FDA.reportPublic FDA data

Application 214324

Type
NDA
Sponsor
UNITED THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYVASO DPITREPROSTINILPOWDER;INHALATION16MCGYesNo
002TYVASO DPITREPROSTINILPOWDER;INHALATION0.032MG/INHYesYes
003TYVASO DPITREPROSTINILPOWDER;INHALATION0.048MG/INHYesYes
004TYVASO DPITREPROSTINILPOWDER;INHALATION0.064MG/INHYesYes
005TYVASO DPITREPROSTINILPOWDER;INHALATION0.08MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66302-600Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-610Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-616Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-620Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-632Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-648Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-664Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-716Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-720Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-732Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-748Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent
66302-764Tyvaso DPItreprostinilUnited Therapeutics CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71519ORIG2022-07-06
71138ORIG2022-05-24
71137ORIG2022-05-24