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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200923

GYNAZOLE-1 (BUTOCONAZOLE NITRATE)
2%
Marketing Status: Prescription
Active Ingredient: BUTOCONAZOLE NITRATE
Proprietary Name: GYNAZOLE-1
Dosage Form; Route of Administration: CREAM; VAGINAL
Strength: 2%
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A200923
Product Number: 001
Approval Date: May 18, 2012
Applicant Holder Full Name: PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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