APPLICATION
ANDA074344
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-31
LATEST ACTION
2002-10-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIMETIDINE HYDROCHLORIDEDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/2ML · INJECTABLE · INJECTION
Approval history
2002-10-25Manufacturing (CMC) · Supplement 10AP
2001-03-22Manufacturing (CMC) · Supplement 8AP
2001-03-22Manufacturing (CMC) · Supplement 9AP
2000-01-07Labeling · Supplement 7AP
2000-01-07Manufacturing (CMC) · Supplement 6AP
1996-10-03Manufacturing (CMC) · Supplement 4AP
1996-07-26Labeling · Supplement 5AP
1995-12-22Labeling · Supplement 2AP
1995-01-31OriginalAP
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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