Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212273

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TRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR)
50MG,37.5MG,25MG; 75MG
Marketing Status: Prescription

Active Ingredient: ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Proprietary Name: TRIKAFTA (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG,37.5MG,25MG; 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212273
Product Number: 002
Approval Date: Jun 8, 2021
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR)
100MG,75MG,50MG; 150MG
Marketing Status: Prescription

Active Ingredient: ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Proprietary Name: TRIKAFTA (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG,75MG,50MG; 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212273
Product Number: 001
Approval Date: Oct 21, 2019
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information