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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Moodys
Teva
Farmers Insurance
Argus Health
Citi
Fuji
Healthtrust
Johnson and Johnson

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021308

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NDA 021308 describes MONISTAT 1 COMBINATION PACK, which is a drug marketed by Medtech Products and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MONISTAT 1 COMBINATION PACK profile page.

The generic ingredient in MONISTAT 1 COMBINATION PACK 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 021308
Tradename:MONISTAT 1 COMBINATION PACK
Applicant:Medtech Products
Ingredient:miconazole nitrate
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308 NDA Insight Pharmaceuticals 63736-001 N 63736-001-01
MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 021308 NDA Insight Pharmaceuticals 63736-013 N 63736-013-30

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM, SUPPOSITORY;TOPICAL, VAGINALStrength2%,1.2GM
Approval Date:Jun 29, 2001TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 28, 2020Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Moodys
US Department of Justice
Fuji
Healthtrust
McKinsey
US Army
Harvard Business School
Fish and Richardson

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