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FDA NDA · NDA011556

ANTURANE

Sponsor: NOVARTIS

APPLICATION
NDA011556
TYPE
NDA
ORIGINAL APPROVAL
1959-05-13
LATEST ACTION
2002-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued

Products

ANTURANEDiscontinued
SULFINPYRAZONE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ANTURANE · ReferenceDiscontinued
SULFINPYRAZONE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2002-08-26Labeling · Supplement 53 · standard — Letter ↗AP
1999-04-22Manufacturing (CMC) · Supplement 54 · standardAP
1998-09-12Manufacturing (CMC) · Supplement 52 · standardAP
1993-01-04Manufacturing (CMC) · Supplement 51 · standardAP
1992-10-20Manufacturing (CMC) · Supplement 50 · standardAP
1990-06-13Manufacturing (CMC) · Supplement 49 · standardAP
1987-07-08Manufacturing (CMC) · Supplement 48 · standardAP
1987-03-17Manufacturing (CMC) · Supplement 46 · standardAP
1986-12-08Manufacturing (CMC) · Supplement 44 · standardAP
1986-09-02Manufacturing (CMC) · Supplement 47 · standardAP
1986-04-07Labeling · Supplement 45AP
1985-10-08Manufacturing (CMC) · Supplement 41 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 43 · standardAP
1985-02-27Manufacturing (CMC) · Supplement 42 · standardAP
1984-06-12Labeling · Supplement 38AP
1983-04-09Manufacturing (CMC) · Supplement 40 · standardAP
1980-10-27Manufacturing (CMC) · Supplement 36 · standardAP
1980-02-26Manufacturing (CMC) · Supplement 37 · standardAP
1979-09-07Manufacturing (CMC) · Supplement 35 · standardAP
1979-07-20Manufacturing (CMC) · Supplement 33 · standardAP
1979-07-20Manufacturing (CMC) · Supplement 34 · standardAP
1978-09-26Manufacturing (CMC) · Supplement 31 · standardAP
1978-08-29Manufacturing (CMC) · Supplement 32 · standardAP
1959-05-13Type 1 - New Molecular Entity · 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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