Details for New Drug Application (NDA): 017494

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NDA 017494 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. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for 017494

Tradename:	MONISTAT-DERM
Applicant:	Insight Pharms
Ingredient:	miconazole nitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 017494

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Insight Pharms	MONISTAT-DERM	miconazole nitrate	CREAM;TOPICAL	017494-001	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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