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FDA ANDA · ANDA203702

CEFTRIAXONE SODIUM

Sponsor: QILU ANTIBIOTICS

APPLICATION
ANDA203702
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-29
LATEST ACTION
2022-01-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2022-01-13Labeling · Supplement 8 · standardAP
2020-08-07Labeling · Supplement 4 · standardAP
2016-06-29UNKNOWN · OriginalAP
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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