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Details for New Drug Application (NDA): 021307

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NDA 021307 describes LOTRIMIN ULTRA, which is a drug marketed by Bayer Healthcare Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the LOTRIMIN ULTRA profile page.

The generic ingredient in LOTRIMIN ULTRA 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: 021307

Bayer Healthcare Llc
butenafine hydrochloride
Therapeutic Class:Antifungals

Suppliers and Packaging for NDA: 021307

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
butenafine hydrochloride
CREAM;TOPICAL 021307 NDA Bayer Healthcare LLC 11523-4338 11523-4338-1 1 TUBE in 1 CARTON (11523-4338-1) > 12 g in 1 TUBE
butenafine hydrochloride
CREAM;TOPICAL 021307 NDA Bayer Healthcare LLC 11523-4338 11523-4338-2 1 TUBE in 1 CARTON (11523-4338-2) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 7, 2001TE:RLD:Yes

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