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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Daiichi Sankyo
Boehringer Ingelheim
Express Scripts
Baxter
Fuji
Chubb
Healthtrust
Chinese Patent Office

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018040

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NDA 018040 describes MONISTAT, which is a drug marketed by Janssen Pharma, Medtech Products, Personal Prods, and Insight Pharms, and is included in twelve NDAs. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the MONISTAT profile page.

The generic ingredient in MONISTAT 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 018040
Tradename:MONISTAT
Applicant:Janssen Pharma
Ingredient:miconazole
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired US Patents for NDA 018040

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Fish and Richardson
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