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FDA ANDA · ANDA062590

KEFUROX IN PLASTIC CONTAINER

Sponsor: LILLY

APPLICATION
ANDA062590
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-10
LATEST ACTION
1993-04-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

KEFUROX IN PLASTIC CONTAINERDiscontinued
CEFUROXIME SODIUM EQ 750MG BASE/VIAL · INJECTABLE · INTRAVENOUS
KEFUROX IN PLASTIC CONTAINERDiscontinued
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

1993-04-14Manufacturing (CMC) · Supplement 9AP
1992-06-12Labeling · Supplement 8AP
1992-06-12Manufacturing (CMC) · Supplement 5AP
1986-10-30Manufacturing (CMC) · Supplement 2AP
1986-09-09Manufacturing (CMC) · Supplement 1AP
1986-01-10OriginalAP
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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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