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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212608

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AYVAKIT (AVAPRITINIB)
25MG
Marketing Status: Prescription
Active Ingredient: AVAPRITINIB
Proprietary Name: AYVAKIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212608
Product Number: 004
Approval Date: Jun 16, 2021
Applicant Holder Full Name: BLUEPRINT MEDICINES CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
AYVAKIT (AVAPRITINIB)
50MG
Marketing Status: Prescription
Active Ingredient: AVAPRITINIB
Proprietary Name: AYVAKIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212608
Product Number: 005
Approval Date: Jun 16, 2021
Applicant Holder Full Name: BLUEPRINT MEDICINES CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
AYVAKIT (AVAPRITINIB)
100MG
Marketing Status: Prescription
Active Ingredient: AVAPRITINIB
Proprietary Name: AYVAKIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212608
Product Number: 001
Approval Date: Jan 9, 2020
Applicant Holder Full Name: BLUEPRINT MEDICINES CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
AYVAKIT (AVAPRITINIB)
200MG
Marketing Status: Prescription
Active Ingredient: AVAPRITINIB
Proprietary Name: AYVAKIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212608
Product Number: 002
Approval Date: Jan 9, 2020
Applicant Holder Full Name: BLUEPRINT MEDICINES CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
AYVAKIT (AVAPRITINIB)
300MG
Marketing Status: Prescription
Active Ingredient: AVAPRITINIB
Proprietary Name: AYVAKIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212608
Product Number: 003
Approval Date: Jan 9, 2020
Applicant Holder Full Name: BLUEPRINT MEDICINES CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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