FDA.reportPublic FDA data

Application 205831

Type
NDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGYesNo
002APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL15MGYesNo
003APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGYesNo
004APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGYesNo
005APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGYesNo
006APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL50MGYesNo
007APTENSIO XRMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-075Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-075Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-076Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-076Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-077Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-077Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-078Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-078Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-079Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-079Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-080Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-080Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-081Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-081Methylphenidate HydrochlorideMethylphenidate HydrochlorideRhodes PharmaceuticalsNDA AUTHORIZED GENERICCurrent
42858-401APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-401APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-401APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-402APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-402APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-402APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-403APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-403APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-403APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-404APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-404APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-404APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-405APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-405APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-405APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-406APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-406APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-406APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-407APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-407APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent
42858-407APTENSIO XR(methylphenidate hydrochloride)Rhodes Pharmaceuticals L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83492SUPPL 2025-09-25
83491SUPPL 2025-09-25
83450SUPPL 2025-09-25
75799SUPPL 2023-10-17
75764SUPPL 2023-10-16
67945SUPPL2021-06-29
67943SUPPL2021-06-29
67937SUPPL2021-06-29
59114SUPPL2019-06-18
59098SUPPL2019-06-17
59097SUPPL2019-06-17
46751SUPPL2017-01-10
46701SUPPL2017-01-06
24506ORIG2015-06-05
23004ORIG2015-06-05
19686ORIG2015-05-12
32739ORIG2015-04-27
63993ORIG1900-01-01
63992ORIG1900-01-01
63227ORIG1900-01-01
51359ORIG1900-01-01
51358ORIG1900-01-01
51357ORIG1900-01-01
51356ORIG1900-01-01