← FDA DRUG APPROVALS

FDA ANDA · ANDA088432

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: ICU MEDICAL INC

APPLICATION
ANDA088432
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-16
LATEST ACTION
2016-12-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE · ReferenceDiscontinued
MEPERIDINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2016-12-16Labeling · Supplement 20 · standardAP
2016-12-16Labeling · Supplement 21 · standardAP
1999-07-22Manufacturing (CMC) · Supplement 12AP
1995-08-16Manufacturing (CMC) · Supplement 10AP
1995-08-16Manufacturing (CMC) · Supplement 9AP
1992-06-30Labeling · Supplement 7AP
1992-03-06Labeling · Supplement 3AP
1985-08-28Manufacturing (CMC) · Supplement 1AP
1984-08-16OriginalAP
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 →