Details for New Drug Application (NDA): 204286
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NDA 204286 describes NAFTIN, which is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAFTIN profile page.
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.
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 204286
| Tradename: | NAFTIN |
| Applicant: | Sebela Ireland Ltd |
| Ingredient: | naftifine hydrochloride |
| Patents: | 6 |
Suppliers and Packaging for NDA: 204286
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286 | NDA | Sebela Pharmaceuticals Inc. | 54766-772 | 54766-772-45 | 1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE |
| NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286 | NDA | Sebela Pharmaceuticals Inc. | 54766-772 | 54766-772-60 | 1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 2% | ||||
| Approval Date: | Jun 27, 2013 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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