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FDA ANDA · ANDA075119

BUSPIRONE HYDROCHLORIDE

Sponsor: EGIS

APPLICATION
ANDA075119
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-14
LATEST ACTION
2003-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2003-01-23Manufacturing (CMC) · Supplement 1AP
2003-01-23Labeling · Supplement 2AP
2002-03-14Original — 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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