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Details for New Drug Application (NDA): 019215

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NDA 019215 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 NDA: 019215

Tradename:
FEMSTAT
Applicant:
Roche Palo
Ingredient:
butoconazole nitrate
Patents:0
Therapeutic Class:Antifungals

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;VAGINALStrength2%
Approval Date:Nov 25, 1985TE:RLD:No

Expired Orange Book Patents for NDA: 019215

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
FEMSTAT
butoconazole nitrate
CREAM;VAGINAL019215-001Nov 25, 19854,078,071► subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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