Details for New Drug Application (NDA): 209878
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NDA 209878 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 209878
| Tradename: | DEFERASIROX |
| Applicant: | Msn |
| Ingredient: | deferasirox |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209878
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 209878 | ANDA | Dr. Reddy's Laboratories Inc | 43598-854 | 43598-854-05 | 500 TABLET, FOR SUSPENSION in 1 BOTTLE (43598-854-05) |
| DEFERASIROX | deferasirox | TABLET, FOR SUSPENSION;ORAL | 209878 | ANDA | Dr. Reddy's Laboratories Inc | 43598-854 | 43598-854-30 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (43598-854-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 125MG | ||||
| Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 250MG | ||||
| Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No | ||||
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