
| 12/11/2017 |
NICORETTE (MINT)
NDA #018612 |
SUPPL-79 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
| 12/11/2017 |
NICORETTE
NDA #020066 |
SUPPL-60 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
| 12/11/2017 |
NICORETTE (MINT)
NDA #020066 |
SUPPL-60 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
| 12/11/2017 |
MYALEPT
BLA #125390 |
SUPPL-12 |
METRELEPTIN |
AMRYT |
|
Approval |
| 12/11/2017 |
ARIPIPRAZOLE
ANDA #202547 |
ORIG-1 |
ARIPIPRAZOLE |
ORBION PHARMS |
|
Approval |
| 12/11/2017 |
TRIAMCINOLONE ACETONIDE
ANDA #207550 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
AMNEAL |
|
Approval |
| 12/11/2017 |
XEPI
NDA #208945 |
ORIG-1 |
OZENOXACIN |
FERRER INTERNACIONAL |
Type 1 - New Molecular Entity |
Approval |
| 12/11/2017 |
ADMELOG
BLA #209196 |
ORIG-1 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
| 12/11/2017 |
ADMELOG SOLOSTAR
BLA #209196 |
ORIG-1 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
| 12/11/2017 |
MAVYRET
NDA #209394 |
SUPPL-3 |
GLECAPREVIR; PIBRENTASVIR |
ABBVIE |
Labeling |
Approval |
| 12/12/2017 |
OPTIRAY 240
NDA #020923 |
SUPPL-21 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 12/12/2017 |
OPTIRAY 300
NDA #020923 |
SUPPL-21 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 12/12/2017 |
OPTIRAY 320
NDA #020923 |
SUPPL-21 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 12/12/2017 |
OPTIRAY 350
NDA #020923 |
SUPPL-21 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 12/12/2017 |
TANZEUM
BLA #125431 |
SUPPL-21 |
ALBIGLUTIDE |
GLAXOSMITHKLINE LLC |
|
Approval |
| 12/12/2017 |
TRULICITY
BLA #125469 |
SUPPL-21 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
| 12/12/2017 |
NUCALA
BLA #125526 |
SUPPL-4 |
MEPOLIZUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
| 12/12/2017 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202891 |
ORIG-1 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 12/12/2017 |
NITROFURANTOIN
ANDA #205005 |
ORIG-1 |
NITROFURANTOIN, MACROCRYSTALLINE |
ZYDUS PHARMS |
|
Approval |
| 12/12/2017 |
TYDEMY
ANDA #205948 |
ORIG-1 |
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM |
LUPIN LTD |
|
Approval |
| 12/12/2017 |
TOLTERODINE TARTRATE
ANDA #206419 |
ORIG-1 |
TOLTERODINE TARTRATE |
HETERO LABS LTD III |
|
Approval |
| 12/12/2017 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #206876 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 12/12/2017 |
XULTOPHY 100/3.6
BLA #208583 |
SUPPL-1 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
|
Approval |
| 12/12/2017 |
METRONIDAZOLE
ANDA #209794 |
ORIG-1 |
METRONIDAZOLE |
CADILA PHARMS LTD |
|
Approval |
| 12/13/2017 |
DILTIAZEM HYDROCHLORIDE
ANDA #074941 |
SUPPL-9 |
DILTIAZEM HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 12/13/2017 |
DILTIAZEM HYDROCHLORIDE
ANDA #075853 |
SUPPL-9 |
DILTIAZEM HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 12/13/2017 |
AMANTADINE HYDROCHLORIDE
ANDA #076186 |
SUPPL-22 |
AMANTADINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Manufacturing (CMC) |
Approval |
| 12/13/2017 |
CAMPATH
BLA #103948 |
SUPPL-5159 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 12/13/2017 |
LEMTRADA
BLA #103948 |
SUPPL-5159 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 12/13/2017 |
YERVOY
BLA #125377 |
SUPPL-91 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 12/13/2017 |
JARDIANCE
NDA #204629 |
SUPPL-16 |
EMPAGLIFLOZIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/13/2017 |
OFEV
NDA #205832 |
SUPPL-7 |
NINTEDANIB ESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/13/2017 |
GLYXAMBI
NDA #206073 |
SUPPL-12 |
EMPAGLIFLOZIN; LINAGLIPTIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/13/2017 |
SYNJARDY
NDA #206111 |
