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FDA ANDA · ANDA065342

CEFTRIAXONE

Sponsor: HIKMA FARMACEUTICA

APPLICATION
ANDA065342
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-10
LATEST ACTION
2022-01-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, 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 22 · standardAP
2020-09-11Labeling · Supplement 15 · standardAP
2020-09-11Labeling · Supplement 14 · standardAP
2014-08-29Labeling · Supplement 12 · standardAP
2011-08-04Labeling · Supplement 9AP
2010-07-06Labeling · Supplement 7AP
2009-11-20Labeling · Supplement 4AP
2008-01-10Original — 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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