U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 020827

MONISTAT 3 (MICONAZOLE NITRATE)
4%
Marketing Status: Over-the-counter
Active Ingredient: MICONAZOLE NITRATE
Proprietary Name: MONISTAT 3
Dosage Form; Route of Administration: CREAM; VAGINAL
Strength: 4%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020827
Product Number: 001
Approval Date: Mar 30, 1998
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
Back to Top