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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217564

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FRUZAQLA (FRUQUINTINIB)
1MG
Marketing Status: Prescription
Active Ingredient: FRUQUINTINIB
Proprietary Name: FRUZAQLA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217564
Product Number: 001
Approval Date: Nov 8, 2023
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FRUZAQLA (FRUQUINTINIB)
5MG
Marketing Status: Prescription
Active Ingredient: FRUQUINTINIB
Proprietary Name: FRUZAQLA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217564
Product Number: 002
Approval Date: Nov 8, 2023
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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