Details for New Drug Application (NDA): 019359

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NDA 019359 describes FEMSTAT, which is a drug marketed by Roche Palo and Bayer and is included in three NDAs. Additional details are available on the FEMSTAT profile page.

The generic ingredient in FEMSTAT is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for 019359

Tradename:	FEMSTAT
Applicant:	Roche Palo
Ingredient:	butoconazole nitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;VAGINAL			Strength	100MG
Approval Date:	Nov 25, 1985	TE:		RLD:	No

Expired US Patents for NDA 019359

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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