Details for New Drug Application (NDA): 203560
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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 203560
Tradename: | DEFERASIROX |
Applicant: | Actavis Elizabeth |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203560
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 203560 | ANDA | Actavis Pharma, Inc. | 45963-454 | 45963-454-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-454-30) |
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 203560 | ANDA | Actavis Pharma, Inc. | 45963-455 | 45963-455-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-455-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 125MG | ||||
Approval Date: | Jan 26, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 250MG | ||||
Approval Date: | Jan 26, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 26, 2016 | TE: | AB | RLD: | No |
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