NDA 208276

UNITED THERAP

FDA Drug Application

Application #208276

Documents

• Label: 2018-07-31
• Letter: 2018-08-03
• Review: 2018-07-30

Application Sponsors

NDA 208276

UNITED THERAP

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	20MG/20ML (1MG/ML)	0	REMODULIN	TREPROSTINIL
002	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	50MG/20ML (2.5MG/ML)	0	REMODULIN	TREPROSTINIL
003	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	100MG/20ML (5MG/ML)	0	REMODULIN	TREPROSTINIL
004	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	200MG/20ML (10MG/ML)	0	REMODULIN	TREPROSTINIL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2018-07-30

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

UNITED THERAP

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            [companyName] => UNITED THERAP
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            [products] => [{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"20MG\/20ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"50MG\/20ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"100MG\/20ML (5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REMODULIN","activeIngredients":"TREPROSTINIL","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
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            [supplements] => 
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        )

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