FDA Orange Book · active-ingredient family
Amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride
Amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PROCALAMINE · NDA 018582
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROCALAMINE | B BRAUN | NDA 018582 | — | May 08, 1982 |
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.
Amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
