Details for New Drug Application (NDA): 213374
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NDA 213374 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Cipla, Epic Pharma Llc, MSN, Pharmobedient, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Jubilant Generics, Piramal, and Stevens J, and is included in thirty-five 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 213374
| Tradename: | DEFERASIROX |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | deferasirox |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213374
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFERASIROX | deferasirox | GRANULE;ORAL | 213374 | ANDA | Ascend Laboratories, LLC | 67877-675 | 67877-675-84 | 30 PACKET in 1 CARTON (67877-675-84) / 1 GRANULE in 1 PACKET (67877-675-71) |
| DEFERASIROX | deferasirox | GRANULE;ORAL | 213374 | ANDA | Ascend Laboratories, LLC | 67877-676 | 67877-676-84 | 30 PACKET in 1 CARTON (67877-676-84) / 1 GRANULE in 1 PACKET (67877-676-72) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 90MG | ||||
| Approval Date: | Jul 14, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 180MG | ||||
| Approval Date: | Jul 14, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 360MG | ||||
| Approval Date: | Jul 14, 2020 | TE: | AB | RLD: | No | ||||
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