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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 019881

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NDA 019881 describes BUTOCONAZOLE NITRATE, which is a drug marketed by Padagis Us and is included in one NDA. Additional details are available on the BUTOCONAZOLE NITRATE profile page.

The generic ingredient in BUTOCONAZOLE NITRATE 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 019881

Tradename:	BUTOCONAZOLE NITRATE
Applicant:	Padagis Us
Ingredient:	butoconazole nitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;VAGINAL			Strength	2%
Approval Date:	Feb 7, 1997	TE:		RLD:	No

Expired US Patents for NDA 019881

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	4,078,071	⤷ Get Started Free
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	5,993,856	⤷ Get Started Free
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	4,551,148	⤷ Get Started Free
Padagis Us	BUTOCONAZOLE NITRATE	butoconazole nitrate	CREAM;VAGINAL	019881-001	Feb 7, 1997	5,266,329	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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