Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203560

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DEFERASIROX (DEFERASIROX)
125MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203560
Product Number: 001
Approval Date: Jan 26, 2016
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEFERASIROX (DEFERASIROX)
250MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203560
Product Number: 002
Approval Date: Jan 26, 2016
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEFERASIROX (DEFERASIROX)
500MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203560
Product Number: 003
Approval Date: Jan 26, 2016
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information