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FDA ANDA · ANDA076705

RANITIDINE HYDROCHLORIDE

Sponsor: DR REDDYS LABS INC

APPLICATION
ANDA076705
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-27
LATEST ACTION
2009-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2009-12-28Labeling · Supplement 3AP
2009-05-28Labeling · Supplement 2AP
2007-10-30Labeling · Supplement 1AP
2005-07-27OriginalAP
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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