APPLICATION
ANDA071536
TYPE
ANDA
ORIGINAL APPROVAL
1993-04-28
LATEST ACTION
2012-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2012-05-09Labeling · Supplement 43AP
2011-02-28Labeling · Supplement 42AP
2010-05-24Labeling · Supplement 40AP
2010-05-24Labeling · Supplement 41AP
2006-09-07Labeling · Supplement 34AP
2004-01-02Labeling · Supplement 29AP
2003-06-30Labeling · Supplement 24AP
2002-12-09Labeling · Supplement 20AP
2002-10-07Manufacturing (CMC) · Supplement 15AP
2002-10-07Manufacturing (CMC) · Supplement 13AP
2002-10-07Manufacturing (CMC) · Supplement 14AP
2002-10-07Labeling · Supplement 12AP
2002-06-27Manufacturing (CMC) · Supplement 17AP
2002-04-19Manufacturing (CMC) · Supplement 16AP
2000-05-16Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
2000-04-11Labeling · Supplement 10AP
1997-12-05Manufacturing (CMC) · Supplement 8AP
1997-02-24Manufacturing (CMC) · Supplement 7AP
1997-01-16Labeling · Supplement 5AP
1997-01-16Manufacturing (CMC) · Supplement 6AP
1997-01-16Manufacturing (CMC) · Supplement 4AP
1996-01-16Manufacturing (CMC) · Supplement 3AP
1995-06-22Manufacturing (CMC) · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1993-04-28OriginalAP
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.
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