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FDA ANDA · ANDA065224

CEFTRIAXONE

ceftriaxone sodium

Sponsor: BAXTER HLTHCARE

APPLICATION
ANDA065224
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-23
LATEST ACTION
2024-10-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFTRIAXONE IN PLASTIC CONTAINERPrescription
CEFTRIAXONE SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CEFTRIAXONE IN PLASTIC CONTAINERPrescription
CEFTRIAXONE SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

2024-10-07Labeling · Supplement 15 · standardAP
2024-03-22Labeling · Supplement 14 · standardAP
2022-01-13Labeling · Supplement 13 · standardAP
2013-08-30Labeling · Supplement 8AP
2009-06-18Labeling · Supplement 7AP
2008-03-05Labeling · Supplement 6AP
2007-10-22Labeling · Supplement 3AP
2007-09-12Labeling · Supplement 4AP
2007-04-24Labeling · Supplement 2AP
2005-08-23Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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