APPLICATION
ANDA078807
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-12
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2025-08-01Labeling · Supplement 14 · standardAP
2025-08-01Labeling · Supplement 13 · standardAP
2019-04-05Labeling · Supplement 10 · standardAP
2012-03-08Labeling · Supplement 8AP
2012-02-21Labeling · Supplement 6AP
2010-03-31Labeling · Supplement 3AP
2009-12-01Labeling · Supplement 2AP
2008-06-12OriginalAP
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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