Details for New Drug Application (NDA): 204286
NDA 204286 describes NAFTIN, which is a drug marketed by Legacy 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 is one drug master file entry for this compound. Two 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 is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 204286
| Tradename: | NAFTIN |
| Applicant: | Legacy |
| 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 | Legacy Pharma USA Inc. | 83107-023 | 83107-023-45 | 1 TUBE in 1 CARTON (83107-023-45) / 45 g in 1 TUBE |
| NAFTIN | naftifine hydrochloride | GEL;TOPICAL | 204286 | NDA | Legacy Pharma USA Inc. | 83107-023 | 83107-023-60 | 1 TUBE in 1 CARTON (83107-023-60) / 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: | ⤷ Start Trial | Patent Expiration: | Jan 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 31, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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