APPLICATION
ANDA075388
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-09
LATEST ACTION
2026-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 15MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 5MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-04-15Manufacturing (CMC) · Supplement 12 · unknownAP
2020-05-28Labeling · Supplement 6 · standardAP
2008-03-16Labeling · Supplement 4AP
2002-05-09OriginalAP
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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