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FDA ANDA · ANDA065465

CEFTRIAXONE

Sponsor: BEDFORD

APPLICATION
ANDA065465
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-18
LATEST ACTION
2014-12-02
ROUTE
INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2014-12-02Labeling · Supplement 5 · standardAP
2011-07-05Labeling · Supplement 4AP
2010-04-22Labeling · Supplement 3AP
2009-11-20Labeling · Supplement 2AP
2009-06-06Labeling · Supplement 1AP
2008-08-18OriginalOther 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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