Orange Book product · Brand (NDA)
LODINE
ETODOLAC
At a glance
Jan 31, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 1991
35 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ETODOLAC
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018922
Product number
002
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.
- 1996LODINE XLBrand (NDA)
NDA 020584 · 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.
