Details for New Drug Application (NDA): 209279

NDA 209279 describes TRACLEER, which is a drug marketed by Actelion and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRACLEER profile page.

The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.

Summary for 209279

Tradename:	TRACLEER
Applicant:	Actelion
Ingredient:	bosentan
Patents:	2

Pharmacology for NDA: 209279

Mechanism of Action

Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 209279

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279	NDA	Actelion Pharmaceuticals US, Inc.	66215-103	66215-103-56	4 BLISTER PACK in 1 CARTON (66215-103-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-103-14)
TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279	NDA	Actelion Pharmaceuticals US, Inc.	66215-232	66215-232-56	4 BLISTER PACK in 1 CARTON (66215-232-56) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-232-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	32MG
Approval Date:	Sep 5, 2017	TE:	AB	RLD:	Yes
Patent:	7,959,945	Patent Expiration:	Dec 28, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,309,126	Patent Expiration:	May 15, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

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