Details for New Drug Application (NDA): 216158
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NDA 216158 describes COBENFY, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from one supplier. Additional details are available on the COBENFY profile page.
The generic ingredient in COBENFY is trospium chloride; xanomeline tartrate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trospium chloride; xanomeline tartrate profile page.
The generic ingredient in COBENFY is trospium chloride; xanomeline tartrate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trospium chloride; xanomeline tartrate profile page.
Summary for 216158
| Tradename: | COBENFY |
| Applicant: | Bristol-myers |
| Ingredient: | trospium chloride; xanomeline tartrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216158
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COBENFY | trospium chloride; xanomeline tartrate | CAPSULE;ORAL | 216158 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0050 | 0003-0050-14 | 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0050-14) |
| COBENFY | trospium chloride; xanomeline tartrate | CAPSULE;ORAL | 216158 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0050 | 0003-0050-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0050-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG;EQ 50MG BASE | ||||
| Approval Date: | Sep 26, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG;EQ 100MG BASE | ||||
| Approval Date: | Sep 26, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG;EQ 125MG BASE | ||||
| Approval Date: | Sep 26, 2024 | TE: | RLD: | Yes | |||||
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