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FDA ANDA · ANDA074269
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA074269
TYPE
ANDA
ORIGINAL APPROVAL
1994-12-27
LATEST ACTION
1998-12-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 6MG BASE/ML · INJECTABLE · INJECTION
Approval history
1998-12-01Manufacturing (CMC) · Supplement 7AP
1997-06-02Manufacturing (CMC) · Supplement 6AP
1996-07-03Manufacturing (CMC) · Supplement 2AP
1996-04-17Labeling · Supplement 5AP
1996-03-12Manufacturing (CMC) · Supplement 4AP
1995-08-24Labeling · Supplement 3AP
1995-03-16Labeling · Supplement 1AP
1994-12-27OriginalAP
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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