FDA.reportPublic FDA data

Application 209311

Type
NDA
Sponsor
IRONSHORE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JORNAY PMMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGYesNo
002JORNAY PMMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGYesNo
003JORNAY PMMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGYesNo
004JORNAY PMMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL80MGYesNo
005JORNAY PMMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals Inc.NDACurrent
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-201JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-202JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-203JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals Inc.NDACurrent
71376-204JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent
71376-205JORNAY PMMethylphenidate HydrochlorideIronshore Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83517SUPPL 2025-09-25
83516SUPPL 2025-09-25
83454SUPPL 2025-09-25
75797SUPPL 2023-10-17
75765SUPPL 2023-10-16
67962SUPPL2021-06-29
67957SUPPL2021-06-29
67956SUPPL2021-06-29
58796SUPPL2019-05-20
58795SUPPL2019-05-20
58773SUPPL2019-05-17
57351ORIG2019-01-28
55164ORIG2018-08-10
55152ORIG2018-08-10
55151ORIG2018-08-10