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Generated: January 19, 2019

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Details for New Drug Application (NDA): 208276

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NDA 208276 describes REMODULIN, which is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the REMODULIN profile page.

The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 208276
Tradename:REMODULIN
Applicant:United Therap
Ingredient:treprostinil
Patents:4

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUS, SUBCUTANEOUSStrength20MG/20ML (1MG/ML)
Approval Date:Jul 30, 2018TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Dec 16, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Dec 15, 2028Product Flag?Substance Flag?YDelist Request?

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