← FDA DRUG APPROVALS

FDA NDA · NDA021164

EXXUA

gepirone

Sponsor: FABRE KRAMER

APPLICATION
NDA021164
TYPE
NDA
ORIGINAL APPROVAL
2023-09-22
LATEST ACTION
2025-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

EXXUA · ReferencePrescription
GEPIRONE HYDROCHLORIDE EQ 54.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
EXXUA · ReferencePrescription
GEPIRONE HYDROCHLORIDE EQ 18.2MG BASE · TABLET, EXTENDED RELEASE · ORAL
EXXUA · ReferencePrescription
GEPIRONE HYDROCHLORIDE EQ 72.6MG BASE · TABLET, EXTENDED RELEASE · ORAL
EXXUA · ReferencePrescription
GEPIRONE HYDROCHLORIDE EQ 36.3MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-06-07Labeling · Supplement 1 · standard — Letter ↗AP
2023-09-22Type 1 - New Molecular Entity · Original · standard — 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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