← FDA DRUG APPROVALS

FDA ANDA · ANDA075521

BUSPIRONE HCL

buspirone hydrochloride

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA075521
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-05
LATEST ACTION
2021-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2021-03-03Labeling · Supplement 10 · standardAP
2020-05-28Labeling · Supplement 6 · standardAP
2016-02-29Labeling · Supplement 5 · standardAP
2003-01-03Manufacturing (CMC) · Supplement 1AP
2002-04-05Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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