APPLICATION
ANDA072801
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-15
LATEST ACTION
2019-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2019-07-16Labeling · Supplement 44 · standardAP
2014-12-10Labeling · Supplement 41AP
2014-09-22Manufacturing (CMC) · Supplement 36AP
2011-02-28Labeling · Supplement 38AP
2010-03-31REMS · Supplement 37AP
2009-11-06Labeling · Supplement 35AP
2007-01-24Labeling · Supplement 28AP
2002-08-12Labeling · Supplement 19AP
2001-11-13Manufacturing (CMC) · Supplement 18AP
2001-10-24Manufacturing (CMC) · Supplement 17AP
2001-01-29Labeling · Supplement 16AP
2000-07-07Manufacturing (CMC) · Supplement 15AP
2000-01-27Manufacturing (CMC) · Supplement 12AP
1999-12-22Labeling · Supplement 14AP
1999-10-27Labeling · Supplement 13AP
1999-03-26Manufacturing (CMC) · Supplement 11AP
1998-07-01Manufacturing (CMC) · Supplement 10AP
1997-06-18Manufacturing (CMC) · Supplement 9AP
1996-03-11Labeling · Supplement 8AP
1995-10-25Manufacturing (CMC) · Supplement 7AP
1995-02-16Manufacturing (CMC) · Supplement 6AP
1994-12-28Manufacturing (CMC) · Supplement 5AP
1994-09-06Manufacturing (CMC) · Supplement 4AP
1994-06-17Manufacturing (CMC) · Supplement 3AP
1994-03-10Labeling · Supplement 2AP
1993-10-18Manufacturing (CMC) · Supplement 1AP
1993-06-15OriginalAP
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.