APPLICATION
ANDA073135
TYPE
ANDA
ORIGINAL APPROVAL
1991-11-27
LATEST ACTION
2024-03-06
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-03-06Labeling · Supplement 28 · standardAP
2024-03-06Labeling · Supplement 25 · standardAP
2013-09-19Labeling · Supplement 19 · standardAP
2010-06-03Labeling · Supplement 9AP
2004-05-19Labeling · Supplement 7AP
2002-08-22Labeling · Supplement 5AP
1999-11-24Labeling · Supplement 4AP
1996-03-06Labeling · Supplement 3AP
1995-06-02Manufacturing (CMC) · Supplement 2AP
1993-12-10Manufacturing (CMC) · Supplement 1AP
1991-11-27OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.