FDA Orange Book · active-ingredient family
Ethacrynic acid
Ethacrynic acid is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EDECRIN · NDA 016092
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EDECRINRLD×2 | BAUSCH | NDA 016092 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ETHACRYNIC ACID | CHARTWELL RX | ANDA 213240 | AB | Oct 19, 2020 | |
| ETHACRYNIC ACID | UPSHER SMITH LABS | ANDA 212417 | AB | Feb 19, 2020 | |
| ETHACRYNIC ACID | LUPIN | ANDA 211719 | AB | Sep 06, 2019 | |
| ETHACRYNIC ACID | SCIEGEN PHARMS | ANDA 211232 | AB | Aug 27, 2019 | |
| ETHACRYNIC ACID | AGNITIO | ANDA 211809 | AB | Jul 12, 2019 | |
| ETHACRYNIC ACID | ALVOGEN | ANDA 205709 | — | Jul 24, 2018 | |
| ETHACRYNIC ACID | AMNEAL PHARMS CO | ANDA 208805 | AB | May 08, 2018 | |
| ETHACRYNIC ACID | PH HEALTH | ANDA 208501 | — | Jul 21, 2017 | |
| ETHACRYNIC ACID | HIKMA | ANDA 207262 | — | Feb 23, 2017 | |
| ETHACRYNIC ACID | ADAPTIS | ANDA 205609 | AB | Jun 30, 2016 |
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.
Ethacrynic acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