SUPPL-15 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/13/2017 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
|
Approval |
| 12/13/2017 |
SYNJARDY XR
NDA #208658 |
SUPPL-4 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/13/2017 |
IXIFI
BLA #761072 |
ORIG-1 |
INFLIXIMAB-QBTX |
PFIZER INC |
|
Approval |
| 12/14/2017 |
IMITREX
NDA #020080 |
SUPPL-50 |
SUMATRIPTAN SUCCINATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/14/2017 |
IMITREX STATDOSE
NDA #020080 |
SUPPL-50 |
SUMATRIPTAN SUCCINATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/14/2017 |
IMITREX
NDA #020132 |
SUPPL-29 |
SUMATRIPTAN SUCCINATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/14/2017 |
IMITREX
NDA #020626 |
SUPPL-27 |
SUMATRIPTAN |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/14/2017 |
VIAGRA
NDA #020895 |
SUPPL-48 |
SILDENAFIL CITRATE |
VIATRIS |
Labeling |
Approval |
| 12/14/2017 |
BENAZEPRIL HYDROCHLORIDE
ANDA #076344 |
SUPPL-17 |
BENAZEPRIL HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/14/2017 |
BENAZEPRIL HYDROCHLORIDE
ANDA #077128 |
SUPPL-14 |
BENAZEPRIL HYDROCHLORIDE |
COREPHARMA |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #077587 |
SUPPL-2 |
GALANTAMINE HYDROBROMIDE |
CHARTWELL RX |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #077590 |
SUPPL-11 |
GALANTAMINE HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #077603 |
SUPPL-2 |
GALANTAMINE HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #077781 |
SUPPL-5 |
GALANTAMINE HYDROBROMIDE |
APOTEX INC |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #078898 |
SUPPL-7 |
GALANTAMINE HYDROBROMIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #079028 |
SUPPL-10 |
GALANTAMINE HYDROBROMIDE |
WATSON LABS |
Labeling |
Approval |
| 12/14/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #090957 |
SUPPL-11 |
GALANTAMINE HYDROBROMIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/14/2017 |
HUMIRA
BLA #125057 |
SUPPL-403 |
ADALIMUMAB |
ABBVIE INC |
|
Approval |
| 12/14/2017 |
ZOLEDRONIC ACID
ANDA #200918 |
SUPPL-1 |
ZOLEDRONIC ACID |
EPIC PHARMA LLC |
Labeling |
Approval |
| 12/14/2017 |
BUPROPION HYDROCHLORIDE
ANDA #202304 |
SUPPL-4 |
BUPROPION HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 12/14/2017 |
BUPROPION HYDROCHLORIDE
ANDA #202304 |
SUPPL-9 |
BUPROPION HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 12/14/2017 |
BUPROPION HYDROCHLORIDE
ANDA #202304 |
SUPPL-10 |
BUPROPION HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 12/14/2017 |
XELJANZ
NDA #203214 |
SUPPL-17 |
TOFACITINIB CITRATE |
PF PRISM CV |
Efficacy |
Approval |
| 12/14/2017 |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #205131 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
|
Approval |
| 12/14/2017 |
CAFFEINE CITRATE
ANDA #207400 |
ORIG-1 |
CAFFEINE CITRATE |
MICRO LABS |
|
Approval |
| 12/14/2017 |
DROPERIDOL
ANDA #208197 |
ORIG-1 |
DROPERIDOL |
HIKMA |
|
Approval |
| 12/14/2017 |
XELJANZ XR
NDA #208246 |
SUPPL-3 |
TOFACITINIB CITRATE |
PFIZER |
Efficacy |
Approval |
| 12/14/2017 |
ALTAFLUOR BENOX
NDA #208582 |
ORIG-1 |
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM |
ALTAIRE PHARMS INC |
Type 4 - New Combination |
Approval |
| 12/14/2017 |
ESKATA
NDA #209305 |
ORIG-1 |
HYDROGEN PEROXIDE |
ACLARIS |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/14/2017 |
GOPRELTO
NDA #209963 |
ORIG-1 |
COCAINE HYDROCHLORIDE |
NODEN PHARMA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/15/2017 |
NEVANAC
NDA #021862 |
SUPPL-13 |
NEPAFENAC |
HARROW EYE |
Labeling |
Approval |
| 12/15/2017 |
TREANDA
NDA #022249 |
SUPPL-23 |
BENDAMUSTINE HYDROCHLORIDE |
CEPHALON |
Labeling |
Approval |
| 12/15/2017 |
GILENYA
NDA #022527 |
SUPPL-22 |
FINGOLIMOD HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 12/15/2017 |
