NDA 209377, held by Am Regent. Zinc Sulfate.
As of Nov 13, 2026, NDA 209377 (Zinc Sulfate), held by Am Regent, was first approved by FDA on Jul 18, 2019, with 1 approved supplement and 0 published complete response letters.
Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Zinc SulfateEQ 30MG BASE/10ML (EQ 3MG BASE/ML) · solution;intravenous | Zinc Sulfate | RxReference drug |
| Zinc SulfateEQ 25MG BASE/5ML (EQ 5MG BASE/ML) · solution;intravenous | Zinc Sulfate | RxReference drug |
| Zinc SulfateEQ 10MG BASE/10ML (EQ 1MG BASE/ML) · solution;intravenous | Zinc Sulfate | RxReference drug |
| Oct 28, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Jul 18, 2019 | Original applicationNew formulation or manufacturer · Standard review | 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
