← FDA DRUG APPROVALS

FDA ANDA · ANDA091392

METOCLOPRAMIDE

metoclopramide hydrochloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA091392
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-19
LATEST ACTION
2021-10-27
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION

Approval history

2021-10-27Labeling · Supplement 6 · standardAP
2019-10-30Labeling · Supplement 3 · standardAP
2013-04-19OriginalAP
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 →