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FDA ANDA · ANDA204582

BUSPIRONE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA204582
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-18
LATEST ACTION
2019-03-01
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 30MG · TABLET · ORAL
BUSPIRONE HYDROCHLORIDEPrescription
BUSPIRONE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2019-03-01Manufacturing (CMC) · Supplement 2 · unknownAP
2019-03-01Labeling · Supplement 1 · standardAP
2015-09-18UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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