← FDA DRUG APPROVALS

FDA ANDA · ANDA074428

CIMETIDINE HYDROCHLORIDE

Sponsor: PH HEALTH

APPLICATION
ANDA074428
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-25
LATEST ACTION
2001-08-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CIMETIDINE HYDROCHLORIDEDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/2ML · INJECTABLE · INJECTION

Approval history

2001-08-27Manufacturing (CMC) · Supplement 2AP
1997-10-20Manufacturing (CMC) · Supplement 1AP
1996-04-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →