Details for New Drug Application (NDA): 211824
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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 211824
Tradename: | DEFERASIROX |
Applicant: | Alembic |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211824
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET;ORAL | 211824 | ANDA | Alembic Pharmaceuticals Limited | 46708-410 | 46708-410-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-410-30) |
DEFERASIROX | deferasirox | TABLET;ORAL | 211824 | ANDA | Alembic Pharmaceuticals Limited | 46708-410 | 46708-410-91 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-410-91) |
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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