| 12/02/2019 |
SOLAGE
NDA #020922 |
SUPPL-7 |
MEQUINOL; TRETINOIN |
ALMIRALL |
Labeling |
Approval |
| 12/02/2019 |
MELOXICAM
ANDA #078008 |
SUPPL-15 |
MELOXICAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/02/2019 |
MELOXICAM
ANDA #078008 |
SUPPL-16 |
MELOXICAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/02/2019 |
XURIDEN
NDA #208169 |
SUPPL-3 |
URIDINE TRIACETATE |
BTG INTL |
Efficacy |
Approval |
| 12/02/2019 |
SUCRALFATE
ANDA #209356 |
ORIG-1 |
SUCRALFATE |
AMNEAL |
|
Approval |
| 12/02/2019 |
LORCASERIN HYDROCHLORIDE
ANDA #209464 |
ORIG-1 |
LORCASERIN HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
| 12/02/2019 |
STERILE WATER FOR INJECTION
ANDA #211188 |
ORIG-1 |
STERILE WATER FOR INJECTION |
MEDEFIL INC |
|
Approval |
| 12/03/2019 |
APOKYN
NDA #021264 |
SUPPL-17 |
APOMORPHINE HYDROCHLORIDE |
MDD US |
Labeling |
Approval |
| 12/03/2019 |
INCRELEX
BLA #021839 |
SUPPL-24 |
MECASERMIN RECOMBINANT |
IPSEN INC |
|
Approval |
| 12/03/2019 |
TERBINAFINE HYDROCHLORIDE
ANDA #078297 |
SUPPL-16 |
TERBINAFINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/03/2019 |
TERBINAFINE HYDROCHLORIDE
ANDA #078297 |
SUPPL-17 |
TERBINAFINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/03/2019 |
TERBINAFINE HYDROCHLORIDE
ANDA #078297 |
SUPPL-18 |
TERBINAFINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/03/2019 |
TERBINAFINE HYDROCHLORIDE
ANDA #078297 |
SUPPL-20 |
TERBINAFINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/03/2019 |
NAPROXEN SODIUM
ANDA #078432 |
SUPPL-4 |
NAPROXEN SODIUM |
AMNEAL PHARMS NY |
Labeling |
Approval |
| 12/03/2019 |
NAPROXEN SODIUM
ANDA #078432 |
SUPPL-6 |
NAPROXEN SODIUM |
AMNEAL PHARMS NY |
Labeling |
Approval |
| 12/03/2019 |
NAPROXEN SODIUM
ANDA #078432 |
SUPPL-9 |
NAPROXEN SODIUM |
AMNEAL PHARMS NY |
Labeling |
Approval |
| 12/03/2019 |
GALANTAMINE HYDROBROMIDE
ANDA #090178 |
SUPPL-9 |
GALANTAMINE HYDROBROMIDE |
SUN PHARM |
Labeling |
Approval |
| 12/03/2019 |
MINOCYCLINE HYDROCHLORIDE
ANDA #091118 |
ORIG-2 |
MINOCYCLINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
|
Approval |
| 12/03/2019 |
MINOCYCLINE HYDROCHLORIDE
ANDA #091118 |
ORIG-3 |
MINOCYCLINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
|
Tentative Approval |
| 12/03/2019 |
ESZOPICLONE
ANDA #202929 |
SUPPL-8 |
ESZOPICLONE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/03/2019 |
ESZOPICLONE
ANDA #202929 |
SUPPL-9 |
ESZOPICLONE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/03/2019 |
ESZOPICLONE
ANDA #202929 |
SUPPL-13 |
ESZOPICLONE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/03/2019 |
ZOLMITRIPTAN
ANDA #204041 |
SUPPL-3 |
ZOLMITRIPTAN |
AJANTA PHARMA LTD |
Labeling |
Approval |
| 12/03/2019 |
SIRTURO
NDA #204384 |
SUPPL-11 |
BEDAQUILINE FUMARATE |
JANSSEN THERAP |
Labeling |
Approval |
| 12/03/2019 |
JYNARQUE
NDA #204441 |
SUPPL-7 |
TOLVAPTAN |
OTSUKA |
REMS |
Approval |
| 12/03/2019 |
NAFTIFINE HYDROCHLORIDE
ANDA #205975 |
SUPPL-1 |
NAFTIFINE HYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 12/03/2019 |
NAFTIFINE HYDROCHLORIDE
ANDA #206901 |
SUPPL-1 |
NAFTIFINE HYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 12/03/2019 |
NAFTIFINE HYDROCHLORIDE
ANDA #206901 |
SUPPL-2 |
NAFTIFINE HYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 12/03/2019 |
DESCOVY
NDA #208215 |
SUPPL-11 |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 12/03/2019 |
ODEFSEY
NDA #208351 |
SUPPL-10 |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 12/03/2019 |
OSELTAMIVIR PHOSPHATE
ANDA #209113 |
SUPPL-2 |
OSELTAMIVIR PHOSPHATE |
ZYDUS PHARMS |
Labeling |
Approval |
| 12/03/2019 |
OSELTAMIVIR PHOSPHATE
ANDA #209113 |
SUPPL-3 |
OSELTAMIVIR PHOSPHATE |
ZYDUS PHARMS |
Labeling |
Approval |
| 12/03/2019 |
OSELTAMIVIR PHOSPHATE
ANDA #209113 |
SUPPL-5 |
OSELTAMIVIR PHOSPHATE |
ZYDUS PHARMS |
Labeling |
Approval |
| 12/03/2019 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
ANDA #209837 |
SUPPL-4 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
PERRIGO R AND D |
Labeling |
Approval |
| 12/03/2019 |
DICLOFENAC POTASSIUM
ANDA #210078 |
ORIG-1 |
DICLOFENAC POTASSIUM |
STRIDES PHARMA |
|
Approval |
| 12/03/2019 |
GABAPENTIN
ANDA #211330 |
ORIG-1 |
GABAPENTIN |
PAI HOLDINGS PHARM |
|
Approval |
| 12/03/2019 |
VIGABATRIN
ANDA #211592 |
ORIG-1 |
VIGABATRIN |
INVAGEN PHARMS |
|
Approval |
| 12/03/2019 |
TECENTRIQ
BLA #761034 |
SUPPL-21 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 12/04/2019 |
CARDIOLITE
NDA #019785 |
SUPPL-22 |
TECHNETIUM TC-99M SESTAMIBI KIT |
LANTHEUS MEDCL |
Labeling |
Approval |
| 12/04/2019 |
MIRALUMA
NDA #019785 |
SUPPL-22 |
TECHNETIUM TC-99M SESTAMIBI KIT |
LANTHEUS MEDCL |
Labeling |
Approval |
| 12/04/2019 |
THALOMID
NDA #020785 |
SUPPL-68 |
THALIDOMIDE |
BRISTOL-MYERS |
Labeling |
Approval |
| 12/04/2019 |
EXTRANEAL
NDA #021321 |
SUPPL-37 |
ICODEXTRIN |
BAXTER HLTHCARE |
REMS |
Approval |
| 12/04/2019 |
AMOXICILLIN
ANDA #061926 |
SUPPL-131 |
AMOXICILLIN |
TEVA |
Labeling |
Approval |
| 12/04/2019 |
AMOXICILLIN
ANDA #061931 |
SUPPL-52 |
AMOXICILLIN |
TEVA |
Labeling |
Approval |
| 12/04/2019 |
AMOXICILLIN PEDIATRIC
ANDA #061931 |
SUPPL-52 |
AMOXICILLIN |
TEVA |
Labeling |
Approval |
| 12/04/2019 |
AMOXICILLIN
ANDA #064013 |
SUPPL-57 |
AMOXICILLIN |
TEVA |
Labeling |
Approval |
| 12/04/2019 |
MEMANTINE HYDROCHLORIDE
ANDA #090058 |
SUPPL-5 |
MEMANTINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 12/04/2019 |
MEMANTINE HYDROCHLORIDE
ANDA #090058 |
SUPPL-11 |
MEMANTINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 12/04/2019 |
ALDURAZYME
BLA #125058 |
SUPPL-244 |
LARONIDASE |
BIOMARIN |
|
Approval |
| 12/04/2019 |
VIMIZIM
BLA #125460 |
SUPPL-17 |
ELOSULFASE ALFA |
BIOMARIN PHARM |
|
Approval |
| 12/04/2019 |
LATUDA
NDA #200603 |
SUPPL-35 |
LURASIDONE HYDROCHLORIDE |
SUNOVION PHARMS INC |
Labeling |
Approval |
| 12/04/2019 |
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
ANDA #205833 |
SUPPL-8 |
MOXIFLOXACIN HYDROCHLORIDE |
MYLAN LABS LTD |
Labeling |
Approval |
| 12/04/2019 |
FINGOLIMOD HYDROCHLORIDE
ANDA #207979 |
ORIG-1 |
FINGOLIMOD HYDROCHLORIDE |
BIOCON LTD |
|
Approval |
| 12/04/2019 |
FINGOLIMOD HYDROCHLORIDE
ANDA #208014 |
ORIG-1 |
FINGOLIMOD HYDROCHLORIDE |
SUN PHARM |
|
Approval |
| 12/04/2019 |
MINOXIDIL (FOR MEN)
ANDA #209074 |
SUPPL-1 |
MINOXIDIL |
TARO |
Labeling |
Approval |
| 12/04/2019 |
MINOXIDIL (FOR MEN)
ANDA #209074 |
SUPPL-2 |
MINOXIDIL |
TARO |
Labeling |
Approval |
| 12/04/2019 |
MINOXIDIL (FOR WOMEN)
ANDA #209074 |
SUPPL-1 |
MINOXIDIL |
TARO |
Labeling |
Approval |
| 12/04/2019 |
MINOXIDIL (FOR WOMEN)
ANDA #209074 |
SUPPL-2 |
MINOXIDIL |
TARO |
Labeling |
Approval |
| 12/04/2019 |
HARVONI
NDA #212477 |
SUPPL-4 |
LEDIPASVIR; SOFOSBUVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 12/04/2019 |
SOVALDI
NDA #212480 |
SUPPL-3 |
SOFOSBUVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 12/04/2019 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #212791 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
SLAYBACK PHARMA LLC |
|
Approval |
| 12/05/2019 |
SENSIPAR
NDA #021688 |
