ANDA 218745, held by Apotex Corp. Cupric Sulfate.
As of Nov 15, 2026, ANDA 218745 (Cupric Sulfate), held by Apotex Corp, was first approved by FDA on Aug 19, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cupric SulfateEQ 0.4MG COPPER/ML ยท injectable;injection | Cupric Sulfate | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
