← FDA DRUG APPROVALS

FDA ANDA · ANDA064169

CEFAZOLIN SODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA064169
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-14
LATEST ACTION
2009-05-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2009-05-29Labeling · Supplement 12AP
2005-04-26Labeling · Supplement 7AP
2004-03-08Labeling · Supplement 6AP
2003-08-14Labeling · Supplement 4AP
2002-05-08Manufacturing (CMC) · Supplement 3AP
2001-05-07Manufacturing (CMC) · Supplement 2AP
2001-05-07Manufacturing (CMC) · Supplement 1AP
1998-08-14OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →