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FDA ANDA · ANDA077878

METOCLOPRAMIDE HYDROCHLORIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA077878
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-28
LATEST ACTION
2019-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2019-07-16Labeling · Supplement 12 · standardAP
2012-08-13Labeling · Supplement 5AP
2011-02-28Labeling · Supplement 4AP
2010-04-30Labeling · Supplement 3AP
2010-04-30Labeling · Supplement 2AP
2006-08-28OriginalAP
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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