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FDA ANDA · ANDA074253

BUSPIRONE HYDROCHLORIDE

Sponsor: IMPAX LABS INC

APPLICATION
ANDA074253
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-28
LATEST ACTION
2020-05-29
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

2020-05-29Labeling · Supplement 8 · standardAP
2012-10-31Labeling · Supplement 5AP
2008-06-03Labeling · Supplement 4AP
2002-03-13Labeling · Supplement 2 — Letter ↗AP
2002-03-13Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2001-03-28Original — 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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