← FDA DRUG APPROVALS

FDA ANDA · ANDA077585

GALANTAMINE HYDROBROMIDE

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA077585
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-15
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 12MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 4MG BASE · TABLET · ORAL

Approval history

2024-11-22Labeling · Supplement 6 · standardAP
2009-09-15OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →