APPLICATION
ANDA074553
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-27
LATEST ACTION
2021-11-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CIMETIDINE HYDROCHLORIDEDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML · SOLUTION · ORAL
Approval history
2021-11-22Manufacturing (CMC) · Supplement 8 · unknownAP
2005-10-07Labeling · Supplement 4AP
1997-01-27OriginalAP
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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