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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021806

Marketing Status: Prescription
Active Ingredient: METRONIDAZOLE
Proprietary Name: VANDAZOLE
Dosage Form; Route of Administration: GEL; VAGINAL
Strength: 0.75%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: BX
Application Number: N021806
Product Number: 001
Approval Date: May 20, 2005
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
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