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.
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 |
| 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: | RX | Dosage: | TABLET;ORAL | Strength | 62.5MG | ||||
| Approval Date: | Nov 20, 2001 | TE: | AB | RLD: | 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: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Nov 20, 2001 | TE: | AB | RLD: | 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) | ||||||||
Expired US Patents for NDA 021290
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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