← FDA DRUG APPROVALS

FDA NDA · NDA216158

COBENFY

xanomeline and trospium chloride

Sponsor: BRISTOL-MYERS

APPLICATION
NDA216158
TYPE
NDA
ORIGINAL APPROVAL
2024-09-26
LATEST ACTION
2024-09-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

COBENFY · ReferencePrescription
TROSPIUM CHLORIDE 30MG, XANOMELINE TARTRATE EQ 125MG BASE · CAPSULE · ORAL
COBENFY · ReferencePrescription
TROSPIUM CHLORIDE 20MG, XANOMELINE TARTRATE EQ 50MG BASE · CAPSULE · ORAL
COBENFY · ReferencePrescription
TROSPIUM CHLORIDE 20MG, XANOMELINE TARTRATE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2024-09-26Type 1 - New Molecular Entity · Original · standard — Label ↗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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