APPLICATION
ANDA076195
TYPE
ANDA
ORIGINAL APPROVAL
2002-08-30
LATEST ACTION
2023-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
Approval history
2023-10-04Labeling · Supplement 32 · standardAP
2023-10-04Labeling · Supplement 31 · standardAP
2018-01-24Manufacturing (CMC) · Supplement 30 · unknownAP
2016-02-05Manufacturing (CMC) · Supplement 23 · unknownAP
2002-08-30OriginalAP
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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