← FDA DRUG APPROVALS

FDA ANDA · ANDA090247

DONEPEZIL HYDROCHLORIDE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA090247
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-31
LATEST ACTION
2021-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 5MG · TABLET · ORAL
DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2021-04-14Labeling · Supplement 3 · standardAP
2011-05-31OriginalAP
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 →