Methylphenidate Extended Release Suspension

Brand(s)
Quillivant
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nextwave Pharmaceuticals, Inc. (2015-11-03)
Oldest Current Product
2012-10-01
License(s)
NDA
RxNORM
EXTENDED RELEASE SUSPENSION\METHYLPHENIDATE
FDAOB
ORAL\FOR SUSPENSION, EXTENDED RELEASE\METHYLPHENIDATE HYDROCHLORIDE
SPL Active
ORAL\POWDER, FOR SUSPENSION\METHYLPHENIDATE HYDROCHLORIDE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\METHYLPHENIDATE

product(s) by strength(s)

24 hr methylphenidate hydrochloride 5 mg/ml extended release suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1244780190QuillivantNDANextwave Pharmaceuticals, Inc.2012-10-01METHYLPHENIDATE HYDROCHLORIDEORALPOWDER, FOR SUSPENSIONNDA202100e0157005-6e3e-4763-b910-9eb0937608c9
2244780205QuillivantNDANextwave Pharmaceuticals, Inc.2013-01-04METHYLPHENIDATE HYDROCHLORIDEORALPOWDER, FOR SUSPENSIONNDA202100e0157005-6e3e-4763-b910-9eb0937608c9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202100QUILLIVANT XRNEXTWAVE PHARMACEUTICALS INC2012-09-27p8465765, TREATMING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUBSTANCE
p8956649, METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER BY ADMINISTERING THE COMPOSITION OF CLAIM 1, SUBSTANCE
p8563033, TREATMING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH METHYLPHENIDATE, SUBSTANCE
p8062667, SUBSTANCE
p8778390, TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR CLAIM 23, SUBSTANCE
p8287903, SUBSTANCE
p9040083, SUBSTANCE
NEW DOSAGE FORM [2015-09-27]NDA202100_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202100_001RXMETHYLPHENIDATE HYDROCHLORIDE (5MG/ML)ORALFOR SUSPENSION, EXTENDED RELEASETrue2012-09-27QUILLIVANT XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8062667 (view patent)2029-03-29NDA202100, NDA022556, NDA207768, NDA208147Chlorpheniramine / Codeine Extended Release Suspension
Amphetamine Extended Release Suspension
carbinoxamine Extended Release Suspension
2p8287903 (view patent)2031-02-15NDA202100
3p8465765 (view patent)2031-02-15NDA202100
4p8563033 (view patent)2031-02-15NDA202100
5p8778390 (view patent)2031-02-15NDA202100
6p8956649 (view patent)2031-02-15NDA202100
7p9040083 (view patent)2031-02-15NDA202100

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e0157005-6e3e-4763-b910-9eb0937608c9 (view SPL)These highlights do not include all the information needed to use QUILLIVANT XR safely and effectively. See full prescribing information for QUILLIVANT XR. QUILLIVANT XR (methylphenidate hydrochloride) for extended-release oral suspension, CIIInitial U.S. Approval: 1955prescriptionHuman PrescriptionNextwave Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE, PACK2015-11-0313244780190, 244780205, 244780200, 244780210

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