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Boehringer Ingelheim
Harvard Business School

Last Updated: May 30, 2023

Details for New Drug Application (NDA): 020827

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NDA 020827 describes MONISTAT 3, which is a drug marketed by Medtech Products and is included in four NDAs. It is available from one supplier. Additional details are available on the MONISTAT 3 profile page.

The generic ingredient in MONISTAT 3 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 020827
Tradename:MONISTAT 3
Applicant:Medtech Products
Ingredient:miconazole nitrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020827
Suppliers and Packaging for NDA: 020827
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONISTAT 3 miconazole nitrate CREAM;VAGINAL 020827 NDA Insight Pharmaceuticals LLC 63736-015 63736-015-18 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength4%
Approval Date:Mar 30, 1998TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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