FDA Orange Book · active-ingredient family
Ethacrynic acid
Ethacrynic acid: 1 brand, 10 generics; first approved Jun 30, 2016; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
10
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- BAUSCHNDA 016092—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- ETHACRYNIC ACIDCHARTWELL RXANDA 2132402020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - ETHACRYNIC ACIDUPSHER SMITH LABSANDA 2124172020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - ETHACRYNIC ACIDLUPINANDA 2117192019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - ETHACRYNIC ACIDSCIEGEN PHARMSANDA 2112322019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - ETHACRYNIC ACIDAGNITIOANDA 2118092019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - ETHACRYNIC ACIDALVOGENANDA 2057092018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - ETHACRYNIC ACIDAMNEAL PHARMS COANDA 2088052018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB - ETHACRYNIC ACIDPH HEALTHANDA 2085012017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - ETHACRYNIC ACIDHIKMAANDA 2072622017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - ETHACRYNIC ACIDADAPTISANDA 2056092016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB
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
10 yr 4 mo ago
Most recent approval
5 yr 11 mo ago
Approvals span 2016–2020 across 11 FDA applications.
Brand (NDA) 19%
Generic (ANDA) 1091%
Ethacrynic acid: 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.
