APPLICATION
ANDA078246
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-27
LATEST ACTION
2020-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 30MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 10MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 15MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2020-02-21Manufacturing (CMC) · Supplement 2 · standardAP
2010-12-21Labeling · Supplement 1AP
2009-02-27OriginalAP
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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