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Details for New Drug Application (NDA): 021290

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NDA 021290 describes TRACLEER, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the TRACLEER profile page.

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

Summary for NDA: 021290

Actelion Pharms Ltd
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021290

Suppliers and Packaging for NDA: 021290

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength62.5MG
Approval Date:Nov 20, 2001TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Nov 20, 2001TE:RLD:Yes

Expired Orange Book Patents for NDA: 021290

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd
TABLET;ORAL021290-001Nov 20, 20015,292,740► subscribe
Actelion Pharms Ltd
TABLET;ORAL021290-002Nov 20, 20015,292,740► subscribe
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