Orange Book product · Brand (NDA)
LUVOX
FLUVOXAMINE MALEATE
At a glance
Dec 05, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 05, 1994
32 yr ago
Today
Pharmaceutical detail
Active ingredient
FLUVOXAMINE MALEATE
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020243
Product number
001
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.
- 2008LUVOX CRBrand (NDA)
NDA 022033 · JAZZ PHARMS
- 2007LUVOXBrand (NDA)
NDA 021519 · ANI PHARMS
- 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.