DEXAMETHASONE
ANDA #040700 |
SUPPL-2 |
DEXAMETHASONE |
BAUSCH |
Manufacturing (CMC) |
Approval |
| 12/15/2017 |
EFAVIRENZ
ANDA #078064 |
ORIG-1 |
EFAVIRENZ |
AUROBINDO PHARMA |
|
Approval |
| 12/15/2017 |
TECFIDERA
NDA #204063 |
SUPPL-20 |
DIMETHYL FUMARATE |
BIOGEN INC |
Labeling |
Approval |
| 12/15/2017 |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #206218 |
ORIG-1 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
TARO |
|
Approval |
| 12/15/2017 |
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473 |
SUPPL-1 |
LINEZOLID |
HOSPIRA |
Labeling |
Approval |
| 12/15/2017 |
AZELASTINE HYDROCHLORIDE
ANDA #208199 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
AMNEAL |
|
Approval |
| 12/17/2017 |
XIIDRA
NDA #208073 |
SUPPL-2 |
LIFITEGRAST |
BAUSCH AND LOMB INC |
Labeling |
Approval |
| 12/17/2017 |
MEDICAL AIR, USP
NDA #211270 |
ORIG-1 |
MEDICAL AIR |
LINDE GAS PUERTO RICO INC |
Medical Gas |
Approval |
| 12/18/2017 |
CLOMID
NDA #016131 |
SUPPL-28 |
CLOMIPHENE CITRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 12/18/2017 |
DROXIA
NDA #016295 |
SUPPL-49 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 12/18/2017 |
DROXIA
NDA #016295 |
SUPPL-50 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 12/18/2017 |
HYDREA
NDA #016295 |
SUPPL-49 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 12/18/2017 |
HYDREA
NDA #016295 |
SUPPL-50 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 12/18/2017 |
XIFAXAN
NDA #021361 |
SUPPL-23 |
RIFAXIMIN |
SALIX PHARMS |
Labeling |
Approval |
| 12/18/2017 |
MAXITROL
NDA #050023 |
SUPPL-36 |
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
HARROW EYE |
Labeling |
Approval |
| 12/18/2017 |
MAXITROL
NDA #050065 |
SUPPL-64 |
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
SANDOZ |
Labeling |
Approval |
| 12/18/2017 |
CELLCEPT
NDA #050722 |
SUPPL-37 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
| 12/18/2017 |
CELLCEPT
NDA #050723 |
SUPPL-37 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
| 12/18/2017 |
CELLCEPT
NDA #050758 |
SUPPL-34 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ROCHE PALO |
Labeling |
Approval |
| 12/18/2017 |
CELLCEPT
NDA #050759 |
SUPPL-42 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
| 12/18/2017 |
VANCOCIN HYDROCHLORIDE
ANDA #060180 |
SUPPL-48 |
VANCOMYCIN HYDROCHLORIDE |
STERISCIENCE |
Labeling |
Approval |
| 12/18/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206245 |
SUPPL-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
NOVEL LABS INC |
Labeling |
Approval |
| 12/18/2017 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206245 |
SUPPL-3 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
NOVEL LABS INC |
Manufacturing (CMC) |
Approval |
| 12/18/2017 |
MESNA
ANDA #206992 |
ORIG-1 |
MESNA |
GLAND |
|
Approval |
| 12/18/2017 |
NEXIUM 24HR
NDA #207920 |
SUPPL-2 |
ESOMEPRAZOLE MAGNESIUM |
ASTRAZENECA LP |
Labeling |
Approval |
| 12/18/2017 |
RHOPRESSA
NDA #208254 |
ORIG-1 |
NETARSUDIL MESYLATE |
ALCON LABS INC |
Type 1 - New Molecular Entity |
Approval |
| 12/18/2017 |
TETRABENAZINE
ANDA #208826 |
ORIG-1 |
TETRABENAZINE |
BIONPHARMA |
|
Approval |
| 12/18/2017 |
BUSULFAN
ANDA #209580 |
ORIG-1 |
BUSULFAN |
AMNEAL |
|
Approval |
| 12/18/2017 |
SODIUM NITROPRUSSIDE
ANDA #209832 |
ORIG-1 |
SODIUM NITROPRUSSIDE |
AMPHASTAR PHARMS INC |
|
Approval |
| 12/19/2017 |
ZERIT
NDA #020412 |
SUPPL-40 |
STAVUDINE |
BRISTOL |
Labeling |
Approval |
| 12/19/2017 |
ZERIT
NDA #020413 |
SUPPL-32 |
STAVUDINE |
BRISTOL |
Labeling |
Approval |
| 12/19/2017 |
EFFEXOR XR
NDA #020699 |
SUPPL-110 |
VENLAFAXINE HYDROCHLORIDE |
UPJOHN |
Labeling |
Approval |
| 12/19/2017 |
EFFEXOR XR
NDA #020699 |
SUPPL-111 |
VENLAFAXINE HYDROCHLORIDE |
UPJOHN |
Labeling |
