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FDA NDA · NDA065214

CEFOXITIN AND DEXTROSE

cefoxitin sodium

Sponsor: B BRAUN

APPLICATION
NDA065214
TYPE
NDA
ORIGINAL APPROVAL
2006-03-10
LATEST ACTION
2019-07-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2019-07-29Labeling · Supplement 16 · standard — Letter ↗AP
2013-06-05Labeling · Supplement 13 · standard — Label ↗AP
2012-12-12Manufacturing (CMC) · Supplement 12AP
2010-02-22Labeling · Supplement 8 · standard — Label ↗AP
2010-02-04Labeling · Supplement 2 — Label ↗AP
2008-01-07Labeling · Supplement 5 · standardAP
2006-03-10UNKNOWN · Original · unknownAP
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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