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