Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216196

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PYRUKYND (MITAPIVAT SULFATE)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: MITAPIVAT SULFATE
Proprietary Name: PYRUKYND
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216196
Product Number: 001
Approval Date: Feb 17, 2022
Applicant Holder Full Name: AGIOS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PYRUKYND (MITAPIVAT SULFATE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: MITAPIVAT SULFATE
Proprietary Name: PYRUKYND
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216196
Product Number: 002
Approval Date: Feb 17, 2022
Applicant Holder Full Name: AGIOS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PYRUKYND (MITAPIVAT SULFATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: MITAPIVAT SULFATE
Proprietary Name: PYRUKYND
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216196
Product Number: 003
Approval Date: Feb 17, 2022
Applicant Holder Full Name: AGIOS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information