Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215498

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BYLVAY (ODEVIXIBAT)
0.4MG
Marketing Status: Prescription
Active Ingredient: ODEVIXIBAT
Proprietary Name: BYLVAY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215498
Product Number: 002
Approval Date: Jul 20, 2021
Applicant Holder Full Name: ALBIREO AB
Marketing Status:  Prescription
Patent and Exclusivity Information
BYLVAY (ODEVIXIBAT)
1.2MG
Marketing Status: Prescription
Active Ingredient: ODEVIXIBAT
Proprietary Name: BYLVAY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1.2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215498
Product Number: 004
Approval Date: Jul 20, 2021
Applicant Holder Full Name: ALBIREO AB
Marketing Status:  Prescription
Patent and Exclusivity Information
BYLVAY (ODEVIXIBAT)
0.2MG
Marketing Status: Prescription
Active Ingredient: ODEVIXIBAT
Proprietary Name: BYLVAY
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 0.2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215498
Product Number: 001
Approval Date: Jul 20, 2021
Applicant Holder Full Name: ALBIREO AB
Marketing Status:  Prescription
Patent and Exclusivity Information
BYLVAY (ODEVIXIBAT)
0.6MG
Marketing Status: Prescription
Active Ingredient: ODEVIXIBAT
Proprietary Name: BYLVAY
Dosage Form; Route of Administration: CAPSULE, PELLETS; ORAL
Strength: 0.6MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215498
Product Number: 003
Approval Date: Jul 20, 2021
Applicant Holder Full Name: ALBIREO AB
Marketing Status:  Prescription
Patent and Exclusivity Information

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