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FDA ANDA · ANDA072744

METOCLOPRAMIDE

metoclopramide hydrochloride

Sponsor: PAI HOLDINGS

APPLICATION
ANDA072744
TYPE
ANDA
ORIGINAL APPROVAL
1991-05-28
LATEST ACTION
2014-01-31
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2014-01-31Labeling · Supplement 16 · standardAP
2014-01-28Labeling · Supplement 14AP
2012-09-10Labeling · Supplement 15 · standardAP
2011-02-28Labeling · Supplement 12AP
2011-02-28Labeling · Supplement 13AP
2009-09-15Labeling · Supplement 11ReviewAP
2009-07-02Labeling · Supplement 10ReviewAP
2002-06-27Labeling · Supplement 6AP
1995-05-12Labeling · Supplement 5AP
1994-05-20Labeling · Supplement 2AP
1993-09-29Labeling · Supplement 1AP
1991-05-28OriginalAP
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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