APPLICATION
ANDA063016
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-14
LATEST ACTION
1994-10-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
1994-10-21Labeling · Supplement 3AP
1993-03-10Labeling · Supplement 2AP
1990-02-22Manufacturing (CMC) · Supplement 1AP
1989-03-14OriginalAP
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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