SUPPL-27 |
CINACALCET HYDROCHLORIDE |
AMGEN |
Labeling |
Approval |
| 12/05/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #040659 |
SUPPL-8 |
MECLIZINE HYDROCHLORIDE |
JUBILANT CADISTA |
Labeling |
Approval |
| 12/05/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #040659 |
SUPPL-10 |
MECLIZINE HYDROCHLORIDE |
JUBILANT CADISTA |
Labeling |
Approval |
| 12/05/2019 |
SYLVANT
BLA #125496 |
SUPPL-18 |
SILTUXIMAB |
EUSA PHARMA LIMITED |
|
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-4 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-5 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-6 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-7 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-10 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-13 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #202632 |
SUPPL-14 |
MOXIFLOXACIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/05/2019 |
DUOPA
NDA #203952 |
SUPPL-10 |
CARBIDOPA; LEVODOPA |
ABBVIE |
Labeling |
Approval |
| 12/05/2019 |
EMGALITY
BLA #761063 |
SUPPL-4 |
GALCANEZUMAB-GNLM |
ELI LILLY AND CO |
|
Approval |
| 12/06/2019 |
ABRAXANE
NDA #021660 |
SUPPL-46 |
PACLITAXEL |
BRISTOL-MYERS |
Efficacy |
Approval |
| 12/06/2019 |
ARGATROBAN IN SODIUM CHLORIDE
NDA #022434 |
SUPPL-13 |
ARGATROBAN |
CIPLA |
Labeling |
Approval |
| 12/06/2019 |
NEVIRAPINE
ANDA #077956 |
SUPPL-22 |
NEVIRAPINE |
CIPLA |
Labeling |
Approval |
| 12/06/2019 |
NEVIRAPINE
ANDA #077956 |
SUPPL-23 |
NEVIRAPINE |
CIPLA |
Labeling |
Approval |
| 12/06/2019 |
NEVIRAPINE
ANDA #077956 |
SUPPL-24 |
NEVIRAPINE |
CIPLA |
Labeling |
Approval |
| 12/06/2019 |
ZALEPLON
ANDA #078147 |
SUPPL-2 |
ZALEPLON |
HIKMA PHARMS |
Labeling |
Approval |
| 12/06/2019 |
GALANTAMINE HYDROBROMIDE
ANDA #078484 |
SUPPL-8 |
GALANTAMINE HYDROBROMIDE |
IMPAX LABS |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078947 |
SUPPL-32 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078947 |
SUPPL-33 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078947 |
SUPPL-34 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078956 |
SUPPL-21 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078956 |
SUPPL-23 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078956 |
SUPPL-26 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #078956 |
SUPPL-29 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #079132 |
SUPPL-20 |
LAMOTRIGINE |
JUBILANT CADISTA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #079132 |
SUPPL-23 |
LAMOTRIGINE |
JUBILANT CADISTA |
Labeling |
Approval |
| 12/06/2019 |
PROPYLTHIOURACIL
ANDA #080172 |
SUPPL-57 |
PROPYLTHIOURACIL |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 12/06/2019 |
PROPYLTHIOURACIL
ANDA #080172 |
SUPPL-60 |
PROPYLTHIOURACIL |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #090401 |
SUPPL-16 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #090401 |
SUPPL-19 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #090401 |
SUPPL-23 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #090401 |
SUPPL-24 |
LAMOTRIGINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/06/2019 |
DIDANOSINE
ANDA #090788 |
SUPPL-4 |
DIDANOSINE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/06/2019 |
DIDANOSINE
ANDA #090788 |
SUPPL-7 |
DIDANOSINE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/06/2019 |
DIDANOSINE
ANDA #090788 |
SUPPL-8 |
DIDANOSINE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #200220 |
SUPPL-6 |
LAMOTRIGINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #200220 |
SUPPL-7 |
LAMOTRIGINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/06/2019 |
NAPROXEN SODIUM
ANDA #200629 |
SUPPL-6 |
NAPROXEN SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/06/2019 |
NAPROXEN SODIUM
ANDA #200629 |
SUPPL-7 |
NAPROXEN SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/06/2019 |
NAPROXEN SODIUM
ANDA #200629 |
SUPPL-10 |
NAPROXEN SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/06/2019 |
ALOSETRON HYDROCHLORIDE
ANDA #200652 |
SUPPL-5 |
ALOSETRON HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #200694 |
SUPPL-1 |
LAMOTRIGINE |
ALKEM LABS LTD |
Labeling |
Approval |
| 12/06/2019 |
LAMOTRIGINE
ANDA #200694 |
SUPPL-3 |
LAMOTRIGINE |
ALKEM LABS LTD |
Labeling |
Approval |
| 12/06/2019 |
QUETIAPINE FUMARATE
ANDA #203359 |
SUPPL-9 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/06/2019 |
QUETIAPINE FUMARATE
ANDA #203359 |
SUPPL-13 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/06/2019 |
ARIPIPRAZOLE
ANDA #204171 |
SUPPL-3 |
ARIPIPRAZOLE |
LANNETT CO INC |
Labeling |
Approval |
| 12/06/2019 |
ZOLMITRIPTAN
ANDA #204232 |
SUPPL-6 |
ZOLMITRIPTAN |
ALEMBIC |
Labeling |
Approval |
| 12/06/2019 |
MONTELUKAST SODIUM
ANDA #204604 |
SUPPL-1 |
MONTELUKAST SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/06/2019 |
MONTELUKAST SODIUM
ANDA #204604 |
SUPPL-2 |
MONTELUKAST SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/06/2019 |
MONTELUKAST SODIUM
ANDA #204604 |
SUPPL-3 |
MONTELUKAST SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/06/2019 |
CELECOXIB
ANDA #204776 |
SUPPL-3 |
CELECOXIB |
MICRO LABS |
Labeling |
Approval |
| 12/06/2019 |
CELECOXIB
ANDA #204776 |
SUPPL-6 |
CELECOXIB |
MICRO LABS |
Labeling |
Approval |
| 12/06/2019 |
KITABIS PAK
NDA #205433 |
SUPPL-5 |
TOBRAMYCIN |
PULMOFLOW INC |
Labeling |
Approval |
| 12/06/2019 |
ALOSETRON HYDROCHLORIDE
ANDA #206113 |
SUPPL-2 |
ALOSETRON HYDROCHLORIDE |
PAR PHARM INC |
Labeling |
Approval |
| 12/06/2019 |
VIEKIRA PAK (COPACKAGED)
NDA #206619 |
SUPPL-20 |
DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/06/2019 |
ALOSETRON HYDROCHLORIDE
ANDA #206647 |
SUPPL-4 |
ALOSETRON HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/06/2019 |
TECHNIVIE
NDA #207931 |
SUPPL-13 |
OMBITASVIR; PARITAPREVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/06/2019 |
VIEKIRA XR
NDA #208624 |
SUPPL-8 |
DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/06/2019 |
MEPSEVII
BLA #761047 |
SUPPL-3 |
VESTRONIDASE ALFA-VJBK |
ULTRAGENYX PHARM INC |
|
Approval |
| 12/06/2019 |
BRINEURA
BLA #761052 |
SUPPL-7 |
CERLIPONASE ALFA |
BIOMARIN PHARM |
|
Approval |
| 12/06/2019 |
AVSOLA
BLA #761086 |
ORIG-1 |
INFLIXIMAB-AXXQ |
AMGEN INC |
|
Approval |
| 12/09/2019 |
NAPROXEN SODIUM
NDA #021920 |
SUPPL-26 |
NAPROXEN SODIUM |
BIONPHARMA |
Labeling |
Approval |
| 12/09/2019 |
VALPROIC ACID
ANDA #073484 |
SUPPL-31 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 12/09/2019 |
VALPROIC ACID
ANDA #073484 |
SUPPL-32 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 12/09/2019 |
VALPROIC ACID
ANDA #073484 |
SUPPL-34 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 12/09/2019 |
VALPROIC ACID
ANDA #073484 |
SUPPL-37 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 12/09/2019 |
VALPROIC ACID
ANDA #073484 |
SUPPL-38 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #077004 |
SUPPL-2 |
RAMIPRIL |
CIPLA |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #077004 |
SUPPL-4 |
RAMIPRIL |
CIPLA |
Labeling |
Approval |
| 12/09/2019 |
RISPERIDONE
ANDA #077494 |
