← FDA DRUG APPROVALS
FDA ANDA · ANDA074468
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
ANDA074468
TYPE
ANDA
ORIGINAL APPROVAL
1994-12-29
LATEST ACTION
2001-02-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 90MG BASE/100ML · INJECTABLE · INJECTION
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 180MG BASE/100ML · INJECTABLE · INJECTION
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 360MG BASE/100ML · INJECTABLE · INJECTION
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 120MG BASE/100ML · INJECTABLE · INJECTION
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 240MG BASE/100ML · INJECTABLE · INJECTION
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIMETIDINE HYDROCHLORIDE EQ 480MG BASE/100ML · INJECTABLE · INJECTION
Approval history
2001-02-27Manufacturing (CMC) · Supplement 5AP
1996-08-05Labeling · Supplement 4AP
1996-07-22Manufacturing (CMC) · Supplement 2AP
1996-07-03Manufacturing (CMC) · Supplement 1AP
1995-12-22Labeling · Supplement 3AP
1994-12-29OriginalAP
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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