← FDA DRUG APPROVALS

FDA ANDA · ANDA073443

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: WATSON LABS

APPLICATION
ANDA073443
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-17
LATEST ACTION
2016-12-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
MEPERIDINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2016-12-16Labeling · Supplement 8 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 7AP
1999-02-02Manufacturing (CMC) · Supplement 4AP
1995-07-12Manufacturing (CMC) · Supplement 2AP
1994-09-27Labeling · Supplement 1AP
1992-03-17OriginalAP
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 →