← FDA DRUG APPROVALS

FDA NDA · NDA218808

CRENESSITY

Sponsor: NEUROCRINE

APPLICATION
NDA218808
TYPE
NDA
ORIGINAL APPROVAL
2024-12-13
LATEST ACTION
2024-12-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CRENESSITY · ReferencePrescription
CRINECERFONT 50MG · CAPSULE · ORAL
CRENESSITY · ReferencePrescription
CRINECERFONT 100MG · CAPSULE · ORAL
CRENESSITY · ReferencePrescription
CRINECERFONT 25MG · CAPSULE · ORAL

Approval history

2024-12-13Type 1 - New Molecular Entity · Original · priority — Label ↗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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