Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209570

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BENZNIDAZOLE (BENZNIDAZOLE)
12.5MG
Marketing Status: Prescription

Active Ingredient: BENZNIDAZOLE
Proprietary Name: BENZNIDAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209570
Product Number: 001
Approval Date: Aug 29, 2017
Applicant Holder Full Name: CHEMO RESEARCH SL
Marketing Status:  Prescription
Patent and Exclusivity Information

BENZNIDAZOLE (BENZNIDAZOLE)
100MG
Marketing Status: Prescription

Active Ingredient: BENZNIDAZOLE
Proprietary Name: BENZNIDAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209570
Product Number: 002
Approval Date: Aug 29, 2017
Applicant Holder Full Name: CHEMO RESEARCH SL
Marketing Status:  Prescription
Patent and Exclusivity Information