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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209299

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TAVALISSE (FOSTAMATINIB DISODIUM)
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: FOSTAMATINIB DISODIUM
Proprietary Name: TAVALISSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209299
Product Number: 001
Approval Date: Apr 17, 2018
Applicant Holder Full Name: RIGEL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TAVALISSE (FOSTAMATINIB DISODIUM)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: FOSTAMATINIB DISODIUM
Proprietary Name: TAVALISSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209299
Product Number: 002
Approval Date: Apr 17, 2018
Applicant Holder Full Name: RIGEL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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