Details for New Drug Application (NDA): 018677
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The generic ingredient in CESAMET is nabilone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nabilone profile page.
Suppliers and Packaging for NDA: 018677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CESAMET | nabilone | CAPSULE;ORAL | 018677 | NDA | Bausch Health US LLC | 0187-1231 | 0187-1231-50 | 1 BOTTLE in 1 CARTON (0187-1231-50) / 50 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 26, 1985 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 018677
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | CESAMET | nabilone | CAPSULE;ORAL | 018677-001 | Dec 26, 1985 | 4,087,547 | ⤷ Start Trial |
| Bausch | CESAMET | nabilone | CAPSULE;ORAL | 018677-001 | Dec 26, 1985 | 3,920,809 | ⤷ Start Trial |
| Bausch | CESAMET | nabilone | CAPSULE;ORAL | 018677-001 | Dec 26, 1985 | 4,087,545 | ⤷ Start Trial |
| Bausch | CESAMET | nabilone | CAPSULE;ORAL | 018677-001 | Dec 26, 1985 | 3,928,598 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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