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FDA ANDA · ANDA065180

CEFTRIAXONE

Sponsor: APOTEX

APPLICATION
ANDA065180
TYPE
ANDA
ORIGINAL APPROVAL
2006-05-12
LATEST ACTION
2022-01-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFTRIAXONEPrescription
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-01-13Labeling · Supplement 11 · standardAP
2020-09-11Labeling · Supplement 10 · standardAP
2020-09-11Labeling · Supplement 9 · standardAP
2016-03-02Labeling · Supplement 7 · standardAP
2016-03-02Labeling · Supplement 5 · standardAP
2012-08-20Labeling · Supplement 4AP
2006-05-12Original — 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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