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FDA ANDA · ANDA075560

CIMETIDINE HYDROCHLORIDE

Sponsor: PHARM ASSOC

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
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