08/01/2017 |
IDHIFA NDA #209606 |
ENASIDENIB MESYLATE |
Type 1 - New Molecular Entity |
Priority |
BRISTOL MYERS SQUIBB |
08/02/2017 |
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE NDA #209670 |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
Type 4 - New Combination |
Priority |
MYLAN PHARMS INC |
08/03/2017 |
QVAR REDIHALER NDA #207921 |
BECLOMETHASONE DIPROPIONATE |
Type 5 - New Formulation or New Manufacturer |
Standard |
NORTON WATERFORD |
08/03/2017 |
MAVYRET NDA #209394 |
GLECAPREVIR; PIBRENTASVIR |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Priority |
ABBVIE |
08/03/2017 |
VYXEOS NDA #209401 |
CYTARABINE; DAUNORUBICIN |
Type 4 - New Combination |
Priority |
CELATOR PHARMS |
08/03/2017 |
GEMCITABINE HYDROCHLORIDE NDA #209604 |
GEMCITABINE HYDROCHLORIDE |
Type 5 - New Formulation or New Manufacturer |
Standard |
ACCORD HLTHCARE |
08/04/2017 |
CAROSPIR NDA #209478 |
SPIRONOLACTONE |
Type 3 - New Dosage Form |
Standard |
CMP DEV LLC |
08/04/2017 |
NIKITA NDA #209875 |
PITAVASTATIN SODIUM |
Type 2 - New Active Ingredient |
Standard |
LUPIN LTD |
08/17/2017 |
LYNPARZA NDA #208558 |
OLAPARIB |
Type 3 - New Dosage Form |
Priority |
ASTRAZENECA |
08/17/2017 |
DRAX EXAMETAZIME NDA #208870 |
TECHNETIUM TC-99M EXAMETAZIME KIT |
Type 5 - New Formulation or New Manufacturer |
Standard |
JUBILANT |
08/17/2017 |
BESPONSA BLA #761040 |
INOTUZUMAB OZOGAMICIN |
|
|
WYETH PHARMS INC |
08/18/2017 |
DUZALLO NDA #209203 |
ALLOPURINOL; LESINURAD |
Type 4 - New Combination |
Standard |
IRONWOOD PHARMS INC |
08/18/2017 |
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE NDA #209618 |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
Type 4 - New Combination |
Priority |
AUROBINDO PHARMA LTD |
08/22/2017 |
CARBON DIOXIDE, USP NDA #210816 |
CARBON DIOXIDE |
Medical Gas |
Unknown |
LISS AMERICA LLC |
08/24/2017 |
GOCOVRI NDA #208944 |
AMANTADINE HYDROCHLORIDE |
Type 3 - New Dosage Form |
Standard |
ADAMAS OPERATIONS |
08/25/2017 |
CYLTEZO BLA #761058 |
ADALIMUMAB-ADBM |
|
|
BOEHRINGER INGELHEIM |
08/29/2017 |
BENZNIDAZOLE NDA #209570 |
BENZNIDAZOLE |
Type 1 - New Molecular Entity |
Priority |
CHEMO RESEARCH SL |
08/29/2017 |
VABOMERE NDA #209776 |
MEROPENEM; VABORBACTAM |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Priority |
REMPEX |
08/30/2017 |
AUSTEDO NDA #209885 |
DEUTETRABENAZINE |
Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval |
Priority |
TEVA BRANDED PHARM |