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FDA ANDA · ANDA064170

CEFAZOLIN SODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA064170
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-18
LATEST ACTION
2009-05-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CEFAZOLIN SODIUMDiscontinued
CEFAZOLIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION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 13AP
2006-01-27Labeling · Supplement 11AP
2005-04-20Labeling · Supplement 7AP
2004-03-08Labeling · Supplement 6AP
2003-08-15Labeling · Supplement 4AP
2002-05-08Manufacturing (CMC) · Supplement 3AP
2001-05-07Manufacturing (CMC) · Supplement 2AP
2001-05-07Manufacturing (CMC) · Supplement 1AP
1998-03-18OriginalReviewAP
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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