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
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