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FDA Approval

Galantamine hydrobromide

CompanyAphena Pharma Solutions - Tennessee, LLC (DUNS: 128385585)

Effective Date

June 13, 2016

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Galantamine(16 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Labeler

Aphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

Products (1)

Galantamine hydrobromide

NDC Product Code

43353-984

Application Number

ANDA079028

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 15, 2014

Ingredients

GalantamineActive

Code: MJ4PTD2VVWClass: ACTIMQuantity: 16 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

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