Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 008720

LEVO-DROMORAN (LEVORPHANOL TARTRATE)
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: LEVORPHANOL TARTRATE
Proprietary Name: LEVO-DROMORAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N008720
Product Number: 001
Approval Date: Dec 19, 1991
Applicant Holder Full Name: VALEANT PHARMACEUTICALS INTERNATIONAL
Marketing Status:  Discontinued
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