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Details for New Drug Application (NDA): 018813

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NDA 018813 describes LOTRIMIN, which is a drug marketed by Schering, Schering Plough, and Bayer Healthcare Llc, and is included in four NDAs. Additional details are available on the LOTRIMIN profile page.

The generic ingredient in LOTRIMIN is butenafine hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the butenafine hydrochloride profile page.

Summary for NDA: 018813

Therapeutic Class:Antifungals

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength1%
Approval Date:Feb 17, 1984TE:RLD:No

Expired Orange Book Patents for NDA: 018813

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
LOTION;TOPICAL018813-001Feb 17, 19843,660,577<disabled>
LOTION;TOPICAL018813-001Feb 17, 19843,839,573<disabled>
LOTION;TOPICAL018813-001Feb 17, 19843,705,172<disabled>
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