Details for New Drug Application (NDA): 021290

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NDA 021290 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 021290

Tradename:	TRACLEER
Applicant:	Actelion
Ingredient:	bosentan
Patents:	0

Pharmacology for NDA: 021290

Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 021290

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-101	66215-101-03	10 BLISTER PACK in 1 CARTON (66215-101-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
TRACLEER	bosentan	TABLET;ORAL	021290	NDA	Actelion Pharmaceuticals US, Inc.	66215-101	66215-101-06	1 BOTTLE, PLASTIC in 1 CARTON (66215-101-06) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	62.5MG
Approval Date:	Nov 20, 2001	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Nov 20, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021290

Show entries

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	⤷ Try for Free	⤷ Try for Free
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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