FDA.reportPublic FDA data

Application 021272

Type
NDA
Sponsor
UNITED THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMODULINTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS1MG/MLYesYes
002REMODULINTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS2.5MG/MLYesYes
003REMODULINTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS5MG/MLYesYes
004REMODULINTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS10MG/MLYesYes
005REMODULINTREPROSTINILINJECTABLE;IV (INFUSION), SUBCUTANEOUS20MG/MLYesNo
006REMODULINTREPROSTINILINJECTABLE;INTRAVENOUS, SUBCUTANEOUS0.1MG/MLYesNo
007REMODULINTREPROSTINILINJECTABLE;INTRAVENOUS, SUBCUTANEOUS0.2MG/MLYesNo
008REMODULINTREPROSTINILINJECTABLE;INTRAVENOUS, SUBCUTANEOUS0.4MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66302-101RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-101RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-101RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-101RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-101RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-102RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-102RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-102RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-102RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-102RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-105RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-105RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-105RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-105RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-105RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-110RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-110RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-110RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-110RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-110RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-120RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-120RemodulintreprostinilUnited Therapeutics CorporationNDACurrent
66302-150Sterile Diluent for RemodulinwaterUnited Therapeutics CorporationNDACurrent
66302-150Sterile Diluent for RemodulinwaterUnited Therapeutics CorporationNDACurrent
66302-150Sterile Diluent for RemodulinwaterUnited Therapeutics CorporationNDACurrent
66302-150Sterile Diluent for RemodulinwaterUnited Therapeutics CorporationNDACurrent
66302-150Sterile Diluent for RemodulinwaterUnited Therapeutics CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74053SUPPL 2023-04-25
73711SUPPL 2023-03-08
68588SUPPL2021-09-13
68585SUPPL2021-09-13
66841SUPPL2021-03-23
66253SUPPL2021-02-17
55082SUPPL2018-08-03
55068SUPPL2018-07-31
54561SUPPL2018-06-14
54538SUPPL2018-06-12
45363SUPPL2016-09-27
21564SUPPL2015-11-18
27309SUPPL2014-12-30
42068SUPPL2014-01-16
4857SUPPL2013-10-01
36531SUPPL2013-09-27
14825SUPPL2013-09-27
27310SUPPL2013-09-26
21563SUPPL2011-10-10
27308SUPPL2011-02-14
36530SUPPL2011-02-09
4856SUPPL2010-01-15
36529SUPPL2010-01-12
14823SUPPL2008-09-19
27307SUPPL2008-09-16
14824SUPPL2008-02-14
4855SUPPL2008-02-07
27306SUPPL2006-03-23
14822SUPPL2006-03-22
27305SUPPL2006-01-30
21562ORIG2002-07-31
27304ORIG2002-05-21
14821ORIG2002-05-21