Details for New Drug Application (NDA): 220132
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NDA 220132 describes DEFERIPRONE, which is a drug marketed by Hikma, Senores Pharms, and Taro, and is included in three NDAs. It is available from three suppliers. Additional details are available on the DEFERIPRONE profile page.
The generic ingredient in DEFERIPRONE is deferiprone. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
The generic ingredient in DEFERIPRONE is deferiprone. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
Summary for 220132
| Tradename: | DEFERIPRONE |
| Applicant: | Senores Pharms |
| Ingredient: | deferiprone |
| Patents: | 0 |
Pharmacology for NDA: 220132
| Mechanism of Action | Iron Chelating Activity |
Suppliers and Packaging for NDA: 220132
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFERIPRONE | deferiprone | TABLET;ORAL | 220132 | ANDA | DR. REDDY'S LABORATORIES, INC. | 75907-348 | 75907-348-50 | 50 TABLET, COATED in 1 BOTTLE (75907-348-50) |
| DEFERIPRONE | deferiprone | TABLET;ORAL | 220132 | ANDA | DR. REDDY'S LABORATORIES, INC. | 75907-349 | 75907-349-01 | 100 TABLET, COATED in 1 BOTTLE (75907-349-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Dec 11, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Dec 11, 2025 | TE: | AB | RLD: | No | ||||
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