FDA Orange Book · active-ingredient family
Etodolac
Etodolac: 2 brands, 39 generics; first approved Jan 31, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 39 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
39
Listed patents
0
Presentations
83
Brand (NDA) products
Originator applications
- LODINE XLRLDWYETH PHARMS INCNDA 02058419963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — 600MG TABLET, EXTENDED RELEASE ORAL Discontinued — 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LODINERLDWYETH PHARMS INCNDA 01892219914 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (39)
Abbreviated applications
- ETODOLACIPCA LABS LTDANDA 20544820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - ETODOLACIPCA LABS LTDANDA 20472920242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACPHARMACOANDA 21070420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACUNICHEMANDA 21226320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Rx AB 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 600MG TABLET, EXTENDED RELEASE ORAL Rx AB - ETODOLACADAPTISANDA 20988820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACAMNEAL PHARMS COANDA 20883420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACZYDUS PHARMSANDA 09113420143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Rx AB 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 600MG TABLET, EXTENDED RELEASE ORAL Rx AB - ETODOLACTAROANDA 07617420033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Rx AB 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 600MG TABLET, EXTENDED RELEASE ORAL Rx AB - ETODOLACAPOTEXANDA 07600420022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACANI PHARMSANDA 07594320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 600MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ETODOLACWATSON LABS FLORIDAANDA 07582920012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ETODOLACTEVAANDA 07566520013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL Rx AB 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 400MG TABLET, EXTENDED RELEASE ORAL Rx AB - ETODOLACACTAVIS ELIZABETHANDA 0756962000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ETODOLACAPOTEXANDA 07541920002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - ETODOLACANI PHARMSANDA 07512619992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - ETODOLACTEVAANDA 07484719992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACRANBAXY LABS LTDANDA 07522619982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACMYLANANDA 07507119982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACMYLANANDA 07501219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACTAROANDA 07507819982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - ETODOLACWATSON LABSANDA 0750691998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - ETODOLACTARO PHARM INDSANDA 07507419982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACNATCO PHARMAANDA 07510419982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACBIOPHARMANDA 0749291998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - ETODOLACANI PHARMSANDA 07484419972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACTEVAANDA 07500919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACBIOPHARMANDA 0749271997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - ETODOLACSANDOZANDA 07494219972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACANI PHARMSANDA 07484019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACCHARTWELL MOLECULESANDA 07484219972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACSENORES PHARMSANDA 0748391997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - ETODOLACANI PHARMSANDA 07489919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACCHARTWELL MOLECULESANDA 0748411997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — - ETODOLACNATCO PHARMAANDA 07493219972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - ETODOLACWATSON LABSANDA 07489219972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACPANGEAANDA 07490319972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ETODOLACIVAX SUB TEVA PHARMSANDA 07488319972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACOXFORD PHARMSANDA 07481919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - ETODOLACSHREE HARI INTLANDA 0748461997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
36 yr 1 mo ago
Most recent approval
2 yr 1 mo ago
Approvals span 1991–2024 across 41 FDA applications.
Brand (NDA) 25%
Generic (ANDA) 3995%
Etodolac: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
