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Details for New Drug Application (NDA): 209570
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NDA 209570 describes BENZNIDAZOLE, which is a drug marketed by Chemo Research Sl and is included in one NDA. It is available from one supplier. Additional details are available on the BENZNIDAZOLE profile page.
The generic ingredient in BENZNIDAZOLE is benznidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benznidazole profile page.
The generic ingredient in BENZNIDAZOLE is benznidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benznidazole profile page.
Summary for 209570
| Tradename: | BENZNIDAZOLE |
| Applicant: | Chemo Research Sl |
| Ingredient: | benznidazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209570
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENZNIDAZOLE | benznidazole | TABLET;ORAL | 209570 | NDA | Exeltis USA, Inc. | 0642-7463 | 0642-7463-12 | 1 BOTTLE in 1 CARTON (0642-7463-12) > 100 TABLET in 1 BOTTLE |
| BENZNIDAZOLE | benznidazole | TABLET;ORAL | 209570 | NDA | Exeltis USA, Inc. | 0642-7464 | 0642-7464-10 | 1 BOTTLE in 1 CARTON (0642-7464-10) > 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Aug 29, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR USE IN CHILDREN AGES 2 TO 12 YEARS OLD WITH CHAGAS DISEASE | ||||||||
| Regulatory Exclusivity Expiration: | Aug 29, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 29, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR USE IN CHILDREN AGES 2 TO 12 YEARS OLD WITH CHAGAS DISEASE | ||||||||
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