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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206038

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ORKAMBI (IVACAFTOR; LUMACAFTOR)
125MG;100MG
Marketing Status: Prescription
Active Ingredient: IVACAFTOR; LUMACAFTOR
Proprietary Name: ORKAMBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206038
Product Number: 002
Approval Date: Sep 28, 2016
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ORKAMBI (IVACAFTOR; LUMACAFTOR)
125MG;200MG
Marketing Status: Prescription
Active Ingredient: IVACAFTOR; LUMACAFTOR
Proprietary Name: ORKAMBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG;200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206038
Product Number: 001
Approval Date: Jul 2, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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