Details for New Drug Application (NDA): 214194
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NDA 214194 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Norvium Bioscience, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal, and Stevens J, and is included in thirty-three NDAs. It is available from twenty suppliers. Additional details are available on the DEFERASIROX profile page.
The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty-one 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 |
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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