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FDA ANDA · ANDA075385

BUSPIRONE HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075385
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-01
LATEST ACTION
2015-11-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL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BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL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BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-11-03Labeling · Supplement 10AP
2008-02-06Labeling · Supplement 5AP
2005-04-27Labeling · Supplement 3AP
2002-03-01Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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