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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Moodys
Covington
QuintilesIMS
Johnson and Johnson
Harvard Business School
US Department of Justice
Queensland Health

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208147

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NDA 208147 describes DYANAVEL XR, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DYANAVEL XR profile page.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Summary for 208147
Tradename:DYANAVEL XR
Applicant:Tris Pharma Inc
Ingredient:amphetamine
Patents:5
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208147
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYANAVEL XR amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147 NDA Tris Pharma Inc 27808-102 N 27808-102-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 2.5MG BASE/ML
Approval Date:Oct 19, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 19, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Fish and Richardson
Johnson and Johnson
Daiichi Sankyo
Cantor Fitzgerald
US Department of Justice
Mallinckrodt
Farmers Insurance

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