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FDA NDA · NDA018731

BUSPAR

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA018731
TYPE
NDA
ORIGINAL APPROVAL
1986-09-29
LATEST ACTION
2010-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BUSPAR · ReferenceDiscontinued
BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BUSPAR · ReferenceDiscontinued
BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BUSPAR · ReferenceDiscontinued
BUSPIRONE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
BUSPAR · ReferenceDiscontinued
BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2010-11-22Labeling · Supplement 51 · priority — Label ↗AP
2007-09-21Labeling · Supplement 48 · priority — Letter ↗AP
2002-02-07Labeling · Supplement 46 · priority — Letter ↗AP
2001-07-19Efficacy · Supplement 43 · priority — Label ↗AP
2001-05-03Labeling · Supplement 39 · priority — Label ↗AP
2001-05-03Labeling · Supplement 45 · priority — Label ↗AP
2000-04-25Manufacturing (CMC) · Supplement 42 · priorityAP
1999-11-01Manufacturing (CMC) · Supplement 41 · priorityAP
1999-07-27Manufacturing (CMC) · Supplement 40 · priorityAP
1999-01-27Manufacturing (CMC) · Supplement 38 · priorityAP
1998-06-19Manufacturing (CMC) · Supplement 36 · priorityAP
1998-05-20Labeling · Supplement 33 · priorityAP
1998-05-20Labeling · Supplement 34 · priorityAP
1998-04-03Manufacturing (CMC) · Supplement 35 · priorityAP
1998-03-02Labeling · Supplement 20 · priorityAP
1996-12-30Manufacturing (CMC) · Supplement 32 · priorityAP
1996-06-19Manufacturing (CMC) · Supplement 30 · priorityAP
1996-04-22Labeling · Supplement 27 · priorityAP
1996-04-22Manufacturing (CMC) · Supplement 25 · priorityAP
1996-04-22Efficacy · Supplement 31 · priorityAP
1996-03-20Manufacturing (CMC) · Supplement 29 · priorityAP
1993-09-23Labeling · Supplement 26 · priorityAP
1991-07-31Labeling · Supplement 18 · priorityAP
1990-10-05Manufacturing (CMC) · Supplement 23 · priorityAP
1990-01-26Manufacturing (CMC) · Supplement 19 · priorityAP
1990-01-26Manufacturing (CMC) · Supplement 21 · priorityAP
1989-07-25Labeling · Supplement 8 · priorityAP
1989-07-25Manufacturing (CMC) · Supplement 6 · priorityAP
1989-04-28Manufacturing (CMC) · Supplement 17 · priorityAP
1989-03-02Manufacturing (CMC) · Supplement 14 · priorityAP
1989-03-02Manufacturing (CMC) · Supplement 15 · priorityAP
1988-11-02Labeling · Supplement 11 · priorityAP
1988-10-13Manufacturing (CMC) · Supplement 16 · priorityAP
1988-06-23Manufacturing (CMC) · Supplement 10 · priorityAP
1987-08-10Labeling · Supplement 9 · priorityAP
1987-04-23Manufacturing (CMC) · Supplement 5 · priorityAP
1986-12-16Manufacturing (CMC) · Supplement 4 · priorityAP
1986-12-16Manufacturing (CMC) · Supplement 3 · priorityAP
1986-09-29Type 1 - New Molecular Entity · Original · priority — Review ↗AP
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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