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FDA ANDA · ANDA065263

CEFTRIAXONE

Sponsor: LUPIN

APPLICATION
ANDA065263
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-12
LATEST ACTION
2016-05-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2016-05-27Labeling · Supplement 15 · standardAP
2016-05-27Labeling · Supplement 13 · standardAP
2016-05-27Labeling · Supplement 14 · standardAP
2013-07-02Labeling · Supplement 11 · standardAP
2010-07-06Labeling · Supplement 8AP
2010-02-02Labeling · Supplement 6AP
2008-06-11Labeling · Supplement 3AP
2006-09-12Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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