APPLICATION
ANDA062831
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-09
LATEST ACTION
2016-06-24
ROUTE
INTRAVENOUS, PARENTERAL, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2016-06-24Labeling · Supplement 33 · standardAP
2016-06-24Labeling · Supplement 38 · standardAP
2013-01-15Labeling · Supplement 29AP
2008-02-12Labeling · Supplement 18AP
2006-06-01Labeling · Supplement 15AP
1999-03-05Manufacturing (CMC) · Supplement 9AP
1998-11-25Manufacturing (CMC) · Supplement 7AP
1998-11-25Labeling · Supplement 8AP
1995-05-16Labeling · Supplement 6AP
1992-12-15Manufacturing (CMC) · Supplement 2AP
1992-12-15Labeling · Supplement 1AP
1992-09-25Labeling · Supplement 5AP
1991-11-18Labeling · Supplement 3AP
1990-07-17Manufacturing (CMC) · Supplement 4AP
1988-12-09OriginalAP
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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