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Details for NDA: 020421

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NDA 020421 describes FEMSTAT 3, which is a drug marketed by Bayer and is included in one NDA. Additional details are available on the FEMSTAT 3 profile page.

The generic ingredient in FEMSTAT 3 is butoconazole nitrate. There are six drug master file entries for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for NDA: 020421

Tradename:
FEMSTAT 3
Applicant:
Bayer
Ingredient:
butoconazole nitrate
Patents:0
Therapeutic Class:Antifungals
Glossary

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength2%
Approval Date:Dec 21, 1995TE:RLD:Yes

Expired Orange Book Patents for NDA: 020421

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer
FEMSTAT 3
butoconazole nitrate
CREAM;VAGINAL020421-001Dec 21, 19954,078,071<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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