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FDA ANDA · ANDA077824

RANITIDINE

Sponsor: AMNEAL PHARMS NY

APPLICATION
ANDA077824
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-13
LATEST ACTION
2017-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 300MG BASE · TABLET · ORAL
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL

Approval history

2017-02-07Manufacturing (CMC) · Supplement 16 · unknownAP
2010-04-30Labeling · Supplement 5AP
2008-03-20Manufacturing (CMC) · Supplement 1AP
2006-10-13OriginalAP
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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