← FDA DRUG APPROVALS

FDA ANDA · ANDA065305

CEFTRIAXONE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA065305
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-11
LATEST ACTION
2022-01-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2022-01-13Labeling · Supplement 6 · standardAP
2009-09-28Labeling · Supplement 2AP
2009-09-28Labeling · Supplement 3AP
2009-01-15Labeling · Supplement 1AP
2008-01-11Original — 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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