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Details for New Drug Application (NDA): 018677

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

The generic ingredient in CESAMET is nabilone. Two suppliers are listed for this compound. Additional details are available on the nabilone profile page.

Summary for NDA: 018677

Tradename:
CESAMET
Applicant:
Meda Pharms
Ingredient:
nabilone
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 018677

Ingredient-typeCannabinoids

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 Meda Pharmaceuticals Inc. 0037-1221 0037-1221-50 1 BOTTLE in 1 CARTON (0037-1221-50) > 50 CAPSULE in 1 BOTTLE
CESAMET
nabilone
CAPSULE;ORAL 018677 NDA Valeant Pharmaceuticals North America 0187-1221 0187-1221-03 50 CAPSULE in 1 BOTTLE (0187-1221-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MG
Approval Date:Dec 26, 1985TE:RLD:Yes

Expired Orange Book Patents for NDA: 018677

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 19853,920,809► subscribe
Meda Pharms
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 19854,087,547► subscribe
Meda Pharms
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 19854,087,545► subscribe
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