APPLICATION
NDA050637
TYPE
NDA
ORIGINAL APPROVAL
1989-12-11
LATEST ACTION
2001-09-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ZEFAZONE · ReferenceDiscontinued
CEFMETAZOLE SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZEFAZONE · ReferenceDiscontinued
CEFMETAZOLE SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-09-17Labeling · Supplement 7 · standardAP
2001-09-17Efficacy · Supplement 3AP
2001-09-17Efficacy · Supplement 6AP
1993-12-08Manufacturing (CMC) · Supplement 5 · standardAP
1993-07-30Labeling · Supplement 8 · standardAP
1993-07-30Labeling · Supplement 4AP
1992-09-29Efficacy · Supplement 1AP
1989-12-11Type 1 - New Molecular Entity · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.