Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210491

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SYMDEKO (COPACKAGED) (IVACAFTOR; IVACAFTOR, TEZACAFTOR)
75MG;75MG, 50MG
Marketing Status: Prescription

Active Ingredient: IVACAFTOR; IVACAFTOR, TEZACAFTOR
Proprietary Name: SYMDEKO (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG;75MG, 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210491
Product Number: 002
Approval Date: Jun 21, 2019
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMDEKO (COPACKAGED) (IVACAFTOR; IVACAFTOR, TEZACAFTOR)
150MG;150MG, 100MG
Marketing Status: Prescription

Active Ingredient: IVACAFTOR; IVACAFTOR, TEZACAFTOR
Proprietary Name: SYMDEKO (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG;150MG, 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210491
Product Number: 001
Approval Date: Feb 12, 2018
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information