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Last Updated: May 24, 2022

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. Nine 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
Formulation / Manufacturing:see details
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:RXDosage:TABLET;ORALStrength62.5MG
Approval Date:Nov 20, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Sep 5, 2024
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Nov 20, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Sep 5, 2024
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

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Serving leading biopharmaceutical companies globally:

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