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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215559

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SOHONOS (PALOVAROTENE)
1MG
Marketing Status: Prescription
Active Ingredient: PALOVAROTENE
Proprietary Name: SOHONOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215559
Product Number: 001
Approval Date: Aug 16, 2023
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SOHONOS (PALOVAROTENE)
1.5MG
Marketing Status: Prescription
Active Ingredient: PALOVAROTENE
Proprietary Name: SOHONOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215559
Product Number: 002
Approval Date: Aug 16, 2023
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SOHONOS (PALOVAROTENE)
2.5MG
Marketing Status: Prescription
Active Ingredient: PALOVAROTENE
Proprietary Name: SOHONOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215559
Product Number: 003
Approval Date: Aug 16, 2023
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SOHONOS (PALOVAROTENE)
5MG
Marketing Status: Prescription
Active Ingredient: PALOVAROTENE
Proprietary Name: SOHONOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215559
Product Number: 004
Approval Date: Aug 16, 2023
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SOHONOS (PALOVAROTENE)
10MG
Marketing Status: Prescription
Active Ingredient: PALOVAROTENE
Proprietary Name: SOHONOS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215559
Product Number: 005
Approval Date: Aug 16, 2023
Applicant Holder Full Name: IPSEN BIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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