Orange Book product · Brand (NDA)
LODINE XL
ETODOLAC
At a glance
Oct 25, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 1996
30 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ETODOLAC
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020584
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1991LODINEBrand (NDA)
NDA 018922 · WYETH PHARMS INC
- 2024ETODOLACGeneric (ANDA)
ANDA 205448 · IPCA LABS LTD
- 2024ETODOLACGeneric (ANDA)
ANDA 204729 · IPCA LABS LTD
- 2020ETODOLACGeneric (ANDA)
ANDA 210704 · PHARMACO
- 2020ETODOLACGeneric (ANDA)
ANDA 212263 · UNICHEM
- 2018ETODOLACGeneric (ANDA)
ANDA 209888 · ADAPTIS
- 2018ETODOLACGeneric (ANDA)
ANDA 208834 · AMNEAL PHARMS CO
- 2014ETODOLACGeneric (ANDA)
ANDA 091134 · ZYDUS PHARMS
- 2003ETODOLACGeneric (ANDA)
ANDA 076174 · TARO
- 2002ETODOLACGeneric (ANDA)
ANDA 076004 · APOTEX
- 2002ETODOLACGeneric (ANDA)
ANDA 075943 · ANI PHARMS
- 2001ETODOLACGeneric (ANDA)
ANDA 075829 · WATSON LABS FLORIDA
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.
