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FDA ANDA · ANDA075180

RANITIDINE HYDROCHLORIDE

Sponsor: PH HEALTH

APPLICATION
ANDA075180
TYPE
ANDA
ORIGINAL APPROVAL
1999-01-28
LATEST ACTION
2007-09-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2007-09-06Labeling · Supplement 14AP
2006-10-31Labeling · Supplement 11AP
2003-04-04Labeling · Supplement 5AP
2002-07-15Manufacturing (CMC) · Supplement 6AP
2001-01-18Labeling · Supplement 1AP
1999-01-28Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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