← FDA DRUG APPROVALS

FDA NDA · NDA050779

CEFAZOLIN SODIUM

Sponsor: B BRAUN

APPLICATION
NDA050779
TYPE
NDA
ORIGINAL APPROVAL
2000-07-27
LATEST ACTION
2025-01-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

CEFAZOLIN AND DEXTROSE · ReferencePrescription
CEFAZOLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN AND DEXTROSEDiscontinued
CEFAZOLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN AND DEXTROSE · ReferencePrescription
CEFAZOLIN SODIUM EQ 3GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN AND DEXTROSE · ReferencePrescription
CEFAZOLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-01-17Labeling · Supplement 35 · standard — Letter ↗AP
2024-08-26Efficacy · Supplement 34 · standard — Letter ↗AP
2021-10-08Labeling · Supplement 31 · standard — Letter ↗AP
2020-11-23Efficacy · Supplement 27 · standard — Label ↗AP
2015-10-08Labeling · Supplement 25 · standard — Label ↗AP
2014-09-18Efficacy · Supplement 23 · priority — Letter ↗AP
2014-03-11Manufacturing (CMC) · Supplement 21 · standardAP
2013-08-21Manufacturing (CMC) · Supplement 22 · standardAP
2012-12-10Manufacturing (CMC) · Supplement 20 · standardAP
2012-04-23Labeling · Supplement 19 · unknown — Label ↗AP
2012-01-13Efficacy · Supplement 18 · standard — Label ↗AP
2008-10-31Labeling · Supplement 11 · standard — Label ↗AP
2007-09-10Labeling · Supplement 13 · standard — Label ↗AP
2005-05-06Labeling · Supplement 6 · standard — Letter ↗AP
2004-06-29Labeling · Supplement 5 · standard — Label ↗AP
2001-06-01Labeling · Supplement 1 · standardAP
2000-07-27Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
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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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