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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203808

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TINIDAZOLE (TINIDAZOLE)
250MG
Marketing Status: Prescription
Active Ingredient: TINIDAZOLE
Proprietary Name: TINIDAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203808
Product Number: 001
Approval Date: Aug 4, 2015
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
TINIDAZOLE (TINIDAZOLE)
500MG
Marketing Status: Prescription
Active Ingredient: TINIDAZOLE
Proprietary Name: TINIDAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203808
Product Number: 002
Approval Date: Aug 4, 2015
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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