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Last Updated: November 4, 2024

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. 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. Fifty-one 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

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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