SUPPL-15 |
RISPERIDONE |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/09/2019 |
RISPERIDONE
ANDA #077494 |
SUPPL-16 |
RISPERIDONE |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #077900 |
SUPPL-13 |
RAMIPRIL |
HIKMA |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #077900 |
SUPPL-14 |
RAMIPRIL |
HIKMA |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #079116 |
SUPPL-8 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #079116 |
SUPPL-9 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 12/09/2019 |
RAMIPRIL
ANDA #079116 |
SUPPL-10 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 12/09/2019 |
BETHKIS
NDA #201820 |
SUPPL-5 |
TOBRAMYCIN |
CHIESI |
Labeling |
Approval |
| 12/09/2019 |
FENOFIBRATE (MICRONIZED)
ANDA #202252 |
SUPPL-4 |
FENOFIBRATE |
APOTEX |
Labeling |
Approval |
| 12/09/2019 |
FENOFIBRATE (MICRONIZED)
ANDA #202252 |
SUPPL-5 |
FENOFIBRATE |
APOTEX |
Labeling |
Approval |
| 12/09/2019 |
FENOFIBRATE (MICRONIZED)
ANDA #202252 |
SUPPL-6 |
FENOFIBRATE |
APOTEX |
Labeling |
Approval |
| 12/09/2019 |
FENOFIBRATE (MICRONIZED)
ANDA #202252 |
SUPPL-7 |
FENOFIBRATE |
APOTEX |
Labeling |
Approval |
| 12/09/2019 |
RILUZOLE
ANDA #206045 |
ORIG-1 |
RILUZOLE |
KENTON |
|
Approval |
| 12/09/2019 |
CRESEMBA
NDA #207500 |
SUPPL-5 |
ISAVUCONAZONIUM SULFATE |
ASTELLAS |
Labeling |
Approval |
| 12/09/2019 |
CRESEMBA
NDA #207501 |
SUPPL-4 |
ISAVUCONAZONIUM SULFATE |
ASTELLAS |
Labeling |
Approval |
| 12/09/2019 |
EVEROLIMUS
ANDA #207934 |
ORIG-1 |
EVEROLIMUS |
ENDO OPERATIONS |
|
Approval |
| 12/09/2019 |
SODIUM TETRADECYL SULFATE
ANDA #209937 |
ORIG-1 |
SODIUM TETRADECYL SULFATE |
HIKMA |
|
Approval |
| 12/09/2019 |
EVEROLIMUS
ANDA #210050 |
ORIG-1 |
EVEROLIMUS |
TEVA PHARMS USA |
|
Approval |
| 12/09/2019 |
AMBRISENTAN
ANDA #210058 |
SUPPL-1 |
AMBRISENTAN |
ZYDUS PHARMS |
Labeling |
Approval |
| 12/09/2019 |
AMBRISENTAN
ANDA #210058 |
SUPPL-2 |
AMBRISENTAN |
ZYDUS PHARMS |
Labeling |
Approval |
| 12/10/2019 |
VALTREX
NDA #020487 |
SUPPL-20 |
VALACYCLOVIR HYDROCHLORIDE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/10/2019 |
FORFIVO XL
NDA #022497 |
SUPPL-8 |
BUPROPION HYDROCHLORIDE |
TWI PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #076720 |
SUPPL-22 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #076720 |
SUPPL-24 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #076720 |
SUPPL-25 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #076733 |
SUPPL-21 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #076733 |
SUPPL-23 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #076733 |
SUPPL-24 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
NEVIRAPINE
ANDA #077521 |
SUPPL-18 |
NEVIRAPINE |
AUROBINDO |
Labeling |
Approval |
| 12/10/2019 |
NEVIRAPINE
ANDA #077521 |
SUPPL-20 |
NEVIRAPINE |
AUROBINDO |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #077855 |
SUPPL-19 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #077855 |
SUPPL-21 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
MORPHINE SULFATE
ANDA #077855 |
SUPPL-22 |
MORPHINE SULFATE |
NESHER PHARMS |
Labeling |
Approval |
| 12/10/2019 |
NAPROXEN SODIUM
ANDA #078486 |
SUPPL-2 |
NAPROXEN SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/10/2019 |
NAPROXEN SODIUM
ANDA #078486 |
SUPPL-3 |
NAPROXEN SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/10/2019 |
NAPROXEN SODIUM
ANDA #078486 |
SUPPL-4 |
NAPROXEN SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/10/2019 |
NAPROXEN SODIUM
ANDA #078486 |
SUPPL-7 |
NAPROXEN SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/10/2019 |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #202491 |
SUPPL-1 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/10/2019 |
ARIPIPRAZOLE
ANDA #203906 |
SUPPL-7 |
ARIPIPRAZOLE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/10/2019 |
XOFIGO
NDA #203971 |
SUPPL-16 |
RADIUM RA-223 DICHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 12/10/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 12/10/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635 |
SUPPL-3 |
MOXIFLOXACIN HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 12/10/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635 |
SUPPL-4 |
MOXIFLOXACIN HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 12/10/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #204635 |
SUPPL-6 |
MOXIFLOXACIN HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 12/10/2019 |
DESVENLAFAXINE
NDA #205583 |
SUPPL-10 |
DESVENLAFAXINE FUMARATE |
SUN PHARM |
Labeling |
Approval |
| 12/10/2019 |
NAFCILLIN SODIUM
ANDA #206682 |
ORIG-1 |
NAFCILLIN SODIUM |
FRESENIUS |
|
Approval |
| 12/11/2019 |
PERSANTINE
NDA #012836 |
SUPPL-61 |
DIPYRIDAMOLE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/11/2019 |
AGGRENOX
NDA #020884 |
SUPPL-39 |
ASPIRIN; DIPYRIDAMOLE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/11/2019 |
XERESE
NDA #022436 |
SUPPL-10 |
ACYCLOVIR; HYDROCORTISONE |
BAUSCH |
Labeling |
Approval |
| 12/11/2019 |
QUETIAPINE FUMARATE
ANDA #090120 |
SUPPL-8 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
QUETIAPINE FUMARATE
ANDA #090120 |
SUPPL-9 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
QUETIAPINE FUMARATE
ANDA #090749 |
SUPPL-7 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
QUETIAPINE FUMARATE
ANDA #090749 |
SUPPL-8 |
QUETIAPINE FUMARATE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
ESZOPICLONE
ANDA #091153 |
SUPPL-2 |
ESZOPICLONE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
ESZOPICLONE
ANDA #091153 |
SUPPL-3 |
ESZOPICLONE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
ESZOPICLONE
ANDA #091153 |
SUPPL-4 |
ESZOPICLONE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
CAPECITABINE
ANDA #200483 |
SUPPL-2 |
CAPECITABINE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
CAPECITABINE
ANDA #200483 |
SUPPL-5 |
CAPECITABINE |
HIKMA |
Labeling |
Approval |
| 12/11/2019 |
VAZALORE
NDA #203697 |
SUPPL-4 |
ASPIRIN |
PLX PHARMA |
Labeling |
Approval |
| 12/11/2019 |
TECFIDERA
NDA #204063 |
SUPPL-25 |
DIMETHYL FUMARATE |
BIOGEN INC |
Labeling |
Approval |
| 12/11/2019 |
QUININE SULFATE
ANDA #204372 |
SUPPL-1 |
QUININE SULFATE |
NOVAST LABS |
Labeling |
Approval |
| 12/11/2019 |
ORBACTIV
NDA #206334 |
SUPPL-5 |
ORITAVANCIN DIPHOSPHATE |
MELINTA THERAP |
Labeling |
Approval |
| 12/11/2019 |
ZEPATIER
NDA #208261 |
SUPPL-6 |
ELBASVIR; GRAZOPREVIR |
MSD SUB MERCK |
Labeling |
Approval |
| 12/11/2019 |
QUETIAPINE FUMARATE
ANDA #208947 |
SUPPL-1 |
QUETIAPINE FUMARATE |
NOVAST LABS |
Labeling |
Approval |
| 12/11/2019 |
QUETIAPINE FUMARATE
ANDA #208947 |
SUPPL-2 |
QUETIAPINE FUMARATE |
NOVAST LABS |
Labeling |
Approval |
| 12/11/2019 |
FLUOROURACIL
ANDA #209271 |
ORIG-1 |
FLUOROURACIL |
NOVAST LABS |
|
Approval |
| 12/11/2019 |
DOFETILIDE
ANDA #210466 |
SUPPL-1 |
DOFETILIDE |
SUN PHARM |
Labeling |
Approval |
| 12/11/2019 |
ELURYNG
ANDA #210830 |
ORIG-1 |
ETHINYL ESTRADIOL; ETONOGESTREL |
AMNEAL |
|
Approval |
| 12/11/2019 |
SOLIFENACIN SUCCINATE
ANDA #211423 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
