Details for New Drug Application (NDA): 210038
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NDA 210038 describes NAFTIFINE HYDROCHLORIDE, which is a drug marketed by Amneal, Taro, and Xiromed, and is included in six NDAs. It is available from two suppliers. Additional details are available on the NAFTIFINE HYDROCHLORIDE profile page.
The generic ingredient in NAFTIFINE HYDROCHLORIDE is naftifine hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
The generic ingredient in NAFTIFINE HYDROCHLORIDE is naftifine hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 210038
| Tradename: | NAFTIFINE HYDROCHLORIDE |
| Applicant: | Xiromed |
| Ingredient: | naftifine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 210038 | ANDA | Xiromed, LLC | 70700-161 | 70700-161-17 | 1 TUBE in 1 CARTON (70700-161-17) / 60 g in 1 TUBE |
| NAFTIFINE HYDROCHLORIDE | naftifine hydrochloride | CREAM;TOPICAL | 210038 | ANDA | Xiromed, LLC | 70700-161 | 70700-161-18 | 1 TUBE in 1 CARTON (70700-161-18) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | Sep 22, 2020 | TE: | AB | RLD: | No | ||||
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