Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021882

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EXJADE (DEFERASIROX)
125MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: EXJADE
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021882
Product Number: 001
Approval Date: Nov 2, 2005
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

EXJADE (DEFERASIROX)
250MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: EXJADE
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021882
Product Number: 002
Approval Date: Nov 2, 2005
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

EXJADE (DEFERASIROX)
500MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: EXJADE
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021882
Product Number: 003
Approval Date: Nov 2, 2005
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information