RISING |
|
Approval |
| 12/11/2019 |
AZITHROMYCIN
ANDA #211521 |
ORIG-1 |
AZITHROMYCIN |
TARO |
|
Approval |
| 12/11/2019 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #212037 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ELITE LABS INC |
|
Approval |
| 12/12/2019 |
DIVIGEL
NDA #022038 |
SUPPL-5 |
ESTRADIOL |
VERTICAL PHARMS |
Labeling |
Approval |
| 12/12/2019 |
DIVIGEL
NDA #022038 |
SUPPL-6 |
ESTRADIOL |
VERTICAL PHARMS |
Efficacy |
Approval |
| 12/12/2019 |
PUR-WASH
NDA #022305 |
SUPPL-6 |
PURIFIED WATER |
NIAGARA PHARMS |
Labeling |
Approval |
| 12/12/2019 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #077411 |
SUPPL-28 |
LAMIVUDINE; ZIDOVUDINE |
CIPLA |
Labeling |
Approval |
| 12/12/2019 |
ABACAVIR SULFATE
ANDA #078119 |
SUPPL-25 |
ABACAVIR SULFATE |
CIPLA |
Labeling |
Approval |
| 12/12/2019 |
ELITEK
BLA #103946 |
SUPPL-5103 |
RASBURICASE |
SANOFI SYNTHELABO |
|
Approval |
| 12/12/2019 |
XELJANZ
NDA #203214 |
SUPPL-25 |
TOFACITINIB CITRATE |
PF PRISM CV |
Labeling |
Approval |
| 12/12/2019 |
CARNEXIV
NDA #206030 |
SUPPL-2 |
CARBAMAZEPINE |
LUNDBECK PHARMS LLC |
Labeling |
Approval |
| 12/12/2019 |
IBANDRONATE SODIUM
ANDA #206058 |
SUPPL-1 |
IBANDRONATE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
| 12/12/2019 |
AZELASTINE HYDROCHLORIDE
ANDA #207243 |
SUPPL-1 |
AZELASTINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 12/12/2019 |
TROPICAMIDE
ANDA #207524 |
ORIG-1 |
TROPICAMIDE |
SOMERSET THERAPS LLC |
|
Approval |
| 12/12/2019 |
IMIPENEM AND CILASTATIN
ANDA #207594 |
ORIG-1 |
CILASTATIN SODIUM; IMIPENEM |
HQ SPCLT PHARMA |
|
Approval |
| 12/12/2019 |
XELJANZ XR
NDA #208246 |
SUPPL-9 |
TOFACITINIB CITRATE |
PFIZER |
Efficacy |
Approval |
| 12/12/2019 |
FLUOROURACIL
ANDA #209219 |
ORIG-1 |
FLUOROURACIL |
NOVAST LABS |
|
Approval |
| 12/12/2019 |
VYONDYS 53
NDA #211970 |
ORIG-1 |
GOLODIRSEN |
SAREPTA THERAPS INC |
Type 1 - New Molecular Entity |
Approval |
| 12/12/2019 |
BUMETANIDE
ANDA #212019 |
ORIG-1 |
BUMETANIDE |
RISING |
|
Approval |
| 12/13/2019 |
PARLODEL
NDA #017962 |
SUPPL-81 |
BROMOCRIPTINE MESYLATE |
SS PHARMA |
Labeling |
Approval |
| 12/13/2019 |
DOSTINEX
NDA #020664 |
SUPPL-17 |
CABERGOLINE |
PFIZER |
Labeling |
Approval |
| 12/13/2019 |
ARIXTRA
NDA #021345 |
SUPPL-37 |
FONDAPARINUX SODIUM |
MYLAN IRELAND LTD |
Labeling |
Approval |
| 12/13/2019 |
KUVAN
NDA #022181 |
SUPPL-18 |
SAPROPTERIN DIHYDROCHLORIDE |
BIOMARIN PHARM |
Labeling |
Approval |
| 12/13/2019 |
CETIRIZINE HYDROCHLORIDE ALLERGY
NDA #022429 |
SUPPL-14 |
CETIRIZINE HYDROCHLORIDE |
BIONPHARMA |
Manufacturing (CMC) |
Approval |
| 12/13/2019 |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
NDA #022429 |
SUPPL-14 |
CETIRIZINE HYDROCHLORIDE |
BIONPHARMA |
Manufacturing (CMC) |
Approval |
| 12/13/2019 |
CELLCEPT
NDA #050722 |
SUPPL-40 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
| 12/13/2019 |
CELLCEPT
NDA #050723 |
SUPPL-41 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
| 12/13/2019 |
CELLCEPT
NDA #050758 |
SUPPL-37 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
ROCHE PALO |
Labeling |
Approval |
| 12/13/2019 |
CELLCEPT
NDA #050759 |
SUPPL-45 |
MYCOPHENOLATE MOFETIL |
ROCHE PALO |
Labeling |
Approval |
| 12/13/2019 |
CABERGOLINE
ANDA #076310 |
SUPPL-11 |
CABERGOLINE |
STRIDES PHARMA |
Labeling |
Approval |
| 12/13/2019 |
SERTRALINE HYDROCHLORIDE
ANDA #076671 |
SUPPL-12 |
SERTRALINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 12/13/2019 |
CABERGOLINE
ANDA #077750 |
SUPPL-10 |
CABERGOLINE |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 12/13/2019 |
CABERGOLINE
ANDA #077843 |
SUPPL-4 |
CABERGOLINE |
IMPAX LABS INC |
Labeling |
Approval |
| 12/13/2019 |
CABERGOLINE
ANDA #078035 |
SUPPL-10 |
CABERGOLINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 12/13/2019 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647 |
SUPPL-7 |
TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/13/2019 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647 |
SUPPL-10 |
TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/13/2019 |
LAMIVUDINE AND ZIDOVUDINE
ANDA #090679 |
SUPPL-16 |
LAMIVUDINE; ZIDOVUDINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/13/2019 |
DULOXETINE HYDROCHLORIDE
ANDA #090778 |
SUPPL-20 |
DULOXETINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/13/2019 |
QUININE SULFATE
ANDA #091661 |
SUPPL-7 |
QUININE SULFATE |
TEVA PHARMS |
Labeling |
Approval |
| 12/13/2019 |
MYALEPT
BLA #125390 |
SUPPL-17 |
METRELEPTIN |
AMRYT |
|
Approval |
| 12/13/2019 |
ARMODAFINIL
ANDA #200043 |
SUPPL-6 |
ARMODAFINIL |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
ABACAVIR SULFATE
ANDA #201107 |
SUPPL-7 |
ABACAVIR SULFATE |
HETERO LABS LTD III |
Labeling |
Approval |
| 12/13/2019 |
ABACAVIR SULFATE
ANDA #201107 |
SUPPL-8 |
ABACAVIR SULFATE |
HETERO LABS LTD III |
Labeling |
Approval |
| 12/13/2019 |
VASCEPA
NDA #202057 |
SUPPL-35 |
ICOSAPENT ETHYL |
AMARIN PHARMS |
Efficacy |
Approval |
| 12/13/2019 |
IBANDRONATE SODIUM
ANDA #202235 |
SUPPL-1 |
IBANDRONATE SODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
IBANDRONATE SODIUM
ANDA #202235 |
SUPPL-3 |
IBANDRONATE SODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
IBANDRONATE SODIUM
ANDA #202235 |
SUPPL-4 |
IBANDRONATE SODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CABERGOLINE
ANDA #202947 |
SUPPL-1 |
CABERGOLINE |
MYLAN |
Labeling |
Approval |
| 12/13/2019 |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #203580 |
SUPPL-1 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TORRENT |
Labeling |
Approval |
| 12/13/2019 |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #203580 |
SUPPL-4 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TORRENT |
Labeling |
Approval |
| 12/13/2019 |
QUININE SULFATE
ANDA #203729 |
SUPPL-2 |
QUININE SULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/13/2019 |
AMIKACIN SULFATE
ANDA #204040 |
SUPPL-5 |
AMIKACIN SULFATE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 12/13/2019 |
AMIKACIN SULFATE
ANDA #204040 |
SUPPL-10 |
AMIKACIN SULFATE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 12/13/2019 |
AMIKACIN SULFATE
ANDA #204040 |
SUPPL-14 |
AMIKACIN SULFATE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 12/13/2019 |
CLOPIDOGREL BISULFATE
ANDA #204165 |
SUPPL-7 |
CLOPIDOGREL BISULFATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CLOPIDOGREL BISULFATE
ANDA #204165 |
SUPPL-8 |
CLOPIDOGREL BISULFATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CLOPIDOGREL BISULFATE
ANDA #204165 |
SUPPL-9 |
CLOPIDOGREL BISULFATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CLOPIDOGREL BISULFATE
ANDA #204165 |
SUPPL-12 |
CLOPIDOGREL BISULFATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CLOPIDOGREL BISULFATE
ANDA #204165 |
SUPPL-14 |
CLOPIDOGREL BISULFATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CLOPIDOGREL BISULFATE
ANDA #204165 |
SUPPL-15 |
CLOPIDOGREL BISULFATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/13/2019 |
CABERGOLINE
ANDA #204735 |
SUPPL-1 |
CABERGOLINE |
INGENUS PHARMS LLC |
