FDA Orange Book · active-ingredient family
Edetate calcium disodium
Edetate calcium disodium is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CALCIUM DISODIUM VERSENATE · NDA 008922
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCIUM DISODIUM VERSENATERLD×2 | BAUSCH | NDA 008922 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EDETATE CALCIUM DISODIUM | CASPER PHARMA LLC | ANDA 216435 | — | May 03, 2023 |
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.
Edetate calcium disodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
