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FDA ANDA · ANDA077426

RANITIDINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA077426
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-19
LATEST ACTION
2007-10-30
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

2007-10-30Labeling · Supplement 1AP
2005-12-19OriginalAP
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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