Labeling |
Approval |
| 12/13/2019 |
KUVAN
NDA #205065 |
SUPPL-7 |
SAPROPTERIN DIHYDROCHLORIDE |
BIOMARIN PHARM |
Labeling |
Approval |
| 12/13/2019 |
CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #206703 |
SUPPL-1 |
CYCLOBENZAPRINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 12/13/2019 |
ZERBAXA
NDA #206829 |
SUPPL-9 |
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM |
CUBIST PHARMS LLC |
Labeling |
Approval |
| 12/13/2019 |
NAPROXEN SODIUM
ANDA #208363 |
SUPPL-3 |
NAPROXEN SODIUM |
PURACAP PHARM LLC |
Labeling |
Approval |
| 12/13/2019 |
DEFERASIROX
ANDA #208697 |
ORIG-1 |
DEFERASIROX |
ACTAVIS ELIZABETH |
|
Approval |
| 12/13/2019 |
FIRVANQ KIT
NDA #208910 |
SUPPL-4 |
VANCOMYCIN HYDROCHLORIDE |
AZURITY |
Labeling |
Approval |
| 12/13/2019 |
TIGLUTIK KIT
NDA #209080 |
SUPPL-1 |
RILUZOLE |
ITALFARMACO SA |
Efficacy |
Approval |
| 12/13/2019 |
DOCETAXEL
ANDA #209634 |
SUPPL-3 |
DOCETAXEL |
MEITHEAL |
Labeling |
Approval |
| 12/13/2019 |
MYCOPHENOLIC SODIUM
ANDA #211173 |
ORIG-1 |
MYCOPHENOLIC SODIUM |
CONCORD BIOTECH LTD |
|
Approval |
| 12/13/2019 |
ZULRESSO
NDA #211371 |
SUPPL-4 |
BREXANOLONE |
SAGE THERAP |
REMS |
Approval |
| 12/13/2019 |
LEVORPHANOL TARTRATE
ANDA #212024 |
ORIG-1 |
LEVORPHANOL TARTRATE |
SPECGX LLC |
|
Approval |
| 12/13/2019 |
NOURESS
NDA #212535 |
ORIG-1 |
CYSTEINE HYDROCHLORIDE |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/13/2019 |
CAPTOPRIL
ANDA #212809 |
ORIG-1 |
CAPTOPRIL |
AJANTA PHARMA LTD |
|
Approval |
| 12/16/2019 |
SURVANTA
BLA #020032 |
SUPPL-45 |
BERACTANT |
ABBVIE |
|
Approval |
| 12/16/2019 |
CUROSURF
BLA #020744 |
SUPPL-40 |
PORACTANT ALFA |
CHIESI USA INC |
|
Approval |
| 12/16/2019 |
VENTOLIN HFA
NDA #020983 |
SUPPL-36 |
ALBUTEROL SULFATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/16/2019 |
LUVOX
NDA #021519 |
SUPPL-12 |
FLUVOXAMINE MALEATE |
ANI PHARMS |
Labeling |
Approval |
| 12/16/2019 |
VENTAVIS
NDA #021779 |
SUPPL-19 |
ILOPROST |
ACTELION |
Labeling |
Approval |
| 12/16/2019 |
CLEOCIN
NDA #050537 |
SUPPL-41 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 12/16/2019 |
CLEOCIN T
NDA #050537 |
SUPPL-41 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 12/16/2019 |
CLEOCIN T
NDA #050600 |
SUPPL-18 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 12/16/2019 |
CLEOCIN T
NDA #050615 |
SUPPL-19 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
| 12/16/2019 |
TOPOTECAN HYDROCHLORIDE
NDA #200582 |
SUPPL-3 |
TOPOTECAN HYDROCHLORIDE |
HOSPIRA INC |
Labeling |
Approval |
| 12/16/2019 |
XTANDI
NDA #203415 |
SUPPL-15 |
ENZALUTAMIDE |
ASTELLAS |
Efficacy |
Approval |
| 12/16/2019 |
ZILEUTON
ANDA #212670 |
ORIG-1 |
ZILEUTON |
STRIDES PHARMA |
|
Approval |
| 12/16/2019 |
CAFFEINE CITRATE
ANDA #213202 |
ORIG-1 |
CAFFEINE CITRATE |
MICRO LABS |
|
Approval |
| 12/17/2019 |
TAXOTERE
NDA #020449 |
SUPPL-83 |
DOCETAXEL |
SANOFI AVENTIS US |
Labeling |
Approval |
| 12/17/2019 |
CLARITHROMYCIN
ANDA #065178 |
SUPPL-14 |
CLARITHROMYCIN |
HIKMA |
Labeling |
Approval |
| 12/17/2019 |
CLARITHROMYCIN
ANDA #065178 |
SUPPL-15 |
CLARITHROMYCIN |
HIKMA |
Labeling |
Approval |
| 12/17/2019 |
CLARITHROMYCIN
ANDA #065178 |
SUPPL-16 |
CLARITHROMYCIN |
HIKMA |
Labeling |
Approval |
| 12/17/2019 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776 |
SUPPL-40 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
CHARTWELL RX |
Labeling |
Approval |
| 12/17/2019 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776 |
SUPPL-42 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
CHARTWELL RX |
Labeling |
Approval |
| 12/17/2019 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776 |
SUPPL-43 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
CHARTWELL RX |
Labeling |
Approval |
| 12/17/2019 |
GLIPIZIDE
ANDA #076467 |
SUPPL-24 |
GLIPIZIDE |
WATSON LABS |
Labeling |
Approval |
| 12/17/2019 |
GLIPIZIDE
ANDA #076467 |
SUPPL-25 |
GLIPIZIDE |
WATSON LABS |
Labeling |
Approval |
| 12/17/2019 |
GLIPIZIDE
ANDA #076467 |
SUPPL-26 |
GLIPIZIDE |
WATSON LABS |
Labeling |
Approval |
| 12/17/2019 |
LIOTHYRONINE SODIUM
ANDA #090097 |
SUPPL-13 |
LIOTHYRONINE SODIUM |
DR REDDYS LABS SA |
Labeling |
Approval |
| 12/17/2019 |
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
ANDA #090145 |
SUPPL-4 |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE |
NOVEL LABS INC |
Labeling |
Approval |
| 12/17/2019 |
CAPECITABINE
ANDA #090943 |
SUPPL-5 |
CAPECITABINE |
RISING |
Labeling |
Approval |
| 12/17/2019 |
CAPECITABINE
ANDA #090943 |
SUPPL-7 |
CAPECITABINE |
RISING |
Labeling |
Approval |
| 12/17/2019 |
CAPECITABINE
ANDA #090943 |
SUPPL-12 |
CAPECITABINE |
RISING |
Labeling |
Approval |
| 12/17/2019 |
CAPECITABINE
ANDA #091649 |
SUPPL-7 |
CAPECITABINE |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/17/2019 |
CAPECITABINE
ANDA #091649 |
SUPPL-10 |
CAPECITABINE |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/17/2019 |
NAGLAZYME
BLA #125117 |
SUPPL-129 |
GALSULFASE |
BIOMARIN |
|
Approval |
| 12/17/2019 |
LAMOTRIGINE
ANDA #201168 |
SUPPL-7 |
LAMOTRIGINE |
ALEMBIC |
Labeling |
Approval |
| 12/17/2019 |
LAMOTRIGINE
ANDA #201168 |
SUPPL-13 |
LAMOTRIGINE |
ALEMBIC |
Labeling |
Approval |
| 12/17/2019 |
LAMOTRIGINE
ANDA #201168 |
SUPPL-14 |
LAMOTRIGINE |
ALEMBIC |
Labeling |
Approval |
| 12/17/2019 |
PARICALCITOL
NDA #201657 |
SUPPL-6 |
PARICALCITOL |
HOSPIRA |
Labeling |
Approval |
| 12/17/2019 |
RYTARY
NDA #203312 |
SUPPL-11 |
CARBIDOPA; LEVODOPA |
IMPAX LABS INC |
Labeling |
Approval |
| 12/17/2019 |
IBANDRONATE SODIUM
ANDA #203987 |
SUPPL-8 |
IBANDRONATE SODIUM |
AVET LIFESCIENCES |
Labeling |
Approval |
| 12/17/2019 |
ARIPIPRAZOLE
ANDA #204094 |
SUPPL-5 |
ARIPIPRAZOLE |
APOTEX |
Labeling |
Approval |
| 12/17/2019 |
ARIPIPRAZOLE
ANDA #204094 |
SUPPL-7 |
ARIPIPRAZOLE |
APOTEX |
Labeling |
Approval |
| 12/17/2019 |
IBANDRONATE SODIUM
ANDA #204222 |
SUPPL-1 |
IBANDRONATE SODIUM |
APOTEX |
Labeling |
Approval |
| 12/17/2019 |
RAYALDEE
NDA #208010 |
SUPPL-5 |
CALCIFEDIOL |
EIRGEN |
Labeling |
Approval |
| 12/17/2019 |
OXYBUTYNIN CHLORIDE
ANDA #210717 |
ORIG-1 |
OXYBUTYNIN CHLORIDE |
BIONPHARMA |
|
Approval |
| 12/17/2019 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #210817 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
DR REDDYS LABS SA |
|
Approval |
| 12/17/2019 |
DOFETILIDE
ANDA #211223 |
ORIG-1 |
DOFETILIDE |
PRINSTON INC |
|
Approval |
| 12/17/2019 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #212082 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
LANNETT CO INC |
|
Approval |
| 12/17/2019 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #212083 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
LANNETT CO INC |
|
Approval |
| 12/18/2019 |
DROXIA
NDA #016295 |
SUPPL-52 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 12/18/2019 |
HYDREA
NDA #016295 |
SUPPL-52 |
HYDROXYUREA |
CHEPLAPHARM |
Labeling |
Approval |
| 12/18/2019 |
SYMLIN
NDA #021332 |
SUPPL-28 |
PRAMLINTIDE ACETATE |
ASTRAZENECA AB |
Labeling |
Approval |
| 12/18/2019 |
CADUET
NDA #021540 |
SUPPL-45 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
