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Generated: November 18, 2018

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Details for New Drug Application (NDA): 017450

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NDA 017450 describes MONISTAT 7, which is a drug marketed by Medtech Products and is included in three NDAs. It is available from one supplier. Additional details are available on the MONISTAT 7 profile page.

The generic ingredient in MONISTAT 7 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 017450
Tradename:MONISTAT 7
Applicant:Medtech Products
Ingredient:miconazole nitrate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONISTAT 7 miconazole nitrate CREAM;VAGINAL 017450 NDA Insight Pharmaceuticals 63736-003 63736-003-07 1 KIT in 1 PACKAGE, COMBINATION (63736-003-07) * .1 g in 1 TUBE, WITH APPLICATOR * .009 g in 1 TUBE
MONISTAT 7 miconazole nitrate CREAM;VAGINAL 017450 NDA Insight Pharmaceuticals 63736-023 63736-023-15 1 KIT in 1 PACKAGE, COMBINATION (63736-023-15) * 5 g in 1 TUBE, WITH APPLICATOR * 9 g in 1 TUBE

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength2%
Approval Date:Feb 15, 1991TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Express Scripts
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Fuji
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Chinese Patent Office
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