FDA Orange Book · active-ingredient family
Nabumetone
Nabumetone is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RELAFEN · NDA 019583
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RELAFENRLD×2 | SMITHKLINE BEECHAM | NDA 019583 | — | Dec 24, 1991 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NABUMETONE×2 | NOVITIUM PHARMA | ANDA 219118 | AB | Jan 07, 2025 | |
| NABUMETONE×3 | LGM PHARMA | ANDA 203166 | — | Aug 30, 2019 | |
| NABUMETONE×2 | MPP PHARMA | ANDA 090427 | — | Dec 30, 2011 | |
| NABUMETONE×2 | WATSON LABS | ANDA 091083 | AB | Jun 13, 2011 | |
| NABUMETONE×2 | ANNORA PHARMA | ANDA 090445 | AB | Jan 12, 2011 | |
| NABUMETONE×2 | AUROBINDO PHARMA USA | ANDA 090516 | — | Jul 12, 2010 | |
| NABUMETONE×2 | OXFORD PHARMS | ANDA 079093 | — | Feb 27, 2009 | |
| NABUMETONE×2 | SCIEGEN PHARMS | ANDA 078420 | AB | Sep 24, 2008 | |
| NABUMETONE×2 | INVAGEN PHARMS | ANDA 078671 | AB | Mar 07, 2008 | |
| NABUMETONE×2 | CHARTWELL MOLECULES | ANDA 076009 | AB | Jan 24, 2003 | |
| NABUMETONE×2 | CHARTWELL RX | ANDA 075280 | AB | Feb 25, 2002 | |
| NABUMETONE×2 | EPIC PHARMA LLC | ANDA 075590 | — | Feb 25, 2002 | |
| NABUMETONE | COPLEY PHARM | ANDA 075179 | — | Jun 06, 2000 | |
| NABUMETONE×2 | IMPAX LABS INC | ANDA 075189 | — | May 26, 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.
Nabumetone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
