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FDA ANDA · ANDA075467

BUSPIRONE HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA075467
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-28
LATEST ACTION
2020-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BUSPIRONE HYDROCHLORIDEDiscontinued
BUSPIRONE HYDROCHLORIDE 15MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEDiscontinued
BUSPIRONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEDiscontinued
BUSPIRONE HYDROCHLORIDE 10MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEDiscontinued
BUSPIRONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2020-05-28Labeling · Supplement 21 · standardAP
2012-05-30Labeling · Supplement 17 · standardAP
2008-05-13Labeling · Supplement 15AP
2002-12-23Manufacturing (CMC) · Supplement 9AP
2002-08-23Manufacturing (CMC) · Supplement 7AP
2002-08-23Labeling · Supplement 8AP
2002-07-18Labeling · Supplement 6AP
2002-02-28Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2002-02-28Manufacturing (CMC) · Supplement 3AP
2002-02-28Labeling · Supplement 4 — Letter ↗AP
2002-02-28Labeling · Supplement 2AP
2001-04-23Manufacturing (CMC) · Supplement 1AP
2001-03-28Original — Review ↗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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