FDA Orange Book · active-ingredient family
Etodolac
Etodolac is approved as 2 brand and 39 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LODINE XL · NDA 020584
2
Brand (NDA)
39
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LODINE XLRLD×3 | WYETH PHARMS INC | NDA 020584 | — | Oct 25, 1996 | |
| LODINERLD×4 | WYETH PHARMS INC | NDA 018922 | — | Jan 31, 1991 |
Generic (ANDA) products (39)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ETODOLAC×2 | IPCA LABS LTD | ANDA 205448 | AB | Aug 01, 2024 | |
| ETODOLAC×2 | IPCA LABS LTD | ANDA 204729 | AB | May 01, 2024 | |
| ETODOLAC×2 | PHARMACO | ANDA 210704 | AB | Dec 16, 2020 | |
| ETODOLAC×3 | UNICHEM | ANDA 212263 | AB | Nov 24, 2020 | |
| ETODOLAC×2 | ADAPTIS | ANDA 209888 | AB | Nov 30, 2018 | |
| ETODOLAC×2 | AMNEAL PHARMS CO | ANDA 208834 | AB | Jun 07, 2018 | |
| ETODOLAC×3 | ZYDUS PHARMS | ANDA 091134 | AB | Jan 23, 2014 | |
| ETODOLAC×3 | TARO | ANDA 076174 | AB | Mar 13, 2003 | |
| ETODOLAC×2 | APOTEX | ANDA 076004 | AB | Dec 03, 2002 | |
| ETODOLAC×3 | ANI PHARMS | ANDA 075943 | — | Jul 26, 2002 | |
| ETODOLAC×2 | WATSON LABS FLORIDA | ANDA 075829 | — | Nov 30, 2001 | |
| ETODOLAC×3 | TEVA | ANDA 075665 | AB | Feb 05, 2001 | |
| ETODOLAC | ACTAVIS ELIZABETH | ANDA 075696 | — | Jul 31, 2000 | |
| ETODOLAC×2 | APOTEX | ANDA 075419 | AB | Jul 28, 2000 | |
| ETODOLAC×2 | ANI PHARMS | ANDA 075126 | AB | Sep 16, 1999 | |
| ETODOLAC×2 | TEVA | ANDA 074847 | — | Apr 23, 1999 | |
| ETODOLAC×2 | RANBAXY LABS LTD | ANDA 075226 | — | Nov 24, 1998 | |
| ETODOLAC×2 | MYLAN | ANDA 075071 | — | Sep 30, 1998 | |
| ETODOLAC×2 | MYLAN | ANDA 075012 | — | Sep 30, 1998 | |
| ETODOLAC×2 | TARO | ANDA 075078 | AB | Apr 30, 1998 | |
| ETODOLAC | WATSON LABS | ANDA 075069 | — | Apr 16, 1998 | |
| ETODOLAC×2 | TARO PHARM INDS | ANDA 075074 | AB | Mar 11, 1998 | |
| ETODOLAC×2 | NATCO PHARMA | ANDA 075104 | — | Feb 06, 1998 | |
| ETODOLAC | BIOPHARM | ANDA 074929 | — | Jan 30, 1998 | |
| ETODOLAC×2 | ANI PHARMS | ANDA 074844 | — | Dec 23, 1997 | |
| ETODOLAC×2 | TEVA | ANDA 075009 | — | Nov 26, 1997 | |
| ETODOLAC | BIOPHARM | ANDA 074927 | — | Oct 30, 1997 | |
| ETODOLAC×2 | SANDOZ | ANDA 074942 | — | Sep 30, 1997 | |
| ETODOLAC×2 | ANI PHARMS | ANDA 074840 | — | Aug 29, 1997 | |
| ETODOLAC×2 | CHARTWELL MOLECULES | ANDA 074842 | — | Jul 17, 1997 | |
| ETODOLAC | SENORES PHARMS | ANDA 074839 | — | Jul 11, 1997 | |
| ETODOLAC×2 | ANI PHARMS | ANDA 074899 | — | Jul 08, 1997 | |
| ETODOLAC | CHARTWELL MOLECULES | ANDA 074841 | — | Jun 27, 1997 | |
| ETODOLAC×2 | NATCO PHARMA | ANDA 074932 | — | May 16, 1997 | |
| ETODOLAC×2 | WATSON LABS | ANDA 074892 | — | Apr 16, 1997 | |
| ETODOLAC×2 | PANGEA | ANDA 074903 | AB | Apr 11, 1997 | |
| ETODOLAC×2 | IVAX SUB TEVA PHARMS | ANDA 074883 | — | Feb 28, 1997 | |
| ETODOLAC×2 | OXFORD PHARMS | ANDA 074819 | — | Feb 28, 1997 | |
| ETODOLAC | SHREE HARI INTL | ANDA 074846 | — | Feb 28, 1997 |
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.
Etodolac — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
