Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211358

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ORKAMBI (IVACAFTOR; LUMACAFTOR)
94MG/PACKET;75MG/PACKET
Marketing Status: Prescription

Active Ingredient: IVACAFTOR; LUMACAFTOR
Proprietary Name: ORKAMBI
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 94MG/PACKET;75MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211358
Product Number: 003
Approval Date: Sep 2, 2022
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ORKAMBI (IVACAFTOR; LUMACAFTOR)
125MG/PACKET;100MG/PACKET
Marketing Status: Prescription

Active Ingredient: IVACAFTOR; LUMACAFTOR
Proprietary Name: ORKAMBI
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 125MG/PACKET;100MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211358
Product Number: 001
Approval Date: Aug 7, 2018
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ORKAMBI (IVACAFTOR; LUMACAFTOR)
188MG/PACKET;150MG/PACKET
Marketing Status: Prescription

Active Ingredient: IVACAFTOR; LUMACAFTOR
Proprietary Name: ORKAMBI
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 188MG/PACKET;150MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211358
Product Number: 002
Approval Date: Aug 7, 2018
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information