FDA.reportPublic FDA data

Application 203496

Type
NDA
Sponsor
UNITED THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 0.125MG BASEYesNo
002ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 0.25MG BASEYesNo
003ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 1MG BASEYesYes
004ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 2.5MG BASEYesNo
005ORENITRAMTREPROSTINIL DIOLAMINETABLET, EXTENDED RELEASE;ORALEQ 5MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66302-300OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-300OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-302OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-310OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-325OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics CorporationNDACurrent
66302-350OrenitramtreprostinilUnited Therapeutics Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84389SUPPL 2025-12-12
67028SUPPL2021-04-12
60618SUPPL2019-10-22
60597SUPPL2019-10-21
48753SUPPL2017-06-16
48715SUPPL2017-06-14
47005SUPPL2017-01-27
46981SUPPL2017-01-24
40306SUPPL2016-02-11
10227SUPPL2016-01-28
24436ORIG2014-12-09
22924ORIG2014-12-09
40305SUPPL2014-10-09
10226SUPPL2014-10-08
32433ORIG2013-12-24
19478ORIG2013-12-23