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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214622

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TRUSELTIQ (INFIGRATINIB PHOSPHATE)
25MG
Marketing Status: Prescription
Active Ingredient: INFIGRATINIB PHOSPHATE
Proprietary Name: TRUSELTIQ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214622
Product Number: 001
Approval Date: May 28, 2021
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Prescription
Patent and Exclusivity Information
TRUSELTIQ (INFIGRATINIB PHOSPHATE)
100MG
Marketing Status: Prescription
Active Ingredient: INFIGRATINIB PHOSPHATE
Proprietary Name: TRUSELTIQ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214622
Product Number: 002
Approval Date: May 28, 2021
Applicant Holder Full Name: HELSINN HEALTHCARE SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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