Details for New Drug Application (NDA): 019599
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The generic ingredient in NAFTIN is naftifine hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 019599
| Tradename: | NAFTIN |
| Applicant: | Legacy Pharma |
| Ingredient: | naftifine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 29, 1988 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | Jan 13, 2012 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 019599
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Legacy Pharma | NAFTIN | naftifine hydrochloride | CREAM;TOPICAL | 019599-001 | Feb 29, 1988 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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