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FDA ANDA · ANDA065141

CEFAZOLIN

cefazolin sodium

Sponsor: SAMSON MEDCL

APPLICATION
ANDA065141
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-29
LATEST ACTION
2018-09-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 100GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 300GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2018-09-28Labeling · Supplement 4 · standardAP
2018-09-28Labeling · Supplement 5 · standardAP
2013-07-30Labeling · Supplement 3LabelAP
2006-11-29OriginalAP
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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