Details for New Drug Application (NDA): 208800
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NDA 208800 describes DEFERIPRONE, which is a drug marketed by Hikma and Taro and is included in two NDAs. It is available from two 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
Summary for 208800
| Tradename: | DEFERIPRONE |
| Applicant: | Taro |
| Ingredient: | deferiprone |
| Patents: | 0 |
Pharmacology for NDA: 208800
| Mechanism of Action | Iron Chelating Activity |
Suppliers and Packaging for NDA: 208800
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFERIPRONE | deferiprone | TABLET;ORAL | 208800 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4196 | 51672-4196-1 | 100 TABLET in 1 BOTTLE (51672-4196-1) |
| DEFERIPRONE | deferiprone | TABLET;ORAL | 208800 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4237 | 51672-4237-4 | 50 TABLET in 1 BOTTLE (51672-4237-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Feb 8, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Nov 22, 2023 | TE: | AB | RLD: | No | ||||
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