APPLICATION
ANDA065306
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-22
LATEST ACTION
2014-12-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 20GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2014-12-02Labeling · Supplement 6 · standardAP
2014-08-18Manufacturing (CMC) · Supplement 3AP
2013-02-13Labeling · Supplement 4AP
2011-05-26Labeling · Supplement 2AP
2010-07-20Labeling · Supplement 1AP
2008-10-22OriginalAP
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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