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FDA ANDA · ANDA077767

GALANTAMINE HYDROBROMIDE

Sponsor: WATSON LABS

APPLICATION
ANDA077767
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

GALANTAMINE HYDROBROMIDENone (Tentative Approval)
GALANTAMINE HYDROBROMIDE EQ 12MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDENone (Tentative Approval)
GALANTAMINE HYDROBROMIDE EQ 4MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDENone (Tentative Approval)
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · TABLET · ORAL

Approval history

2007-03-30OriginalTA
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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