Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210727

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DEFERASIROX (DEFERASIROX)
90MG
Marketing Status: Discontinued

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210727
Product Number: 001
Approval Date: Dec 27, 2019
Applicant Holder Full Name: JEROME STEVENS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DEFERASIROX (DEFERASIROX)
180MG
Marketing Status: Discontinued

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210727
Product Number: 003
Approval Date: Jun 15, 2020
Applicant Holder Full Name: JEROME STEVENS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DEFERASIROX (DEFERASIROX)
360MG
Marketing Status: Discontinued

Active Ingredient: DEFERASIROX
Proprietary Name: DEFERASIROX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 360MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210727
Product Number: 002
Approval Date: Dec 27, 2019
Applicant Holder Full Name: JEROME STEVENS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information