Approval |
| 12/19/2017 |
CYMBALTA
NDA #021427 |
SUPPL-50 |
DULOXETINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
| 12/19/2017 |
PRISTIQ
NDA #021992 |
SUPPL-46 |
DESVENLAFAXINE SUCCINATE |
PF PRISM CV |
Labeling |
Approval |
| 12/19/2017 |
VENLAFAXINE HYDROCHLORIDE
NDA #022104 |
SUPPL-16 |
VENLAFAXINE HYDROCHLORIDE |
OSMOTICA PHARM US |
Labeling |
Approval |
| 12/19/2017 |
SAVELLA
NDA #022256 |
SUPPL-23 |
MILNACIPRAN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
| 12/19/2017 |
CASPORYN HC
NDA #060613 |
SUPPL-13 |
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
CASPER PHARMA LLC |
Labeling |
Approval |
| 12/19/2017 |
AUBAGIO
NDA #202992 |
SUPPL-4 |
TERIFLUNOMIDE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 12/19/2017 |
BOSULIF
NDA #203341 |
SUPPL-9 |
BOSUTINIB MONOHYDRATE |
PF PRISM CV |
Efficacy |
Approval |
| 12/19/2017 |
DESVENLAFAXINE
NDA #204150 |
SUPPL-7 |
DESVENLAFAXINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 12/19/2017 |
FETZIMA
NDA #204168 |
SUPPL-5 |
LEVOMILNACIPRAN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
| 12/19/2017 |
BORTEZOMIB
ANDA #204332 |
ORIG-1 |
BORTEZOMIB |
ACTAVIS LLC |
|
Tentative Approval |
| 12/19/2017 |
KHEDEZLA
NDA #204683 |
SUPPL-5 |
DESVENLAFAXINE |
OSMOTICA PHARM CORP |
Labeling |
Approval |
| 12/19/2017 |
DESVENLAFAXINE
NDA #205583 |
SUPPL-6 |
DESVENLAFAXINE FUMARATE |
SUN PHARM |
Labeling |
Approval |
| 12/19/2017 |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #206180 |
ORIG-1 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
AUROBINDO PHARMA |
|
Approval |
| 12/19/2017 |
FENOFIBRATE
ANDA #207803 |
ORIG-1 |
FENOFIBRATE |
AUSTARPHARMA |
|
Approval |
| 12/19/2017 |
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
NDA #208083 |
SUPPL-1 |
CLINDAMYCIN PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/19/2017 |
CABOMETYX
NDA #208692 |
SUPPL-2 |
CABOZANTINIB S-MALATE |
EXELIXIS INC |
Efficacy |
Approval |
| 12/19/2017 |
PREXXARTAN
NDA #209139 |
ORIG-1 |
VALSARTAN |
CARMEL BIOSCIENCES |
Type 3 - New Dosage Form |
Approval |
| 12/19/2017 |
STEGLATRO
NDA #209803 |
ORIG-1 |
ERTUGLIFLOZIN |
MSD SUB MERCK |
Type 1 - New Molecular Entity |
Approval |
| 12/19/2017 |
STEGLUJAN
NDA #209805 |
ORIG-1 |
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Type 4 - New Combination |
Approval |
| 12/19/2017 |
SEGLUROMET
NDA #209806 |
ORIG-1 |
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE |
MSD SUB MERCK |
Type 4 - New Combination |
Approval |
| 12/19/2017 |
NIFEDIPINE
ANDA #210012 |
ORIG-1 |
NIFEDIPINE |
ZYDUS PHARMS |
|
Approval |
| 12/20/2017 |
ALBENZA
NDA #020666 |
SUPPL-10 |
ALBENDAZOLE |
IMPAX LABS INC |
Labeling |
Approval |
| 12/20/2017 |
PROTONIX
NDA #020987 |
SUPPL-51 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/20/2017 |
PROTONIX IV
NDA #020988 |
SUPPL-55 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/20/2017 |
ADVAIR DISKUS 100/50
NDA #021077 |
SUPPL-56 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Efficacy |
Approval |
| 12/20/2017 |
ADVAIR DISKUS 100/50
NDA #021077 |
SUPPL-57 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Efficacy |
Approval |
| 12/20/2017 |
ADVAIR DISKUS 250/50
NDA #021077 |
SUPPL-56 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Efficacy |
Approval |
| 12/20/2017 |
ADVAIR DISKUS 250/50
NDA #021077 |
SUPPL-57 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Efficacy |
Approval |
| 12/20/2017 |
ADVAIR DISKUS 500/50
NDA #021077 |
SUPPL-56 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Efficacy |
Approval |
| 12/20/2017 |
ADVAIR DISKUS 500/50
NDA #021077 |
SUPPL-57 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Efficacy |
Approval |
| 12/20/2017 |
ADVAIR HFA
NDA #021254 |
SUPPL-27 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 12/20/2017 |
