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FDA ANDA · ANDA072038

METOCLOPRAMIDE HYDROCHLORIDE

Sponsor: ROXANE

APPLICATION
ANDA072038
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-05
LATEST ACTION
1999-08-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

METOCLOPRAMIDE HYDROCHLORIDEDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML · SOLUTION · ORAL

Approval history

1999-08-12Manufacturing (CMC) · Supplement 14AP
1998-08-14Manufacturing (CMC) · Supplement 3AP
1998-08-14Labeling · Supplement 4AP
1998-07-21Manufacturing (CMC) · Supplement 15AP
1997-10-20Manufacturing (CMC) · Supplement 11AP
1997-10-20Manufacturing (CMC) · Supplement 12AP
1996-08-28Manufacturing (CMC) · Supplement 10AP
1996-02-14Labeling · Supplement 9AP
1996-02-14Manufacturing (CMC) · Supplement 8AP
1993-04-01Labeling · Supplement 7AP
1991-05-06Labeling · Supplement 6AP
1991-02-13Labeling · Supplement 5AP
1989-03-08Manufacturing (CMC) · Supplement 1AP
1988-12-05OriginalAP
VIEW ON DRUGS@FDA ↗

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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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