Details for New Drug Application (NDA): 209570
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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 |
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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