RecallHawk

COBENFY (XANOMELINE AND TROSPIUM CHLORIDE)

BRISTOL-MYERS

Summary

FDA approved COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) by BRISTOL-MYERS. NDA (New Drug) approval (Type 1 - New Molecular Entity) on 2024-09-26. CAPSULE, ORAL.

Details

Source

Drug Approval

External ID

NDA216158-1

Action Date

2024-09-26

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

COBENFY (generic: XANOMELINE AND TROSPIUM CHLORIDE), CAPSULE, ORAL. Application: NDA216158

Context & Analysis

BRISTOL-MYERS has 4 FDA actions in our database.

Frequently Asked Questions

How often does BRISTOL-MYERS have FDA actions?

BRISTOL-MYERS has 4 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA216158-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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