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FDA NDA · NDA050796

CEFTRIAXONE AND DEXTROSE

ceftriaxone

Sponsor: B BRAUN

APPLICATION
NDA050796
TYPE
NDA
ORIGINAL APPROVAL
2005-04-20
LATEST ACTION
2022-01-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER · ReferencePrescription
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER · ReferencePrescription
CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-01-13Labeling · Supplement 30 · standard — Label ↗AP
2021-03-09Labeling · Supplement 25 · standard — Letter ↗AP
2020-09-09Labeling · Supplement 23 · standard — Letter ↗AP
2015-07-09Labeling · Supplement 19 · standard — Letter ↗AP
2014-02-07Manufacturing (CMC) · Supplement 18 · standardAP
2013-04-10Labeling · Supplement 17 · standard — Letter ↗AP
2013-03-11Labeling · Supplement 14 · unknown — Label ↗AP
2012-01-13Labeling · Supplement 11 · standard — Letter ↗AP
2010-06-25Labeling · Supplement 12 · unknown — Label ↗AP
2008-05-08Labeling · Supplement 7 · standard — Letter ↗AP
2008-05-08Labeling · Supplement 8 · standard — Letter ↗AP
2007-09-10Labeling · Supplement 4 · standard — Label ↗AP
2005-04-20Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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