Details for New Drug Application (NDA): 208882
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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 208882
Tradename: | DEFERASIROX |
Applicant: | Zydus Pharms |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208882
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 208882 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1011 | 70710-1011-1 | 100 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-1) |
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 208882 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1011 | 70710-1011-3 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 125MG | ||||
Approval Date: | May 5, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 250MG | ||||
Approval Date: | May 5, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 500MG | ||||
Approval Date: | May 5, 2020 | TE: | RLD: | No |
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