FDA Orange Book · active-ingredient family
Etomidate
Etomidate: 1 brand, 11 generics; first approved Sep 07, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
11
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- HOSPIRANDA 0182271982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (11)
Abbreviated applications
- ETOMIDATECAPLINANDA 2150282020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ETOMIDATEGLANDANDA 2090582017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ETOMIDATEEUGIA PHARMAANDA 2061262017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ETOMIDATEMYLAN LABS LTDANDA 2010442017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ETOMIDATEHIKMAANDA 2023542016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ETOMIDATEAVET LIFESCIENCESANDA 2046182014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - ETOMIDATEZYDUS PHARMSANDA 2023602014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - ETOMIDATEPH HEALTHANDA 0912972012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - ETOMIDATELUITPOLDANDA 0788672009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - ETOMIDATERISINGANDA 0782892009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - ETOMIDATEHIKMAANDA 0745931996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML 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
44 yr 7 mo ago
Most recent approval
5 yr 9 mo ago
Approvals span 1982–2020 across 12 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1192%
Etomidate: 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.
