APPLICATION
ANDA062989
TYPE
ANDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2000-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 20GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2000-12-08Manufacturing (CMC) · Supplement 21AP
2000-01-05Manufacturing (CMC) · Supplement 20AP
1999-02-19Manufacturing (CMC) · Supplement 19AP
1998-09-29Manufacturing (CMC) · Supplement 18AP
1998-09-18Manufacturing (CMC) · Supplement 17AP
1998-02-12Manufacturing (CMC) · Supplement 16AP
1997-07-15Labeling · Supplement 14AP
1995-06-22Manufacturing (CMC) · Supplement 13AP
1995-01-27Manufacturing (CMC) · Supplement 10AP
1995-01-27Manufacturing (CMC) · Supplement 9AP
1994-12-22Labeling · Supplement 11AP
1994-03-10Labeling · Supplement 7AP
1994-01-13Manufacturing (CMC) · Supplement 8AP
1993-11-19Manufacturing (CMC) · Supplement 6AP
1993-02-08Manufacturing (CMC) · Supplement 5AP
1992-11-20Manufacturing (CMC) · Supplement 1AP
1989-12-29OriginalAP
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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