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FDA ANDA · ANDA065232

CEFTRIAXONE

Sponsor: HOSPIRA INC

APPLICATION
ANDA065232
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-02
LATEST ACTION
2012-02-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFTRIAXONEDiscontinued
CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2012-02-17Labeling · Supplement 13AP
2010-09-10Labeling · Supplement 12AP
2009-08-27Labeling · Supplement 11AP
2009-08-27Labeling · Supplement 10AP
2008-11-14Labeling · Supplement 9AP
2008-11-14Labeling · Supplement 6AP
2005-08-02OriginalOther Important Information from FDAAP
VIEW ON DRUGS@FDA ↗

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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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