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FDA ANDA · ANDA075296

RANITIDINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA075296
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-14
LATEST ACTION
2002-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL

Approval history

2002-08-20Labeling · Supplement 7AP
2001-10-18Manufacturing (CMC) · Supplement 6AP
2000-09-07Manufacturing (CMC) · Supplement 4AP
2000-09-07Manufacturing (CMC) · Supplement 5AP
2000-07-26Manufacturing (CMC) · Supplement 1AP
2000-07-26Manufacturing (CMC) · Supplement 2AP
2000-07-26Labeling · Supplement 3AP
2000-01-14Original — 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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