APPLICATION
ANDA074176
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-01
LATEST ACTION
2000-08-09
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CIMETIDINE HYDROCHLORIDEDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML · SOLUTION · ORAL
Approval history
2000-08-09Manufacturing (CMC) · Supplement 7AP
2000-05-26Manufacturing (CMC) · Supplement 6AP
1997-02-10Manufacturing (CMC) · Supplement 4AP
1996-04-24Labeling · Supplement 3AP
1995-02-23Manufacturing (CMC) · Supplement 2AP
1994-11-03Labeling · Supplement 1AP
1994-06-01OriginalAP
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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