Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217660

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TRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR)
80MG, 60MG, 40MG;59.5MG
Marketing Status: Prescription

Active Ingredient: ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Proprietary Name: TRIKAFTA (COPACKAGED)
Dosage Form; Route of Administration: GRANULES; ORAL
Strength: 80MG, 60MG, 40MG;59.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217660
Product Number: 001
Approval Date: Apr 26, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR)
100MG, 75MG, 50MG;75MG
Marketing Status: Prescription

Active Ingredient: ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Proprietary Name: TRIKAFTA (COPACKAGED)
Dosage Form; Route of Administration: GRANULES; ORAL
Strength: 100MG, 75MG, 50MG;75MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217660
Product Number: 002
Approval Date: Apr 26, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information