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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 018677


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NDA 018677 describes CESAMET, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the CESAMET profile page.

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.
Summary for 018677
Tradename:CESAMET
Applicant:Bausch
Ingredient:nabilone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018677
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:RXDosage:CAPSULE;ORALStrength1MG
Approval Date:Dec 26, 1985TE: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 ⤷  Try a Trial ⤷  Try a Trial
Bausch CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bausch CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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