SYMBICORT
NDA #021929 |
SUPPL-42 |
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE |
ASTRAZENECA |
Efficacy |
Approval |
| 12/20/2017 |
PROTONIX
NDA #022020 |
SUPPL-13 |
PANTOPRAZOLE SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/20/2017 |
INVEGA SUSTENNA
NDA #022264 |
SUPPL-15 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 12/20/2017 |
DULERA
NDA #022518 |
SUPPL-22 |
FORMOTEROL FUMARATE; MOMETASONE FUROATE |
ORGANON LLC |
Efficacy |
Approval |
| 12/20/2017 |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #085372 |
SUPPL-14 |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
LANNETT |
Manufacturing (CMC) |
Approval |
| 12/20/2017 |
PERJETA
BLA #125409 |
SUPPL-113 |
PERTUZUMAB |
GENENTECH |
|
Approval |
| 12/20/2017 |
PERJETA
BLA #125409 |
SUPPL-118 |
PERTUZUMAB |
GENENTECH |
|
Approval |
| 12/20/2017 |
TANZEUM
BLA #125431 |
SUPPL-20 |
ALBIGLUTIDE |
GLAXOSMITHKLINE LLC |
|
Approval |
| 12/20/2017 |
OPDIVO
BLA #125554 |
SUPPL-55 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 12/20/2017 |
ICLUSIG
NDA #203469 |
SUPPL-27 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/20/2017 |
ICLUSIG
NDA #203469 |
SUPPL-28 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/20/2017 |
BREO ELLIPTA
NDA #204275 |
SUPPL-15 |
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 12/20/2017 |
IMBRUVICA
NDA #205552 |
SUPPL-20 |
IBRUTINIB |
PHARMACYCLICS LLC |
Efficacy |
Approval |
| 12/20/2017 |
MACRILEN
NDA #205598 |
ORIG-1 |
MACIMORELIN ACETATE |
NOVO |
Type 1 - New Molecular Entity |
Approval |
| 12/20/2017 |
UPTRAVI
NDA #207947 |
SUPPL-5 |
SELEXIPAG |
ACTELION |
Labeling |
Approval |
| 12/20/2017 |
VENCLEXTA
NDA #208573 |
SUPPL-3 |
VENETOCLAX |
ABBVIE |
Efficacy |
Approval |
| 12/20/2017 |
AIRDUO DIGIHALER
NDA #208799 |
SUPPL-2 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
| 12/20/2017 |
AIRDUO RESPICLICK
NDA #208799 |
SUPPL-2 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
TEVA PHARM |
Labeling |
Approval |
| 12/21/2017 |
SUDAFED 24 HOUR
NDA #020021 |
SUPPL-11 |
PSEUDOEPHEDRINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Labeling |
Approval |
| 12/21/2017 |
ACTOS
NDA #021073 |
SUPPL-49 |
PIOGLITAZONE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/21/2017 |
ACTOPLUS MET
NDA #021842 |
SUPPL-22 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/21/2017 |
DUETACT
NDA #021925 |
SUPPL-17 |
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/21/2017 |
ACTOPLUS MET XR
NDA #022024 |
SUPPL-14 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/21/2017 |
OSENI
NDA #022426 |
SUPPL-10 |
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/21/2017 |
VARITHENA
NDA #205098 |
SUPPL-26 |
POLIDOCANOL |
PROVENSIS |
Labeling |
Approval |
| 12/21/2017 |
ZYKADIA
NDA #205755 |
SUPPL-10 |
CERITINIB |
NOVARTIS |
Efficacy |
Approval |
| 12/21/2017 |
IBUPROFEN
ANDA #206999 |
ORIG-1 |
IBUPROFEN |
ASCENT PHARMS INC |
|
Approval |
| 12/21/2017 |
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
NDA #208374 |
ORIG-1 |
BIVALIRUDIN |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/21/2017 |
METHYLNALTREXONE BROMIDE
ANDA #208594 |
ORIG-1 |
METHYLNALTREXONE BROMIDE |
MYLAN PHARMS INC |
|
Tentative Approval |
| 12/21/2017 |
SIKLOS
NDA #208843 |
ORIG-1 |
HYDROXYUREA |
THERAVIA |
Type 3 - New Dosage Form |
Approval |
| 12/21/2017 |
OXYBUTYNIN CHLORIDE
ANDA #209025 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
RISING |
|
Approval |
| 12/21/2017 |
EZETIMIBE
ANDA #209234 |
ORIG-1 |
EZETIMIBE |
ALKEM LABS LTD |
|
Approval |
| 12/21/2017 |
GIAPREZA
NDA #209360 |
ORIG-1 |
ANGIOTENSIN II ACETATE |
LA JOLLA PHARMA |
Type 1 - New Molecular Entity |
Approval |
| 12/22/2017 |
XYLOCAINE
NDA #006488 |
SUPPL-90 |
LIDOCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2017 |
XYLOCAINE
NDA #006488 |
SUPPL-95 |
LIDOCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/22/2017 |
XYLOCAINE W/ EPINEPHRINE
NDA #006488 |
SUPPL-90 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2017 |
XYLOCAINE W/ EPINEPHRINE
NDA #006488 |
SUPPL-95 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/22/2017 |
DRAXIMAGE DTPA
NDA #018511 |
SUPPL-20 |
TECHNETIUM TC-99M PENTETATE KIT |
JUBILANT |
Manufacturing (CMC) |
Approval |
| 12/22/2017 |
BETAGAN
NDA #019219 |
SUPPL-29 |
LEVOBUNOLOL HYDROCHLORIDE |
ALLERGAN |
Labeling |
Approval |
| 12/22/2017 |
CETROTIDE
NDA #021197 |
SUPPL-18 |
CETRORELIX ACETATE |
EMD SERONO INC |
Labeling |
Approval |
| 12/22/2017 |
CHLORAPREP ONE-STEP SEPP
NDA #021555 |
SUPPL-20 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
BECTON DICKINSON CO |
Manufacturing (CMC) |
Approval |
| 12/22/2017 |
CHLORAPREP SINGLE SWABSTICK
NDA #021555 |
SUPPL-20 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
BECTON DICKINSON CO |
Manufacturing (CMC) |
Approval |
| 12/22/2017 |
CHLORAPREP TRIPLE SWABSTICK
NDA #021555 |
SUPPL-20 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
BECTON DICKINSON CO |
Manufacturing (CMC) |
Approval |
| 12/22/2017 |
NEXAVAR
NDA #021923 |
SUPPL-18 |
SORAFENIB TOSYLATE |
BAYER HLTHCARE |
Efficacy |
Approval |
| 12/22/2017 |
TASIGNA
NDA #022068 |
SUPPL-26 |
NILOTINIB HYDROCHLORIDE |
NOVARTIS |
Efficacy |
Approval |
| 12/22/2017 |
FERAHEME
NDA #022180 |
SUPPL-16 |
FERUMOXYTOL |
COVIS |
Labeling |
Approval |
| 12/22/2017 |
MITOSOL
NDA #022572 |
SUPPL-5 |
MITOMYCIN |
MOBIUS THERAP |
Labeling |
Approval |
| 12/22/2017 |
PROPOFOL
ANDA #075102 |
SUPPL-38 |
PROPOFOL |
SAGENT PHARMS INC |
Labeling |
Approval |
| 12/22/2017 |
DILANTIN
ANDA #084349 |
SUPPL-81 |
PHENYTOIN SODIUM |
VIATRIS |
Labeling |
Approval |
| 12/22/2017 |
DILANTIN
ANDA #084349 |
SUPPL-82 |
PHENYTOIN SODIUM |
VIATRIS |
Labeling |
Approval |
| 12/22/2017 |
DILANTIN
ANDA #084349 |
SUPPL-84 |
PHENYTOIN SODIUM |
VIATRIS |
Labeling |
Approval |
| 12/22/2017 |
DILANTIN
ANDA #084427 |
SUPPL-38 |
PHENYTOIN |
PHARMACIA |
Labeling |
Approval |
| 12/22/2017 |
DILANTIN
ANDA #084427 |
SUPPL-39 |
PHENYTOIN |
PHARMACIA |
Labeling |
Approval |
| 12/22/2017 |
DILANTIN
ANDA #084427 |
SUPPL-41 |
PHENYTOIN |
PHARMACIA |
Labeling |
Approval |
| 12/22/2017 |
PROCYSBI
NDA #203389 |
SUPPL-20 |
CYSTEAMINE BITARTRATE |
HORIZON |
Efficacy |
Approval |
| 12/22/2017 |
MELPHALAN HYDROCHLORIDE
ANDA #203393 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 12/22/2017 |
LORAZEPAM
ANDA #203572 |
ORIG-1 |
LORAZEPAM |
AUROLIFE PHARMA LLC |
|
Approval |
| 12/22/2017 |
ABACAVIR SULFATE
ANDA #206725 |
ORIG-1 |
ABACAVIR SULFATE |
MICRO LABS LTD |
|
Tentative Approval |
| 12/22/2017 |
LUMIFY
NDA #208144 |
ORIG-1 |
BRIMONIDINE TARTRATE |
BAUSCH AND LOMB INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/22/2017 |
CALCIUM GLUCONATE
NDA #208418 |
SUPPL-1 |
CALCIUM GLUCONATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2017 |
CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #208418 |
SUPPL-1 |
CALCIUM GLUCONATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2017 |
TAZAROTENE
ANDA #208662 |
ORIG-1 |
TAZAROTENE |
COSETTE |
|
Approval |
| 12/22/2017 |
EZETIMIBE AND SIMVASTATIN
ANDA #209222 |
ORIG-1 |
EZETIMIBE; SIMVASTATIN |
ALKEM LABS LTD |
|
Approval |
| 12/22/2017 |
CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #209274 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE |
GRANULES |
|
Approval |
| 12/22/2017 |
OXYBUTYNIN CHLORIDE
ANDA #209335 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
ABHAI LLC |
|
Approval |
| 12/22/2017 |
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #209423 |
ORIG-1 |
