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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

Tradename:
DYANAVEL XR
Applicant:
Tris Pharma Inc
Ingredient:
amphetamine
Patents:4
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
DYANAVEL XR
amphetamine
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

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 2.5MG BASE/ML
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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