Product Details for ANDA 209878
DEFERASIROX (DEFERASIROX)
125MG
Marketing Status: Prescription
250MG
Marketing Status: Prescription
500MG
Marketing Status: Prescription
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: A209878
Product Number: 001
Approval Date: Nov 20, 2019
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DEFERASIROX (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: A209878
Product Number: 001
Approval Date: Nov 20, 2019
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A209878
Product Number: 002
Approval Date: Nov 20, 2019
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DEFERASIROX (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: A209878
Product Number: 002
Approval Date: Nov 20, 2019
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A209878
Product Number: 003
Approval Date: Nov 20, 2019
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A209878
Product Number: 003
Approval Date: Nov 20, 2019
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status: Prescription
Patent and Exclusivity Information