Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021261

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MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE)
2%,4%
Marketing Status: Over-the-counter

Active Ingredient: MICONAZOLE NITRATE
Proprietary Name: MONISTAT 3 COMBINATION PACK
Dosage Form; Route of Administration: CREAM; TOPICAL, VAGINAL
Strength: 2%,4%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021261
Product Number: 003
Approval Date: Jun 17, 2003
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

MONISTAT 3 COMBINATION PACK (PREFILLED) (MICONAZOLE NITRATE)
2%,4%
Marketing Status: Over-the-counter

Active Ingredient: MICONAZOLE NITRATE
Proprietary Name: MONISTAT 3 COMBINATION PACK (PREFILLED)
Dosage Form; Route of Administration: CREAM; TOPICAL, VAGINAL
Strength: 2%,4%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021261
Product Number: 001
Approval Date: Feb 2, 2001
Applicant Holder Full Name: MEDTECH PRODUCTS INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information