MedPath
FDA Approval

Galantamine Hydrobromide

October 26, 2023

Human Prescription Drug Label

Galantamine(8 mg in 1 1)

Manufacturing Establishments (1)

Sun Pharmaceutical Industries Limited

Sun Pharmaceutical Industries, Inc.

650445203

Products (3)

Galantamine Hydrobromide

47335-835

ANDA090178

ANDA (C73584)

ORAL

October 26, 2023

Code: MJ4PTD2VVWClass: ACTIMQuantity: 8 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Galantamine Hydrobromide

47335-836

ANDA090178

ANDA (C73584)

ORAL

October 26, 2023

Code: MJ4PTD2VVWClass: ACTIMQuantity: 16 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Galantamine Hydrobromide

47335-837

ANDA090178

ANDA (C73584)

ORAL

October 26, 2023

STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Code: MJ4PTD2VVWClass: ACTIMQuantity: 24 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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