APPLICATION
ANDA075560
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-15
LATEST ACTION
2001-01-26
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CIMETIDINE HYDROCHLORIDEDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML · SOLUTION · ORAL
Approval history
2001-01-26Manufacturing (CMC) · Supplement 3AP
2000-10-26Manufacturing (CMC) · Supplement 2AP
2000-03-15OriginalAP
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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