FDA Orange Book · active-ingredient family
Calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate
Calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BSS · NDA 020742
3
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BSSRLD | ALCON | NDA 020742 | AT | Dec 10, 1997 | |
| ISOLYTE E IN PLASTIC CONTAINER | B BRAUN | NDA 019718 | — | Sep 29, 1989 | |
| ISOLYTE E IN PLASTIC CONTAINER | B BRAUN | NDA 018899 | — | Oct 31, 1983 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BALANCED SALT | B BRAUN | ANDA 091387 | AT | Feb 03, 2010 | |
| BALANCED SALT | EPIC PHARMA LLC | ANDA 075503 | — | Sep 27, 2006 |
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.
Calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
