Registrants (1)
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
918596198
Products (3)
galantamine
68382-179
ANDA078898
ANDA (C73584)
ORAL
November 9, 2022
GalantamineActive
Code: MJ4PTD2VVWClass: ACTIMQuantity: 12 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
galantamine
68382-178
ANDA078898
ANDA (C73584)
ORAL
November 9, 2022
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GalantamineActive
Code: MJ4PTD2VVWClass: ACTIMQuantity: 8 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
galantamine
68382-177
ANDA078898
ANDA (C73584)
ORAL
November 9, 2022
GalantamineActive
Code: MJ4PTD2VVWClass: ACTIMQuantity: 4 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT