Details for New Drug Application (NDA): 209279
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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: | ⤷ Sign Up | Patent Expiration: | Dec 28, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 15, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
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