Details for New Drug Application (NDA): 209433
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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 209433
Tradename: | DEFERASIROX |
Applicant: | Glenmark Speclt |
Ingredient: | deferasirox |
Patents: | 0 |
Suppliers and Packaging for NDA: 209433
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 209433 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-494 | 68462-494-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-30) |
DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 209433 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-494 | 68462-494-90 | 90 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 125MG | ||||
Approval Date: | Jan 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 250MG | ||||
Approval Date: | Jan 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 6, 2020 | TE: | AB | RLD: | No |
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