Orange Book product · Brand (NDA)
RELAFEN
NABUMETONE
At a glance
Dec 24, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
NABUMETONE
Strength
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019583
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.
- 2025NABUMETONEGeneric (ANDA)
ANDA 219118 · NOVITIUM PHARMA
- 2019NABUMETONEGeneric (ANDA)
ANDA 203166 · LGM PHARMA
- 2011NABUMETONEGeneric (ANDA)
ANDA 090427 · MPP PHARMA
- 2011NABUMETONEGeneric (ANDA)
ANDA 091083 · WATSON LABS
- 2011NABUMETONEGeneric (ANDA)
ANDA 090445 · ANNORA PHARMA
- 2010NABUMETONEGeneric (ANDA)
ANDA 090516 · AUROBINDO PHARMA USA
- 2009NABUMETONEGeneric (ANDA)
ANDA 079093 · OXFORD PHARMS
- 2008NABUMETONEGeneric (ANDA)
ANDA 078420 · SCIEGEN PHARMS
- 2008NABUMETONEGeneric (ANDA)
ANDA 078671 · INVAGEN PHARMS
- 2003NABUMETONEGeneric (ANDA)
ANDA 076009 · CHARTWELL MOLECULES
- 2002NABUMETONEGeneric (ANDA)
ANDA 075280 · CHARTWELL RX
- 2002NABUMETONEGeneric (ANDA)
ANDA 075590 · EPIC PHARMA LLC
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.
