Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214474

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DEFERASIROX (DEFERASIROX)
90MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214474
Product Number: 001
Approval Date: Oct 16, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DEFERASIROX (DEFERASIROX)
180MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214474
Product Number: 002
Approval Date: Oct 16, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DEFERASIROX (DEFERASIROX)
360MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 360MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214474
Product Number: 003
Approval Date: Oct 16, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information