APPLICATION
ANDA065328
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-24
LATEST ACTION
2022-01-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2022-01-13Labeling · Supplement 16 · standardAP
2016-03-02Labeling · Supplement 12 · standardAP
2014-11-26Labeling · Supplement 10 · standardAP
2013-03-22Labeling · Supplement 9 · standardAP
2012-08-24Labeling · Supplement 7AP
2011-09-30Labeling · Supplement 5AP
2011-08-04Labeling · Supplement 8AP
2010-01-04Labeling · Supplement 4AP
2010-01-04Labeling · Supplement 3AP
2009-12-29Labeling · Supplement 2AP
2009-10-26Labeling · Supplement 1AP
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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