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FDA ANDA · ANDA074655

RANITIDINE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA074655
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-22
LATEST ACTION
2013-02-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RANITIDINE HYDROCHLORIDEPrescription
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
RANITIDINE HYDROCHLORIDEPrescription
RANITIDINE HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL

Approval history

2013-02-07Labeling · Supplement 35AP
2009-05-27Labeling · Supplement 34AP
2007-12-26Labeling · Supplement 28AP
2005-04-28Labeling · Supplement 23AP
2004-03-12Labeling · Supplement 17AP
2002-04-19Manufacturing (CMC) · Supplement 11AP
2001-11-06Manufacturing (CMC) · Supplement 10AP
2001-03-19Manufacturing (CMC) · Supplement 9AP
2001-01-26Manufacturing (CMC) · Supplement 8AP
2000-11-30Manufacturing (CMC) · Supplement 7AP
2000-05-25Labeling · Supplement 6AP
2000-03-03Labeling · Supplement 5AP
2000-02-02Manufacturing (CMC) · Supplement 4AP
1999-08-09Manufacturing (CMC) · Supplement 3AP
1998-05-20Manufacturing (CMC) · Supplement 1AP
1998-05-20Manufacturing (CMC) · Supplement 2AP
1997-10-22Original — Review ↗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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