FDA.reportPublic FDA data

Application 212038

Type
NDA
Sponsor
PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADHANSIA XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL25MGYesNo
002ADHANSIA XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL35MGYesNo
003ADHANSIA XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL45MGYesNo
004ADHANSIA XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL55MGYesNo
005ADHANSIA XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL70MGYesNo
006ADHANSIA XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL85MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochloride Extented Release CapsulesAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-525ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochloride Extented Release CapsulesAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-535ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochloride Extented Release CapsulesAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-545ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochloride Extented Release CapsulesAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-555ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochloride Extented Release CapsulesAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-570ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochloride Extented Release CapsulesAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent
72912-585ADHANSIA XRmethylphenidate hydrochlorideAdlon Therapeutics L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67992SUPPL2021-06-30
67991SUPPL2021-06-30
69277SUPPL2021-06-29
67960SUPPL2021-06-29
67927SUPPL2021-06-28
67926SUPPL2021-06-28
59295SUPPL2019-07-10
59294SUPPL2019-07-10
59248SUPPL2019-07-05
59229ORIG2019-07-03
57828ORIG2019-02-28
57827ORIG2019-02-27
64328ORIG1900-01-01
64327ORIG1900-01-01
63147ORIG1900-01-01
63146ORIG1900-01-01
63145ORIG1900-01-01