DROSPIRENONE; ETHINYL ESTRADIOL |
JUBILANT CADISTA |
|
Approval |
| 12/22/2017 |
METHOTREXATE SODIUM
ANDA #210040 |
ORIG-1 |
METHOTREXATE SODIUM |
AMNEAL PHARMS |
|
Approval |
| 12/26/2017 |
DRAXIMAGE DTPA
NDA #018511 |
SUPPL-28 |
TECHNETIUM TC-99M PENTETATE KIT |
JUBILANT |
Efficacy |
Approval |
| 12/26/2017 |
CHILDREN'S ADVIL
NDA #020944 |
SUPPL-13 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 12/26/2017 |
JUNIOR STRENGTH ADVIL
NDA #020944 |
SUPPL-13 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
| 12/26/2017 |
METFORMIN HYDROCHLORIDE
ANDA #203832 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
NOSTRUM LABS INC |
|
Approval |
| 12/26/2017 |
DESIPRAMINE HYDROCHLORIDE
ANDA #204963 |
ORIG-1 |
DESIPRAMINE HYDROCHLORIDE |
NOVAST LABS |
|
Approval |
| 12/26/2017 |
FONDAPARINUX SODIUM
ANDA #206918 |
ORIG-1 |
FONDAPARINUX SODIUM |
EUGIA PHARMA |
|
Approval |
| 12/26/2017 |
CALCIPOTRIENE
ANDA #207163 |
ORIG-1 |
CALCIPOTRIENE |
CHARTWELL RX |
|
Approval |
| 12/26/2017 |
TRIAMCINOLONE ACETONIDE
ANDA #207651 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
ALKEM LABS LTD |
|
Approval |
| 12/26/2017 |
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #207730 |
ORIG-1 |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CROWN LABS INC |
|
Approval |
| 12/26/2017 |
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #207731 |
ORIG-1 |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CROWN LABS INC |
|
Approval |
| 12/26/2017 |
FLUOCINOLONE ACETONIDE
ANDA #209596 |
ORIG-1 |
FLUOCINOLONE ACETONIDE |
CHARTWELL RX |
|
Approval |
| 12/26/2017 |
FLUOROURACIL
ANDA #210124 |
ORIG-1 |
FLUOROURACIL |
GLAND PHARMA LTD |
|
Approval |
| 12/26/2017 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #210369 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
GLENMARK PHARMS LTD |
|
Approval |
| 12/27/2017 |
DICYCLOMINE HYDROCHLORIDE
ANDA #040169 |
SUPPL-4 |
DICYCLOMINE HYDROCHLORIDE |
GENERICS |
Labeling |
Approval |
| 12/27/2017 |
KETOROLAC TROMETHAMINE
ANDA #077308 |
SUPPL-7 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 12/27/2017 |
GALANTAMINE HYDROBROMIDE
ANDA #077604 |
SUPPL-2 |
GALANTAMINE HYDROBROMIDE |
YABAO PHARM |
Labeling |
Approval |
| 12/27/2017 |
LEVALBUTEROL HYDROCHLORIDE
ANDA #077756 |
SUPPL-3 |
LEVALBUTEROL HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
| 12/27/2017 |
IRINOTECAN HYDROCHLORIDE
ANDA #078796 |
SUPPL-7 |
IRINOTECAN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 12/27/2017 |
DOXYCYCLINE HYCLATE
ANDA #090134 |
SUPPL-14 |
DOXYCYCLINE HYCLATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 12/27/2017 |
DOXYCYCLINE HYCLATE
ANDA #090134 |
SUPPL-15 |
DOXYCYCLINE HYCLATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 12/27/2017 |
DOXYCYCLINE HYCLATE
ANDA #090134 |
SUPPL-17 |
DOXYCYCLINE HYCLATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 12/27/2017 |
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
ANDA #091632 |
SUPPL-5 |
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX |
TRIS PHARMA INC |
Manufacturing (CMC) |
Approval |
| 12/27/2017 |
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
ANDA #091632 |
SUPPL-17 |
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX |
TRIS PHARMA INC |
Labeling |
Approval |
| 12/27/2017 |
CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #200154 |
SUPPL-8 |
CISATRACURIUM BESYLATE |
SANDOZ INC |
Labeling |
Approval |
| 12/27/2017 |
DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200540 |
SUPPL-3 |
DICLOFENAC SODIUM; MISOPROSTOL |
EXELA HOLDINGS |
Labeling |
Approval |
| 12/27/2017 |
DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200540 |
SUPPL-5 |
DICLOFENAC SODIUM; MISOPROSTOL |
EXELA HOLDINGS |
Labeling |
Approval |
| 12/27/2017 |
DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200540 |
SUPPL-6 |
DICLOFENAC SODIUM; MISOPROSTOL |
EXELA HOLDINGS |
Labeling |
Approval |
| 12/27/2017 |
GLIMEPIRIDE
ANDA #202759 |
SUPPL-6 |
GLIMEPIRIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203027 |
SUPPL-3 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203027 |
SUPPL-4 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203027 |
SUPPL-5 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203027 |
SUPPL-6 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 12/27/2017 |
PHENDIMETRAZINE TARTRATE
ANDA #203600 |
ORIG-1 |
PHENDIMETRAZINE TARTRATE |
NOSTRUM LABS INC |
|
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646 |
SUPPL-6 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646 |
SUPPL-7 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646 |
SUPPL-8 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/27/2017 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203646 |
SUPPL-9 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/27/2017 |
JAIMIESS
ANDA #203770 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
|
Approval |
| 12/27/2017 |
FLUDEOXYGLUCOSE F18
ANDA #204264 |
SUPPL-1 |
FLUDEOXYGLUCOSE F-18 |
PHARMALOGIC |
Manufacturing (CMC) |
Approval |
| 12/27/2017 |
GABAPENTIN
ANDA #205101 |
SUPPL-5 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/27/2017 |
BUTALBITAL AND ACETAMINOPHEN
ANDA #207313 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL |
DR REDDYS LABS SA |
|
Approval |
| 12/27/2017 |
CLOMIPRAMINE HYDROCHLORIDE
ANDA #208961 |
ORIG-1 |
CLOMIPRAMINE HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 12/28/2017 |
CILOSTAZOL
ANDA #077323 |
SUPPL-7 |
CILOSTAZOL |
RISING |
Labeling |
Approval |
| 12/28/2017 |
CILOSTAZOL
ANDA #077323 |
SUPPL-8 |
CILOSTAZOL |
RISING |
Labeling |
Approval |
| 12/28/2017 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #209799 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
NUVO PHARM |
|
Approval |
| 12/28/2017 |
OXYCODONE AND ACETAMINOPHEN
ANDA #210079 |
ORIG-1 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
NESHER PHARMS |
|
Approval |
| 12/29/2017 |
THALOMID
NDA #020785 |
SUPPL-65 |
THALIDOMIDE |
BRISTOL-MYERS |
Labeling |
Approval |
| 12/29/2017 |
REVLIMID
NDA #021880 |
SUPPL-55 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 12/29/2017 |
VALACYCLOVIR HYDROCHLORIDE
ANDA #079137 |
ORIG-1 |
VALACYCLOVIR HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
|
Approval |
| 12/29/2017 |
LAMOTRIGINE
ANDA #201168 |
SUPPL-1 |
LAMOTRIGINE |
ALEMBIC |
Labeling |
Approval |
| 12/29/2017 |
LAMOTRIGINE
ANDA #201168 |
SUPPL-3 |
LAMOTRIGINE |
ALEMBIC |
Labeling |
Approval |
| 12/29/2017 |
LAMOTRIGINE
ANDA #201168 |
SUPPL-4 |
LAMOTRIGINE |
ALEMBIC |
Labeling |
Approval |
| 12/29/2017 |
POMALYST
NDA #204026 |
SUPPL-19 |
POMALIDOMIDE |
BRISTOL |
Labeling |
Approval |
| 12/29/2017 |
PROVAYBLUE
NDA #204630 |
SUPPL-5 |
METHYLENE BLUE |
PROVEPHARM SAS |
Labeling |
Approval |
| 12/29/2017 |
PIROXICAM
ANDA #206152 |
ORIG-1 |
PIROXICAM |
MICRO LABS |
|
Approval |
| 12/29/2017 |
ZOLEDRONIC ACID
ANDA #207341 |
ORIG-1 |
ZOLEDRONIC ACID |
BPI LABS |
|
Approval |
| 12/29/2017 |
BROMFENAC SODIUM
ANDA #207584 |
ORIG-1 |
BROMFENAC SODIUM |
PADDOCK LABS |
|
Tentative Approval |
| 12/29/2017 |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #208369 |
ORIG-1 |
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 12/29/2017 |
ESTRADIOL
ANDA #208788 |
ORIG-1 |
ESTRADIOL |
MYLAN |
|
Approval |
| 12/29/2017 |
GANZYK-RTU
NDA #209347 |
SUPPL-3 |
GANCICLOVIR |
EXELA PHARMA |
Labeling |
Approval |
| 12/29/2017 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #210354 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
ASCENT PHARMS INC |
|
Approval |