PHARMACIA |
Labeling |
Approval |
| 12/18/2019 |
DUAVEE
NDA #022247 |
SUPPL-6 |
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED |
WYETH PHARMS |
Labeling |
Approval |
| 12/18/2019 |
FAMOTIDINE
ANDA #075512 |
SUPPL-17 |
FAMOTIDINE |
P AND L |
Labeling |
Approval |
| 12/18/2019 |
FAMOTIDINE
ANDA #075512 |
SUPPL-20 |
FAMOTIDINE |
P AND L |
Labeling |
Approval |
| 12/18/2019 |
OXALIPLATIN
ANDA #078811 |
SUPPL-14 |
OXALIPLATIN |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/18/2019 |
LEUCOVORIN CALCIUM
ANDA #089717 |
SUPPL-31 |
LEUCOVORIN CALCIUM |
HIKMA |
Labeling |
Approval |
| 12/18/2019 |
KEPIVANCE
BLA #125103 |
SUPPL-176 |
PALIFERMIN |
BIOVITRUM AB |
|
Approval |
| 12/18/2019 |
SITAVIG
NDA #203791 |
SUPPL-1 |
ACYCLOVIR |
LNHC |
Labeling |
Approval |
| 12/18/2019 |
HEMANGEOL
NDA #205410 |
SUPPL-3 |
PROPRANOLOL HYDROCHLORIDE |
PIERRE FABRE DERMA |
Labeling |
Approval |
| 12/18/2019 |
TICAGRELOR
ANDA #208531 |
SUPPL-3 |
TICAGRELOR |
AMNEAL |
Labeling |
Approval |
| 12/18/2019 |
BETAMETHASONE DIPROPIONATE
ANDA #209106 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE |
LUPIN LTD |
|
Approval |
| 12/18/2019 |
ARAZLO
NDA #211882 |
ORIG-1 |
TAZAROTENE |
BAUSCH |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/18/2019 |
TRUXIMA
BLA #761088 |
SUPPL-5 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
| 12/18/2019 |
TRUXIMA
BLA #761088 |
SUPPL-6 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
| 12/18/2019 |
PADCEV
BLA #761137 |
ORIG-1 |
ENFORTUMAB VEDOTIN-EJFV |
ASTELLAS |
|
Approval |
| 12/19/2019 |
AN-SULFUR COLLOID
NDA #017858 |
SUPPL-49 |
TECHNETIUM TC-99M SULFUR COLLOID KIT |
SUN PHARM INDS INC |
Labeling |
Approval |
| 12/19/2019 |
NORVIR
NDA #020659 |
SUPPL-71 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
NORVIR
NDA #020945 |
SUPPL-47 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
ASMANEX TWISTHALER
NDA #021067 |
SUPPL-29 |
MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
| 12/19/2019 |
KALETRA
NDA #021226 |
SUPPL-48 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
KALETRA
NDA #021251 |
SUPPL-58 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
ENTEREG
NDA #021775 |
SUPPL-15 |
ALVIMOPAN |
CUBIST PHARMS |
REMS |
Approval |
| 12/19/2019 |
INVIRASE
NDA #021785 |
SUPPL-24 |
SAQUINAVIR MESYLATE |
HOFFMANN-LA ROCHE |
Labeling |
Approval |
| 12/19/2019 |
KALETRA
NDA #021906 |
SUPPL-53 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
AMPYRA
NDA #022250 |
SUPPL-17 |
DALFAMPRIDINE |
ACORDA |
Labeling |
Approval |
| 12/19/2019 |
NORVIR
NDA #022417 |
SUPPL-23 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
GABLOFEN
NDA #022462 |
SUPPL-11 |
BACLOFEN |
PIRAMAL CRITICAL |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065069 |
SUPPL-15 |
CEFUROXIME AXETIL |
APOTEX |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065069 |
SUPPL-16 |
CEFUROXIME AXETIL |
APOTEX |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065135 |
SUPPL-22 |
CEFUROXIME AXETIL |
LUPIN |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065135 |
SUPPL-24 |
CEFUROXIME AXETIL |
LUPIN |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065308 |
SUPPL-13 |
CEFUROXIME AXETIL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065308 |
SUPPL-15 |
CEFUROXIME AXETIL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065308 |
SUPPL-16 |
CEFUROXIME AXETIL |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065496 |
SUPPL-10 |
CEFUROXIME AXETIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 12/19/2019 |
CEFUROXIME AXETIL
ANDA #065496 |
SUPPL-12 |
CEFUROXIME AXETIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 12/19/2019 |
DONEPEZIL HYDROCHLORIDE
ANDA #091198 |
SUPPL-9 |
DONEPEZIL HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 12/19/2019 |
OXALIPLATIN
ANDA #203869 |
SUPPL-1 |
OXALIPLATIN |
HENGRUI PHARMA |
Labeling |
Approval |
| 12/19/2019 |
MINOCYCLINE HYDROCHLORIDE
ANDA #204453 |
ORIG-3 |
MINOCYCLINE HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
| 12/19/2019 |
TAGRISSO
NDA #208065 |
SUPPL-13 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Labeling |
Approval |
| 12/19/2019 |
ALVIMOPAN
ANDA #208295 |
ORIG-1 |
ALVIMOPAN |
WATSON LABS TEVA |
|
Approval |
| 12/19/2019 |
LINAGLIPTIN
ANDA #208455 |
ORIG-1 |
LINAGLIPTIN |
SUN PHARMA GLOBAL |
|
Tentative Approval |
| 12/19/2019 |
FIASP
BLA #208751 |
SUPPL-10 |
INSULIN ASPART |
NOVO |
|
Approval |
| 12/19/2019 |
FIASP
BLA #208751 |
SUPPL-11 |
INSULIN ASPART |
NOVO |
|
Approval |
| 12/19/2019 |
FIASP FLEXTOUCH
BLA #208751 |
SUPPL-10 |
INSULIN ASPART |
NOVO |
|
Approval |
| 12/19/2019 |
FIASP FLEXTOUCH
BLA #208751 |
SUPPL-11 |
INSULIN ASPART |
NOVO |
|
Approval |
| 12/19/2019 |
FIASP PENFILL
BLA #208751 |
SUPPL-10 |
INSULIN ASPART |
NOVO |
|
Approval |
| 12/19/2019 |
FIASP PENFILL
BLA #208751 |
SUPPL-11 |
INSULIN ASPART |
NOVO |
|
Approval |
| 12/19/2019 |
NORVIR
NDA #209512 |
SUPPL-6 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
| 12/19/2019 |
CONJUPRI
NDA #212895 |
ORIG-1 |
LEVAMLODIPINE MALEATE |
CSPC OUYI |
Type 2 - New Active Ingredient and Type 3 - New Dosage Form |
Approval |
| 12/19/2019 |
RITUXAN HYCELA
BLA #761064 |
SUPPL-9 |
RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
GENENTECH INC |
|
Approval |
| 12/20/2019 |
MYCAMINE
NDA #021506 |
SUPPL-23 |
MICAFUNGIN SODIUM |
ASTELLAS |
Efficacy |
Approval |
| 12/20/2019 |
CLOLAR
NDA #021673 |
SUPPL-26 |
CLOFARABINE |
GENZYME |
Labeling |
Approval |
| 12/20/2019 |
VIBRAMYCIN
NDA #050006 |
SUPPL-92 |
DOXYCYCLINE |
PFIZER |
Labeling |
Approval |
| 12/20/2019 |
VIBRAMYCIN
NDA #050007 |
SUPPL-34 |
DOXYCYCLINE HYCLATE |
PFIZER |
Labeling |
Approval |
| 12/20/2019 |
DOXORUBICIN HYDROCHLORIDE
NDA #050467 |
SUPPL-76 |
DOXORUBICIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 12/20/2019 |
VIBRAMYCIN
NDA #050480 |
SUPPL-58 |
DOXYCYCLINE CALCIUM |
PFIZER |
Labeling |
Approval |
| 12/20/2019 |
VIBRA-TABS
NDA #050533 |
SUPPL-47 |
DOXYCYCLINE HYCLATE |
PFIZER |
Labeling |
Approval |
| 12/20/2019 |
DOXORUBICIN HYDROCHLORIDE
NDA #050629 |
SUPPL-28 |
DOXORUBICIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
| 12/20/2019 |
GLIPIZIDE
ANDA #074387 |
SUPPL-4 |
GLIPIZIDE |
ANI PHARMS |
Labeling |
Approval |
| 12/20/2019 |
GLIPIZIDE
ANDA #074497 |
SUPPL-28 |
GLIPIZIDE |
ANI PHARMS |
Labeling |
Approval |
| 12/20/2019 |
GLIPIZIDE
ANDA #074497 |
SUPPL-29 |
GLIPIZIDE |
ANI PHARMS |
Labeling |
Approval |
| 12/20/2019 |
LEVALBUTEROL HYDROCHLORIDE
ANDA #078171 |
SUPPL-5 |
LEVALBUTEROL HYDROCHLORIDE |
CIPLA |
Labeling |
Approval |
| 12/20/2019 |
ESZOPICLONE
ANDA #091024 |
SUPPL-3 |
ESZOPICLONE |
DR REDDYS |
Labeling |
Approval |
| 12/20/2019 |
ESZOPICLONE
ANDA #091024 |
SUPPL-4 |
ESZOPICLONE |
DR REDDYS |
Labeling |
Approval |
| 12/20/2019 |
ESZOPICLONE
ANDA #091024 |
SUPPL-5 |
ESZOPICLONE |
DR REDDYS |
Labeling |
Approval |
| 12/20/2019 |
AMYVID
NDA #202008 |
SUPPL-36 |
FLORBETAPIR F-18 |
AVID RADIOPHARMS INC |
Labeling |
Approval |
| 12/20/2019 |
GENOSYL
NDA #202860 |
ORIG-1 |
NITRIC OXIDE |
