FDA Orange Book · active-ingredient family
Cupric sulfate
Cupric sulfate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CUPRIC SULFATE · NDA 019350
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CUPRIC SULFATERLD | ABRAXIS PHARM | NDA 019350 | — | May 05, 1987 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CUPRIC SULFATE | APOTEX CORP | ANDA 218745 | — | Aug 19, 2024 | |
| CUPRIC SULFATE | AM REGENT | ANDA 216324 | — | Dec 16, 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.
Cupric sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
