ZINC SULFATE
Details
- Status
- Prescription
- First Approved
- 1987-05-05
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE
Companies
ZINC SULFATE Approval History
What ZINC SULFATE Treats
10 FDA approvalsOriginally approved for its first indication in 1987 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (May 1987)
- • Approved indication (Jul 2019)Label Letter
- • Approved indication (May 2022)Letter
- • Approved indication (Dec 2022)Letter
- • Approved indication (Aug 2023)
- • Approved indication (Jun 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Jul 2024)
- • Approved indication (May 2025) New
- • Approved indication (Jun 2025) New
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZINC SULFATE FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. Zinc Sulfate Injection is a trace element 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.