VERO BIOTECH INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/20/2019 |
JUXTAPID
NDA #203858 |
SUPPL-19 |
LOMITAPIDE MESYLATE |
CHIESI |
Labeling |
Approval |
| 12/20/2019 |
QUETIAPINE FUMARATE
ANDA #204253 |
SUPPL-6 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/20/2019 |
QUETIAPINE FUMARATE
ANDA #204253 |
SUPPL-10 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/20/2019 |
ONZETRA XSAIL
NDA #206099 |
SUPPL-6 |
SUMATRIPTAN SUCCINATE |
CURRAX |
Labeling |
Approval |
| 12/20/2019 |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #206137 |
SUPPL-1 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/20/2019 |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #206137 |
SUPPL-3 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/20/2019 |
ZOLMITRIPTAN
ANDA #207021 |
SUPPL-2 |
ZOLMITRIPTAN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/20/2019 |
QUETIAPINE FUMARATE
ANDA #207655 |
SUPPL-2 |
QUETIAPINE FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/20/2019 |
QUETIAPINE FUMARATE
ANDA #207655 |
SUPPL-4 |
QUETIAPINE FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/20/2019 |
LEVALBUTEROL HYDROCHLORIDE
ANDA #207820 |
SUPPL-2 |
LEVALBUTEROL HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 12/20/2019 |
OSELTAMIVIR PHOSPHATE
ANDA #208347 |
SUPPL-1 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
Labeling |
Approval |
| 12/20/2019 |
OSELTAMIVIR PHOSPHATE
ANDA #208347 |
SUPPL-4 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
Labeling |
Approval |
| 12/20/2019 |
OSELTAMIVIR PHOSPHATE
ANDA #208347 |
SUPPL-5 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
Labeling |
Approval |
| 12/20/2019 |
CAPECITABINE
ANDA #209365 |
SUPPL-2 |
CAPECITABINE |
MSN |
Labeling |
Approval |
| 12/20/2019 |
CAPLYTA
NDA #209500 |
ORIG-1 |
LUMATEPERONE TOSYLATE |
INTRA-CELLULAR |
Type 1 - New Molecular Entity |
Approval |
| 12/20/2019 |
CAPLYTA
NDA #209500 |
SUPPL-1 |
LUMATEPERONE TOSYLATE |
INTRA-CELLULAR |
Type 1 - New Molecular Entity |
Approval |
| 12/20/2019 |
TISSUEBLUE
NDA #209569 |
ORIG-1 |
BRILLIANT BLUE G |
DUTCH OPHTHALMIC |
Type 1 - New Molecular Entity |
Approval |
| 12/20/2019 |
PREVYMIS
NDA #209939 |
SUPPL-6 |
LETERMOVIR |
MERCK SHARP DOHME |
Labeling |
Approval |
| 12/20/2019 |
PREVYMIS
NDA #209940 |
SUPPL-4 |
LETERMOVIR |
MERCK SHARP DOHME |
Labeling |
Approval |
| 12/20/2019 |
TRAVOPROST
ANDA #210458 |
ORIG-1 |
TRAVOPROST |
ALEMBIC |
|
Approval |
| 12/20/2019 |
DIAZOXIDE
ANDA #211050 |
ORIG-1 |
DIAZOXIDE |
E5 PHARMA INC |
|
Approval |
| 12/20/2019 |
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ANDA #211190 |
ORIG-1 |
DEXTROSE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 12/20/2019 |
PANTOPRAZOLE SODIUM
ANDA #211368 |
SUPPL-2 |
PANTOPRAZOLE SODIUM |
INGENUS PHARMS LLC |
Labeling |
Approval |
| 12/20/2019 |
DAYVIGO
NDA #212028 |
ORIG-1 |
LEMBOREXANT |
EISAI INC |
Type 1 - New Molecular Entity |
Approval |
| 12/20/2019 |
EVENITY
BLA #761062 |
SUPPL-2 |
ROMOSOZUMAB-AQQG |
AMGEN INC |
|
Approval |
| 12/20/2019 |
ENHERTU
BLA #761139 |
ORIG-1 |
FAM-TRASTUZUMAB DERUXTECAN-NXKI |
DAIICHI SANKYO |
|
Approval |
| 12/22/2019 |
RISPERIDONE
ANDA #090839 |
SUPPL-8 |
RISPERIDONE |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/22/2019 |
RISPERIDONE
ANDA #090839 |
SUPPL-9 |
RISPERIDONE |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/22/2019 |
RISPERIDONE
ANDA #090839 |
SUPPL-13 |
RISPERIDONE |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/23/2019 |
DEPO-SUBQ PROVERA 104
NDA #021583 |
SUPPL-16 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 12/23/2019 |
DEPO-SUBQ PROVERA 104
NDA #021583 |
SUPPL-24 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 12/23/2019 |
DEPO-SUBQ PROVERA 104
NDA #021583 |
SUPPL-29 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 12/23/2019 |
CARBAGLU
NDA #022562 |
SUPPL-11 |
CARGLUMIC ACID |
RECORDATI RARE |
Labeling |
Approval |
| 12/23/2019 |
AZITHROMYCIN
ANDA #065400 |
SUPPL-5 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 12/23/2019 |
AZITHROMYCIN
ANDA #065400 |
SUPPL-10 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #074118 |
SUPPL-10 |
PIROXICAM |
NOSTRUM LABS INC |
Labeling |
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #074118 |
SUPPL-12 |
PIROXICAM |
NOSTRUM LABS INC |
Labeling |
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #074131 |
SUPPL-20 |
PIROXICAM |
TEVA |
Labeling |
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #074131 |
SUPPL-22 |
PIROXICAM |
TEVA |
Labeling |
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #074131 |
SUPPL-24 |
PIROXICAM |
TEVA |
Labeling |
Approval |
| 12/23/2019 |
HALOPERIDOL DECANOATE
ANDA #075440 |
SUPPL-40 |
HALOPERIDOL DECANOATE |
MYLAN LABS LTD |
Labeling |
Approval |
| 12/23/2019 |
HALOPERIDOL DECANOATE
ANDA #075440 |
SUPPL-41 |
HALOPERIDOL DECANOATE |
MYLAN LABS LTD |
Labeling |
Approval |
| 12/23/2019 |
HALOPERIDOL DECANOATE
ANDA #075440 |
SUPPL-45 |
HALOPERIDOL DECANOATE |
MYLAN LABS LTD |
Labeling |
Approval |
| 12/23/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #200294 |
SUPPL-3 |
MECLIZINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 12/23/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #200294 |
SUPPL-5 |
MECLIZINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 12/23/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #200294 |
SUPPL-6 |
MECLIZINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 12/23/2019 |
LIOTHYRONINE SODIUM
ANDA #200295 |
SUPPL-5 |
LIOTHYRONINE SODIUM |
SIGMAPHARM LABS LLC |
Labeling |
Approval |
| 12/23/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #202640 |
SUPPL-2 |
MECLIZINE HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 12/23/2019 |
MECLIZINE HYDROCHLORIDE
ANDA #202640 |
SUPPL-3 |
MECLIZINE HYDROCHLORIDE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 12/23/2019 |
METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #202691 |
SUPPL-1 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
HIKMA |
Labeling |
Approval |
| 12/23/2019 |
METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #202691 |
SUPPL-2 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
HIKMA |
Labeling |
Approval |
| 12/23/2019 |
GATIFLOXACIN
ANDA #204227 |
SUPPL-1 |
GATIFLOXACIN |
SANDOZ |
Labeling |
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #206136 |
SUPPL-4 |
PIROXICAM |
STRIDES PHARMA |
Labeling |
Approval |
| 12/23/2019 |
ZILRETTA
NDA #208845 |
SUPPL-7 |
TRIAMCINOLONE ACETONIDE |
PACIRA PHARMS INC |
Efficacy |
Approval |
| 12/23/2019 |
ALOGLIPTIN
ANDA #210002 |
ORIG-1 |
ALOGLIPTIN BENZOATE |
INDOCO REMEDIES |
|
Tentative Approval |
| 12/23/2019 |
APIXABAN
ANDA #210013 |
ORIG-1 |
APIXABAN |
MICRO LABS |
|
Approval |
| 12/23/2019 |
APIXABAN
ANDA #210128 |
ORIG-1 |
APIXABAN |
MYLAN |
|
Approval |
| 12/23/2019 |
PIROXICAM
ANDA #210347 |
SUPPL-2 |
PIROXICAM |
STRIDES PHARMA |
Labeling |
Approval |
| 12/23/2019 |
LORATADINE
ANDA #210722 |
ORIG-1 |
LORATADINE |
GRANULES |
|
Approval |
| 12/23/2019 |
PENICILLAMINE
ANDA #211196 |
ORIG-1 |
PENICILLAMINE |
ENDO OPERATIONS |
|
Approval |
| 12/23/2019 |
