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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 020670


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NDA 020670 describes MONISTAT 3 COMBINATION PACK, which is a drug marketed by Medtech Products and is included in two NDAs. It is available from two suppliers. Additional details are available on the MONISTAT 3 COMBINATION PACK profile page.

The generic ingredient in MONISTAT 3 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 020670
Tradename:MONISTAT 3 COMBINATION PACK
Applicant:Medtech Products
Ingredient:miconazole nitrate
Patents:0
Suppliers and Packaging for NDA: 020670
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670 NDA Insight Pharmaceuticals LLC 63736-017 63736-017-03 1 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE
MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670 NDA Insight Pharmaceuticals LLC 63736-019 63736-019-03 1 KIT in 1 PACKAGE, COMBINATION (63736-019-03) * 3 SUPPOSITORY in 1 KIT * 9 g in 1 TUBE

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:CREAM, SUPPOSITORY;TOPICAL, VAGINALStrength2%,200MG
Approval Date:Apr 16, 1996TE:RLD:Yes

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