FDA Orange Book · active-ingredient family
Sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, monohydrate
Sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, monohydrate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SODIUM PHOSPHATES IN PLASTIC CONTAINER · NDA 018892
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM PHOSPHATES IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 018892 | AP | May 10, 1983 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM PHOSPHATES×3 | CAPLIN | ANDA 220683 | AP | Feb 23, 2026 | |
| SODIUM PHOSPHATES×3 | AM REGENT | ANDA 218314 | AP | Jun 21, 2024 | |
| SODIUM PHOSPHATES×3 | FRESENIUS KABI USA | ANDA 209997 | AP | Mar 30, 2022 |
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.
Sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, monohydrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
