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FDA ANDA · ANDA065168

CEFTRIAXONE SODIUM

Sponsor: SANDOZ

APPLICATION
ANDA065168
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-17
LATEST ACTION
2022-01-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2022-01-13Labeling · Supplement 32 · standardAP
2016-03-05Labeling · Supplement 23 · standardAP
2016-03-05Labeling · Supplement 22 · standardAP
2014-01-31Labeling · Supplement 19 · standard — Label ↗AP
2012-02-17Labeling · Supplement 15AP
2010-09-23Labeling · Supplement 9AP
2009-01-14Labeling · Supplement 5AP
2005-05-17Original — 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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