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FDA ANDA · ANDA065169

CEFTRIAXONE SODIUM

Sponsor: SANDOZ

APPLICATION
ANDA065169
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-09
LATEST ACTION
2022-01-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS

Approval history

2022-01-13Labeling · Supplement 35 · standardAP
2016-03-05Labeling · Supplement 26 · standardAP
2016-03-05Labeling · Supplement 25 · standardAP
2014-02-05Labeling · Supplement 22 · standardLabelAP
2011-07-13Labeling · Supplement 18AP
2010-11-24Labeling · Supplement 14AP
2009-06-05Labeling · Supplement 8AP
2009-01-14Labeling · Supplement 6AP
2005-05-09OriginalOther Important Information from FDAAP
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