APPLICATION
ANDA070581
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-17
LATEST ACTION
2019-07-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2019-07-30Labeling · Supplement 44 · standardAP
2012-02-21Labeling · Supplement 38AP
2011-02-28Labeling · Supplement 37AP
2010-03-11Labeling · Supplement 35AP
2005-05-05Labeling · Supplement 27AP
2002-05-23Labeling · Supplement 22AP
2002-02-01Labeling · Supplement 20AP
2001-11-02Manufacturing (CMC) · Supplement 21AP
2000-05-26Manufacturing (CMC) · Supplement 19AP
2000-01-27Manufacturing (CMC) · Supplement 17AP
1999-11-24Labeling · Supplement 18AP
1996-01-18Manufacturing (CMC) · Supplement 16AP
1991-07-10Manufacturing (CMC) · Supplement 14AP
1991-03-28Labeling · Supplement 15AP
1988-11-01Labeling · Supplement 12AP
1987-11-23Manufacturing (CMC) · Supplement 10AP
1987-06-23Labeling · Supplement 6AP
1987-06-15Manufacturing (CMC) · Supplement 5AP
1987-06-15Manufacturing (CMC) · Supplement 3AP
1987-06-15Manufacturing (CMC) · Supplement 4AP
1986-11-25Manufacturing (CMC) · Supplement 1AP
1986-11-25Manufacturing (CMC) · Supplement 2AP
1986-09-15Labeling · Supplement 9AP
1985-10-17OriginalAP
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.