APPLICATION
ANDA071291
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-03
LATEST ACTION
2007-11-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2007-11-20Labeling · Supplement 10AP
2001-09-17Manufacturing (CMC) · Supplement 8AP
2000-10-05Labeling · Supplement 7AP
1999-09-13Labeling · Supplement 6AP
1999-06-08Labeling · Supplement 5AP
1998-05-13Labeling · Supplement 4AP
1995-08-07Labeling · Supplement 3AP
1995-01-27Manufacturing (CMC) · Supplement 2AP
1993-06-22Labeling · Supplement 1AP
1989-03-03OriginalAP
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.