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FDA ANDA · ANDA076008

BUSPIRONE HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA076008
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-28
LATEST ACTION
2021-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 10MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEDiscontinued
BUSPIRONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 15MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 5MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2021-02-09Labeling · Supplement 14 · standardAP
2011-10-18Labeling · Supplement 13AP
2011-08-26Labeling · Supplement 9AP
2011-02-01Manufacturing (CMC) · Supplement 8AP
2002-12-23Manufacturing (CMC) · Supplement 4AP
2002-09-06Manufacturing (CMC) · Supplement 3AP
2002-06-28Labeling · Supplement 2AP
2002-05-31Manufacturing (CMC) · Supplement 1AP
2001-06-28OriginalAP
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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