FDA Orange Book · active-ingredient family
Fluvoxamine maleate
Fluvoxamine maleate is approved as 3 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LUVOX CR · NDA 022033
3
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUVOX CRRLD×2 | JAZZ PHARMS | NDA 022033 | — | Feb 28, 2008 | |
| LUVOXRLD×3 | ANI PHARMS | NDA 021519 | AB | Dec 20, 2007 | |
| LUVOXRLD×4 | SOLVAY | NDA 020243 | — | Dec 05, 1994 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE×2 | APPCO | ANDA 220328 | AB | Apr 30, 2026 | |
| FLUVOXAMINE MALEATE×2 | ANNORA PHARMA | ANDA 217024 | AB | Jul 30, 2025 | |
| FLUVOXAMINE MALEATE×2 | AJANTA PHARMA LTD | ANDA 219055 | AB | Oct 17, 2024 | |
| FLUVOXAMINE MALEATE×3 | BIONPHARMA | ANDA 217917 | AB | Jan 22, 2024 | |
| FLUVOXAMINE MALEATE×2 | BIONPHARMA | ANDA 212182 | AB | Sep 16, 2020 | |
| FLUVOXAMINE MALEATE×2 | TORRENT | ANDA 203240 | — | Oct 31, 2014 | |
| FLUVOXAMINE MALEATE×2 | ACTAVIS ELIZABETH | ANDA 091482 | AB | Apr 23, 2013 | |
| FLUVOXAMINE MALEATE×2 | PH HEALTH | ANDA 091476 | AB | Mar 13, 2013 | |
| FLUVOXAMINE MALEATE×3 | CHARTWELL RX | ANDA 075900 | — | Feb 23, 2006 | |
| FLUVOXAMINE MALEATE×3 | TEVA | ANDA 075893 | — | Sep 10, 2002 | |
| FLUVOXAMINE MALEATE×3 | SUN PHARM INDUSTRIES | ANDA 076125 | — | Apr 29, 2002 | |
| FLUVOXAMINE MALEATE×2 | MYLAN | ANDA 075950 | — | Oct 15, 2001 | |
| FLUVOXAMINE MALEATE×3 | APOTEX | ANDA 075902 | AB | May 07, 2001 | |
| FLUVOXAMINE MALEATE×3 | HERITAGE PHARMA | ANDA 075894 | — | Apr 18, 2001 | |
| FLUVOXAMINE MALEATE×3 | ANI PHARMS | ANDA 075898 | — | Mar 12, 2001 | |
| FLUVOXAMINE MALEATE×3 | ANI PHARMS | ANDA 075897 | — | Jan 25, 2001 | |
| FLUVOXAMINE MALEATE×3 | SYNTHON PHARMS | ANDA 075899 | — | Jan 17, 2001 | |
| FLUVOXAMINE MALEATE×3 | UPSHER SMITH LABS | ANDA 075887 | — | Jan 05, 2001 | |
| FLUVOXAMINE MALEATE×3 | ACTAVIS ELIZABETH | ANDA 075901 | — | Dec 28, 2000 | |
| FLUVOXAMINE MALEATE×3 | AIPING PHARM INC | ANDA 075888 | AB | Nov 29, 2000 | |
| FLUVOXAMINE MALEATE×3 | QUAGEN | ANDA 075889 | — | Nov 29, 2000 |
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.
Fluvoxamine maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
