Details for New Drug Application (NDA): 211383
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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 211383
Tradename: | DEFERASIROX |
Applicant: | Zydus Pharms |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211383
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET;ORAL | 211383 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1275 | 70710-1275-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1275-1) |
DEFERASIROX | deferasirox | TABLET;ORAL | 211383 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1275 | 70710-1275-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1275-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 360MG | ||||
Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
Approval Date: | Jun 15, 2020 | TE: | AB | RLD: | No |
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