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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 four 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-two 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 NDA: 208147

Formulation / Manufacturing:see details

Pharmacology for NDA: 208147

Suppliers and Packaging for NDA: 208147

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION, EXTENDED RELEASE;ORAL 208147 NDA Tris Pharma Inc 27808-102 27808-102-01 464 mL in 1 BOTTLE (27808-102-01)

Summary for product number 001

Approval Date:Oct 19, 2015TE:RLD:Yes
Patent:8,062,667Patent Expiration:Mar 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:8,597,684Patent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,747,902Patent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.