← FDA DRUG APPROVALS

FDA ANDA · ANDA075742

RANITIDINE HYDROCHLORIDE

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA075742
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-29
LATEST ACTION
2001-04-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2001-04-18Manufacturing (CMC) · Supplement 1AP
2000-11-29Original — 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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