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Last Updated: November 4, 2024

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 one supplier. 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. Thirteen suppliers are listed for this compound. Additional details are available on the butenafine hydrochloride profile page.
Summary for 021307
Tradename:LOTRIMIN ULTRA
Applicant:Bayer Healthcare Llc
Ingredient:butenafine hydrochloride
Patents:0
Pharmacology for NDA: 021307
Suppliers and Packaging for NDA: 021307
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTRIMIN ULTRA butenafine hydrochloride CREAM;TOPICAL 021307 NDA Bayer Healthcare LLC. 11523-0082 11523-0082-1 1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR
LOTRIMIN ULTRA butenafine hydrochloride CREAM;TOPICAL 021307 NDA Bayer Healthcare LLC. 11523-0158 11523-0158-2 1 TUBE in 1 CARTON (11523-0158-2) / 30 g in 1 TUBE

Profile for product number 001

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

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