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FDA NDA · NDA011323

FUROXONE

Sponsor: SHIRE

APPLICATION
NDA011323
TYPE
NDA
ORIGINAL APPROVAL
1958-01-20
LATEST ACTION
1999-04-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

FUROXONEDiscontinued
FURAZOLIDONE 50MG/15ML · SUSPENSION · ORAL

Approval history

1999-04-15Manufacturing (CMC) · Supplement 19 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 18 · standardAP
1996-04-02Manufacturing (CMC) · Supplement 17 · standardAP
1987-03-03Labeling · Supplement 15 · standardAP
1986-06-20Manufacturing (CMC) · Supplement 12 · standardAP
1986-06-20Manufacturing (CMC) · Supplement 13 · standardAP
1958-01-20Type 4 - New Combination · Original · standardAP
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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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