Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209203

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DUZALLO (ALLOPURINOL; LESINURAD)
200MG;200MG Marketing Status: Prescription

Active Ingredient: ALLOPURINOL; LESINURAD
Proprietary Name: DUZALLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209203
Product Number: 001
Approval Date: Aug 18, 2017
Applicant Holder Full Name: IRONWOOD PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DUZALLO (ALLOPURINOL; LESINURAD)
300MG;200MG Marketing Status: Prescription

Active Ingredient: ALLOPURINOL; LESINURAD
Proprietary Name: DUZALLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG;200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209203
Product Number: 002
Approval Date: Aug 18, 2017
Applicant Holder Full Name: IRONWOOD PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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