PENICILLAMINE
ANDA #211231 |
ORIG-1 |
PENICILLAMINE |
ENDO OPERATIONS |
|
Approval |
| 12/23/2019 |
LIOTHYRONINE SODIUM
ANDA #211510 |
SUPPL-1 |
LIOTHYRONINE SODIUM |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/23/2019 |
UBRELVY
NDA #211765 |
ORIG-1 |
UBROGEPANT |
ABBVIE |
Type 1 - New Molecular Entity |
Approval |
| 12/23/2019 |
CYTARABINE
ANDA #211937 |
ORIG-1 |
CYTARABINE |
GLAND PHARMA LTD |
|
Approval |
| 12/23/2019 |
CYTARABINE
ANDA #211938 |
ORIG-1 |
CYTARABINE |
GLAND PHARMA LTD |
|
Approval |
| 12/26/2019 |
XOLEGEL
NDA #021946 |
SUPPL-7 |
KETOCONAZOLE |
ALMIRALL |
Labeling |
Approval |
| 12/26/2019 |
STAVZOR
NDA #022152 |
SUPPL-8 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
| 12/26/2019 |
SUMAVEL DOSEPRO
NDA #022239 |
SUPPL-6 |
SUMATRIPTAN SUCCINATE |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/26/2019 |
GILENYA
NDA #022527 |
SUPPL-31 |
FINGOLIMOD HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 12/26/2019 |
OTREXUP
NDA #204824 |
SUPPL-10 |
METHOTREXATE |
OTTER PHARMS |
Labeling |
Approval |
| 12/26/2019 |
OTREXUP PFS
NDA #204824 |
SUPPL-10 |
METHOTREXATE |
OTTER PHARMS |
Labeling |
Approval |
| 12/26/2019 |
ACTICLATE
NDA #205931 |
SUPPL-4 |
DOXYCYCLINE HYCLATE |
CHARTWELL RX |
Labeling |
Approval |
| 12/26/2019 |
TOBRAMYCIN
ANDA #207136 |
ORIG-1 |
TOBRAMYCIN |
SUN PHARM |
|
Approval |
| 12/26/2019 |
ACTICLATE CAP
NDA #208253 |
SUPPL-2 |
DOXYCYCLINE HYCLATE |
CHARTWELL RX |
Labeling |
Approval |
| 12/26/2019 |
PREGABALIN
ANDA #210585 |
ORIG-1 |
PREGABALIN |
RENATA |
|
Approval |
| 12/26/2019 |
ZIPRASIDONE MESYLATE
ANDA #211908 |
ORIG-1 |
ZIPRASIDONE MESYLATE |
GLAND PHARMA LTD |
|
Approval |
| 12/26/2019 |
DIAZEPAM
ANDA #211998 |
ORIG-1 |
DIAZEPAM |
BELOTECA |
|
Approval |
| 12/26/2019 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #212234 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
AJANTA PHARMA LTD |
|
Approval |
| 12/26/2019 |
ARIPIPRAZOLE
ANDA #212870 |
ORIG-1 |
ARIPIPRAZOLE |
VISTAPHARM |
|
Approval |
| 12/27/2019 |
COPAXONE
NDA #020622 |
SUPPL-107 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/27/2019 |
LEVEMIR
BLA #021536 |
SUPPL-56 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 12/27/2019 |
LEVEMIR FLEXPEN
BLA #021536 |
SUPPL-56 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 12/27/2019 |
LEVEMIR FLEXTOUCH
BLA #021536 |
SUPPL-56 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 12/27/2019 |
LEVEMIR INNOLET
BLA #021536 |
SUPPL-56 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 12/27/2019 |
LEVEMIR PENFILL
BLA #021536 |
SUPPL-56 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 12/27/2019 |
INTUNIV
NDA #022037 |
SUPPL-19 |
GUANFACINE HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/27/2019 |
ZIDOVUDINE
NDA #200732 |
SUPPL-2 |
ZIDOVUDINE |
MYLAN LABS LTD |
Labeling |
Approval |
| 12/27/2019 |
RAYOS
NDA #202020 |
SUPPL-12 |
PREDNISONE |
HORIZON |
Labeling |
Approval |
| 12/27/2019 |
NICOTINE POLACRILEX
ANDA #203690 |
SUPPL-22 |
NICOTINE POLACRILEX |
PERRIGO R AND D |
Manufacturing (CMC) |
Approval |
| 12/27/2019 |
TEPADINA
NDA #208264 |
SUPPL-1 |
THIOTEPA |
ADIENNE SA |
Labeling |
Approval |
| 12/27/2019 |
LYNPARZA
NDA #208558 |
SUPPL-10 |
OLAPARIB |
ASTRAZENECA |
Efficacy |
Approval |
| 12/27/2019 |
MIRABEGRON
ANDA #209446 |
ORIG-1 |
MIRABEGRON |
SAWAI USA |
|
Approval |
| 12/27/2019 |
SYMDEKO (COPACKAGED)
NDA #210491 |
SUPPL-5 |
IVACAFTOR; IVACAFTOR, TEZACAFTOR |
VERTEX PHARMS INC |
Labeling |
Approval |
| 12/27/2019 |
DEFERASIROX
ANDA #210727 |
ORIG-1 |
DEFERASIROX |
STEVENS J |
|
Approval |
| 12/27/2019 |
DOFETILIDE
ANDA #212410 |
ORIG-1 |
DOFETILIDE |
NOVAST LABS |
|
Approval |
| 12/28/2019 |
NYMALIZE
NDA #203340 |
SUPPL-12 |
NIMODIPINE |
AZURITY |
Labeling |
Approval |
| 12/30/2019 |
STALEVO 100
NDA #021485 |
SUPPL-42 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
ORION PHARMA |
Labeling |
Approval |
| 12/30/2019 |
STALEVO 125
NDA #021485 |
SUPPL-42 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
ORION PHARMA |
Labeling |
Approval |
| 12/30/2019 |
STALEVO 150
NDA #021485 |
SUPPL-42 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
ORION PHARMA |
Labeling |
Approval |
| 12/30/2019 |
STALEVO 200
NDA #021485 |
SUPPL-42 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
ORION PHARMA |
Labeling |
Approval |
| 12/30/2019 |
STALEVO 50
NDA #021485 |
SUPPL-42 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
ORION PHARMA |
Labeling |
Approval |
| 12/30/2019 |
STALEVO 75
NDA #021485 |
SUPPL-42 |
CARBIDOPA; ENTACAPONE; LEVODOPA |
ORION PHARMA |
Labeling |
Approval |
| 12/30/2019 |
CEFOXITIN
ANDA #065238 |
SUPPL-3 |
CEFOXITIN SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 12/30/2019 |
CEFOXITIN
ANDA #065238 |
SUPPL-5 |
CEFOXITIN SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 12/30/2019 |
CEFOXITIN
ANDA #065238 |
SUPPL-7 |
CEFOXITIN SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 12/30/2019 |
DONEPEZIL HYDROCHLORIDE
ANDA #205269 |
SUPPL-1 |
DONEPEZIL HYDROCHLORIDE |
HISUN PHARM HANGZHOU |
Labeling |
Approval |
| 12/30/2019 |
FEBUXOSTAT
ANDA #210292 |
ORIG-1 |
FEBUXOSTAT |
INDOCO |
|
Approval |
| 12/30/2019 |
FEBUXOSTAT
ANDA #210461 |
ORIG-1 |
FEBUXOSTAT |
MSN |
|
Approval |
| 12/30/2019 |
TOLTERODINE TARTRATE
ANDA #210775 |
ORIG-1 |
TOLTERODINE TARTRATE |
ELYSIUM |
|
Approval |
| 12/30/2019 |
CLOBETASOL PROPIONATE
ANDA #211836 |
ORIG-1 |
CLOBETASOL PROPIONATE |
TORRENT |
|
Approval |
| 12/30/2019 |
BUPIVACAINE HYDROCHLORIDE
ANDA #212822 |
ORIG-1 |
BUPIVACAINE HYDROCHLORIDE |
HUONS |
|
Approval |
| 12/30/2019 |
DEFERASIROX
ANDA #212995 |
ORIG-1 |
DEFERASIROX |
PIRAMAL HLTHCARE UK |
|
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #074112 |
SUPPL-31 |
ALPRAZOLAM |
SANDOZ |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #074174 |
SUPPL-7 |
ALPRAZOLAM |
NOVITIUM PHARMA |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #074215 |
SUPPL-24 |
ALPRAZOLAM |
MYLAN |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #074342 |
SUPPL-47 |
ALPRAZOLAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #074909 |
SUPPL-25 |
ALPRAZOLAM |
SANDOZ |
Labeling |
Approval |
| 12/31/2019 |
ANAGRELIDE HYDROCHLORIDE
ANDA #076683 |
SUPPL-8 |
ANAGRELIDE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #077741 |
SUPPL-3 |
ALPRAZOLAM |
APOTEX INC |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #078491 |
SUPPL-13 |
ALPRAZOLAM |
OXFORD PHARMS |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #090248 |
SUPPL-5 |
ALPRAZOLAM |
STRIDES PHARMA |
Labeling |
Approval |
| 12/31/2019 |
MYCOPHENOLIC SODIUM
ANDA #091558 |
SUPPL-8 |
MYCOPHENOLIC SODIUM |
APOTEX INC |
Labeling |
Approval |
| 12/31/2019 |
ALPRAZOLAM
ANDA #203346 |
SUPPL-2 |
ALPRAZOLAM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/31/2019 |
MOXIFLOXACIN HYDROCHLORIDE
ANDA #204079 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 12/31/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #211983 |
SUPPL-3 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PERRIGO R AND D |
Manufacturing (CMC) |
Approval |
