ANDA 216324, held by Am Regent. Cupric Sulfate.
As of Nov 15, 2026, ANDA 216324 (Cupric Sulfate), held by Am Regent, was first approved by FDA on Dec 16, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cupric SulfateEQ 0.4MG COPPER/ML · injectable;injection | Cupric Sulfate | Rx |
| Aug 27, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 16, 2022 | Original application | Approved |
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
