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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Mallinckrodt
Colorcon
Deloitte
Dow
Accenture
Fuji
McKinsey
Farmers Insurance

Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021777

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NDA 021777 describes AMRIX, which is a drug marketed by Teva Pharms Intl and is included in one NDA. It is available from six suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AMRIX profile page.

The generic ingredient in AMRIX is cyclobenzaprine hydrochloride. There are fifteen drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 021777
Tradename:AMRIX
Applicant:Teva Pharms Intl
Ingredient:cyclobenzaprine hydrochloride
Patents:7
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021777
Suppliers and Packaging for NDA: 021777
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777 NDA Rebel Distributors Corp. 21695-723 E 21695-723-14
AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777 NDA Rebel Distributors Corp. 21695-723 E 21695-723-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Feb 1, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 26, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 14, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:RELIEF OF MUSCLE SPASM
Patent:➤ Sign UpPatent Expiration:Nov 14, 2023Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Teva
Chinese Patent Office
Covington
US Department of Justice
Chubb
Boehringer Ingelheim
Fish and Richardson

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