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. Three suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 019599
Tradename: | NAFTIN |
Applicant: | Sebela Ireland Ltd |
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| DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | NAFTIN | naftifine hydrochloride | CREAM;TOPICAL | 019599-001 | Feb 29, 1988 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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