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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 017739


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NDA 017739 describes MONISTAT-DERM, which is a drug marketed by Insight Pharms and is included in two NDAs. Additional details are available on the MONISTAT-DERM profile page.

The generic ingredient in MONISTAT-DERM 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 017739
Tradename:MONISTAT-DERM
Applicant:Insight Pharms
Ingredient:miconazole nitrate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired US Patents for NDA 017739

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Insight Pharms MONISTAT-DERM miconazole nitrate LOTION;TOPICAL 017739-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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