FDA Orange Book · active-ingredient family
Etomidate
Etomidate is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AMIDATE · NDA 018227
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMIDATERLD | HOSPIRA | NDA 018227 | AP | Sep 07, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ETOMIDATE | CAPLIN | ANDA 215028 | AP | Dec 18, 2020 | |
| ETOMIDATE | GLAND | ANDA 209058 | AP | Apr 18, 2017 | |
| ETOMIDATE | EUGIA PHARMA | ANDA 206126 | AP | Feb 24, 2017 | |
| ETOMIDATE | MYLAN LABS LTD | ANDA 201044 | AP | Feb 07, 2017 | |
| ETOMIDATE | HIKMA | ANDA 202354 | AP | Feb 25, 2016 | |
| ETOMIDATE | AVET LIFESCIENCES | ANDA 204618 | — | Aug 13, 2014 | |
| ETOMIDATE | ZYDUS PHARMS | ANDA 202360 | AP | Jul 18, 2014 | |
| ETOMIDATE | PH HEALTH | ANDA 091297 | — | Jun 20, 2012 | |
| ETOMIDATE | LUITPOLD | ANDA 078867 | — | Dec 22, 2009 | |
| ETOMIDATE | RISING | ANDA 078289 | — | Jan 02, 2009 | |
| ETOMIDATE | HIKMA | ANDA 074593 | AP | Nov 04, 1996 |
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.
Etomidate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
