Details for New Drug Application (NDA): 210060
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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 210060
Tradename: | DEFERASIROX |
Applicant: | Alembic |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210060
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 210060 | ANDA | Alembic Pharmaceuticals Limited | 46708-324 | 46708-324-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30) |
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 210060 | ANDA | Alembic Pharmaceuticals Limited | 46708-325 | 46708-325-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-325-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 125MG | ||||
Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 250MG | ||||
Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 500MG | ||||
Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No |
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