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Last Updated: November 4, 2024

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.
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:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Aug 29, 2017TE: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:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 29, 2017TE: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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