Details for New Drug Application (NDA): 214194
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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 214194
Tradename: | DEFERASIROX |
Applicant: | Amneal |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214194
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | GRANULE;ORAL | 214194 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1702 | 69238-1702-3 | 30 PACKET in 1 CARTON (69238-1702-3) / 1 GRANULE in 1 PACKET (69238-1702-1) |
DEFERASIROX | deferasirox | GRANULE;ORAL | 214194 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1703 | 69238-1703-3 | 30 PACKET in 1 CARTON (69238-1703-3) / 1 GRANULE in 1 PACKET (69238-1703-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | 180MG | ||||
Approval Date: | Feb 9, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | 360MG | ||||
Approval Date: | Feb 9, 2021 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | 90MG | ||||
Approval Date: | Aug 2, 2021 | TE: | RLD: | No |
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