APPLICATION
ANDA071250
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-03
LATEST ACTION
2019-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2019-07-16Labeling · Supplement 37 · standardAP
2012-03-05Labeling · Supplement 34AP
2010-04-29REMS · Supplement 31AP
2002-05-23Labeling · Supplement 15AP
2001-05-29Manufacturing (CMC) · Supplement 14AP
2001-04-18Manufacturing (CMC) · Supplement 13AP
2001-02-05Labeling · Supplement 12AP
2000-09-11Manufacturing (CMC) · Supplement 10AP
2000-07-07Manufacturing (CMC) · Supplement 11AP
2000-06-27Manufacturing (CMC) · Supplement 8AP
1999-11-24Labeling · Supplement 9AP
1995-12-21Manufacturing (CMC) · Supplement 7AP
1995-09-19Labeling · Supplement 6AP
1994-11-03Labeling · Supplement 5AP
1994-05-11Manufacturing (CMC) · Supplement 4AP
1992-04-30Labeling · Supplement 3AP
1991-07-02Labeling · Supplement 2AP
1988-02-03OriginalAP
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.
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