Details for New Drug Application (NDA): 209279
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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.
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.
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 5, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY | ||||||||
| 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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