Details for New Drug Application (NDA): 214429
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NDA 214429 describes FEXINIDAZOLE, which is a drug marketed by Sanofi and is included in one NDA. It is available from one supplier. Additional details are available on the FEXINIDAZOLE profile page.
The generic ingredient in FEXINIDAZOLE is fexinidazole. One supplier is listed for this compound. Additional details are available on the fexinidazole profile page.
The generic ingredient in FEXINIDAZOLE is fexinidazole. One supplier is listed for this compound. Additional details are available on the fexinidazole profile page.
Summary for 214429
| Tradename: | FEXINIDAZOLE |
| Applicant: | Sanofi |
| Ingredient: | fexinidazole |
| Patents: | 0 |
Pharmacology for NDA: 214429
Suppliers and Packaging for NDA: 214429
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEXINIDAZOLE | fexinidazole | TABLET;ORAL | 214429 | NDA | Sanofi-Aventis U.S. LLC | 0024-4512 | 0024-4512-14 | 14 TABLET in 1 DOSE PACK (0024-4512-14) |
| FEXINIDAZOLE | fexinidazole | TABLET;ORAL | 214429 | NDA | Sanofi-Aventis U.S. LLC | 0024-4512 | 0024-4512-24 | 24 TABLET in 1 DOSE PACK (0024-4512-24) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jul 16, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF BOTH THE FIRST-STAGE (HEMOLYMPHATIC) AND SECOND-STAGE (MENINGOENCEPHALITIC) HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE IN PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 20 KG | ||||||||
| Regulatory Exclusivity Expiration: | Jul 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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