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QuintilesIMS
Colorcon
Medtronic
Accenture
Federal Trade Commission
US Department of Justice
Julphar
Farmers Insurance
Covington
Novartis

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018677

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NDA 018677 describes CESAMET, which is a drug marketed by Mylan Speciality Lp 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:1
Applicant:1
Ingredient:1
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

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
Mylan Speciality LpCESAMETnabiloneCAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Speciality LpCESAMETnabiloneCAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Speciality LpCESAMETnabiloneCAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Speciality LpCESAMETnabiloneCAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

UBS
Healthtrust
Julphar
Farmers Insurance
Covington
Daiichi Sankyo
Federal Trade Commission
AstraZeneca
US Army
McKinsey

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