Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 204286

2% Marketing Status: Prescription

Proprietary Name: NAFTIN
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204286
Product Number: 001
Approval Date: Jun 27, 2013
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English