Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022033

Expand all

LUVOX CR (FLUVOXAMINE MALEATE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N022033
Product Number: 001
Approval Date: Feb 28, 2008
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

LUVOX CR (FLUVOXAMINE MALEATE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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: N022033
Product Number: 002
Approval Date: Feb 28, 2008
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
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