Orange Book product · Brand (NDA)
LUVOX CR
FLUVOXAMINE MALEATE
At a glance
Feb 28, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2008
18 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUVOXAMINE MALEATE
Strength
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022033
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2007LUVOXBrand (NDA)
NDA 021519 · ANI PHARMS
- 1994LUVOXBrand (NDA)
NDA 020243 · SOLVAY
- 2026FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 220328 · APPCO
- 2025FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 217024 · ANNORA PHARMA
- 2024FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 219055 · AJANTA PHARMA LTD
- 2024FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 217917 · BIONPHARMA
- 2020FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 212182 · BIONPHARMA
- 2014FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 203240 · TORRENT
- 2013FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 091482 · ACTAVIS ELIZABETH
- 2013FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 091476 · PH HEALTH
- 2006FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 075900 · CHARTWELL RX
- 2002FLUVOXAMINE MALEATEGeneric (ANDA)
ANDA 075893 · TEVA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
