Details for New Drug Application (NDA): 211852
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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 211852
Tradename: | DEFERASIROX |
Applicant: | Cipla |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211852
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET;ORAL | 211852 | ANDA | Cipla USA Inc. | 69097-391 | 69097-391-02 | 30 TABLET, COATED in 1 BOTTLE (69097-391-02) |
DEFERASIROX | deferasirox | TABLET;ORAL | 211852 | ANDA | Cipla USA Inc. | 69097-391 | 69097-391-20 | 5 BLISTER PACK in 1 CARTON (69097-391-20) / 10 TABLET, COATED in 1 BLISTER PACK (69097-391-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Feb 11, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 360MG | ||||
Approval Date: | Feb 11, 2020 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
Approval Date: | Jun 15, 2020 | TE: | RLD: | No |
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