Details for New Drug Application (NDA): 021307
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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 |
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: | OTC | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Dec 7, 2001 | TE: | RLD: | Yes |
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