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FDA ANDA · ANDA078374

METOCLOPRAMIDE HYDROCHLORIDE

Sponsor: NORTHSTAR HLTHCARE

APPLICATION
ANDA078374
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-30
LATEST ACTION
2015-11-30
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

2015-11-30Labeling · Supplement 8 · standardAP
2013-08-19Labeling · Supplement 6AP
2013-08-19Labeling · Supplement 7 · standardAP
2011-02-28Labeling · Supplement 4 — Review ↗AP
2011-02-28Labeling · Supplement 5 — Review ↗AP
2010-03-30Labeling · Supplement 3 — Review ↗AP
2007-11-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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