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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216755

LIKMEZ (METRONIDAZOLE)
500MG/5ML
Marketing Status: Prescription
Active Ingredient: METRONIDAZOLE
Proprietary Name: LIKMEZ
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 500MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216755
Product Number: 001
Approval Date: Sep 22, 2023
Applicant Holder Full Name: SAPTALIS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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