Details for New Drug Application (NDA): 216229
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NDA 216229 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Ichnos, Sun Pharm, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal Hlthcare Uk, and Stevens J, and is included in twenty-nine NDAs. It is available from nineteen 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 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 suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 216229
| Tradename: | DEFERASIROX |
| Applicant: | Annora Pharma |
| Ingredient: | deferasirox |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216229
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFERASIROX | deferasirox | GRANULE;ORAL | 216229 | ANDA | Camber Pharmaceuticals, Inc. | 31722-029 | 31722-029-32 | 30 PACKET in 1 CARTON (31722-029-32) / 1 GRANULE in 1 PACKET |
| DEFERASIROX | deferasirox | GRANULE;ORAL | 216229 | ANDA | Camber Pharmaceuticals, Inc. | 31722-030 | 31722-030-32 | 30 PACKET in 1 CARTON (31722-030-32) / 1 GRANULE in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 180MG | ||||
| Approval Date: | Sep 22, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 360MG | ||||
| Approval Date: | Sep 22, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 90MG | ||||
| Approval Date: | Mar 16, 2023 | TE: | AB | RLD: | No | ||||
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