Details for New Drug Application (NDA): 210555
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The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 210555
Tradename: | DEFERASIROX |
Applicant: | Alkem Labs Ltd |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210555
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET;ORAL | 210555 | ANDA | Ascend Laboratories, LLC | 67877-552 | 67877-552-30 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-552-30) |
DEFERASIROX | deferasirox | TABLET;ORAL | 210555 | ANDA | Ascend Laboratories, LLC | 67877-552 | 67877-552-90 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-552-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Mar 30, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 360MG | ||||
Approval Date: | Mar 30, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
Approval Date: | Jul 2, 2020 | TE: | AB | RLD: | No |
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