Amphetamine Extended Release Suspension

Brand(s)
Dyanavel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Tris Pharma Inc (2015-10-01)
Oldest Current Product
2015-10-01
License(s)
NDA
RxNORM
EXTENDED RELEASE SUSPENSION\AMPHETAMINE
FDAOB
ORAL\SUSPENSION, EXTENDED RELEASE\AMPHETAMINE
SPL Active
ORAL\SUSPENSION, EXTENDED RELEASE\AMPHETAMINE
SPL Moiety
ORAL\SUSPENSION, EXTENDED RELEASE\AMPHETAMINE

product(s) by strength(s)

24 hr amphetamine 2.5 mg/ml extended release suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1278080102DyanavelNDATris Pharma Inc2015-10-01AMPHETAMINEORALSUSPENSION, EXTENDED RELEASENDA208147a8a7eb93-4192-4826-bbf1-82c06634f553

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA208147DYANAVEL XRTRIS PHARMA INC2015-10-19p8597684, SUBSTANCE
p8883217, SUBSTANCE
p8747902, SUBSTANCE
p8062667, SUBSTANCE
NEW PRODUCT [2018-10-19]NDA208147_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA208147_001RXAMPHETAMINE (EQ 2.5MG BASE/ML)ORALSUSPENSION, EXTENDED RELEASETrue2015-10-19DYANAVEL XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8062667 (view patent)2029-03-29NDA208147, NDA022556, NDA202100, NDA207768Chlorpheniramine / Codeine Extended Release Suspension
Methylphenidate Extended Release Suspension
carbinoxamine Extended Release Suspension
2p8597684 (view patent)2027-03-15NDA208147
3p8747902 (view patent)2027-03-15NDA208147
4p8883217 (view patent)2027-03-15NDA208147

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a8a7eb93-4192-4826-bbf1-82c06634f553 (view SPL)These highlights do not include all the information needed to use DYANAVEL XR safely and effectively. See full prescribing information for DYANAVEL XR . DYANAVEL XR (amphetamine) extended-release oral suspension , CII Initial U.S. Approval: 1 960prescriptionHuman PrescriptionTris Pharma IncMANUFACTURE2015-10-012278080102

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII