FDA Orange Book · active-ingredient family
Ethacrynate sodium
Ethacrynate sodium: 1 brand, 4 generics; first approved Jul 29, 2015; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- BAUSCHNDA 016093—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (4)
Abbreviated applications
- ETHACRYNATE SODIUMSTERIMAXANDA 2086632020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - ETHACRYNATE SODIUMZYDUS PHARMSANDA 2077582017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - ETHACRYNATE SODIUMMYLAN INSTITUTIONALANDA 2046342016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ETHACRYNATE SODIUMPH HEALTHANDA 2054732015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
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
11 yr 2 mo ago
Most recent approval
6 yr 3 mo ago
Approvals span 2015–2020 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Ethacrynate sodium: 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.
