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FDA ANDA · ANDA065329

CEFTRIAXONE

Sponsor: ACS DOBFAR

APPLICATION
ANDA065329
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-24
LATEST ACTION
2022-01-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-01-13Labeling · Supplement 19 · standardAP
2016-03-02Labeling · Supplement 10 · standardAP
2014-11-07Labeling · Supplement 7 · standardAP
2012-05-02Labeling · Supplement 6AP
2010-11-29Labeling · Supplement 4AP
2010-01-24Labeling · Supplement 2AP
2009-10-15Labeling · Supplement 1AP
2008-07-24Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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