FDA Orange Book · active-ingredient family
Calcium chloride
Calcium chloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER · NDA 021117
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCIUM CHLORIDE 10% IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 021117 | AP | Jan 28, 2000 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCIUM CHLORIDE 10% | SQUARE PHARMS PLC | ANDA 217463 | AP | Sep 29, 2025 | |
| CALCIUM CHLORIDE 10% | SOMERSET | ANDA 218133 | AP | Dec 17, 2024 | |
| CALCIUM CHLORIDE 10% | EXTROVIS | ANDA 219342 | AP | Nov 27, 2024 | |
| CALCIUM CHLORIDE 10% | AMNEAL | ANDA 217524 | AP | Jul 08, 2024 | |
| CALCIUM CHLORIDE 10% | MEDEFIL INC | ANDA 211553 | AP | May 01, 2019 | |
| CALCIUM CHLORIDE 10% | INTL MEDICATION SYS | ANDA 203477 | AP | May 09, 2018 | |
| CALCIUM CHLORIDE 10% | AM REGENT | ANDA 209088 | AP | Jul 27, 2017 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
