APPLICATION
ANDA071340
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-18
LATEST ACTION
2003-04-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML · SOLUTION · ORAL
Approval history
2003-04-11Labeling · Supplement 23AP
2002-10-30Manufacturing (CMC) · Supplement 21AP
2002-10-30Manufacturing (CMC) · Supplement 22AP
2001-07-10Labeling · Supplement 20AP
2000-07-31Manufacturing (CMC) · Supplement 19AP
2000-05-24Labeling · Supplement 18AP
1998-10-21Manufacturing (CMC) · Supplement 17AP
1998-10-21Manufacturing (CMC) · Supplement 16AP
1998-05-20Manufacturing (CMC) · Supplement 15AP
1996-04-12Labeling · Supplement 13AP
1994-09-15Manufacturing (CMC) · Supplement 12AP
1993-08-25Labeling · Supplement 10AP
1993-03-29Labeling · Supplement 9AP
1991-09-27Manufacturing (CMC) · Supplement 4AP
1991-09-27Manufacturing (CMC) · Supplement 7AP
1991-09-27Manufacturing (CMC) · Supplement 3AP
1991-04-02Manufacturing (CMC) · Supplement 6AP
1990-09-28Manufacturing (CMC) · Supplement 11AP
1990-06-05Labeling · Supplement 5AP
1988-08-18OriginalAP
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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