Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217729

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BOSULIF (BOSUTINIB MONOHYDRATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217729
Product Number: 001
Approval Date: Sep 26, 2023
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

BOSULIF (BOSUTINIB MONOHYDRATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217729
Product Number: 002
Approval Date: Sep 26, 2023
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information