HYDROXOCOBALAMIN · WATSON LABS INC
HYDROXOCOBALAMIN is FDA-approved to treat 1 condition (same as CYANOKIT).
Details
- Status
- Prescription
- First Approved
- 1975-04-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HYDROXOCOBALAMIN Approval History
What HYDROXOCOBALAMIN Treats
1 indicationsHYDROXOCOBALAMIN is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cyanide Poisoning
Same approved indications as CYANOKIT (same active ingredient).
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07469189 Shrimp | 2022P003028 | Ph 1 | completed | A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms |
| NCT03783091 B12 results posted | 32950 | Ph 2 | completed | A Trial of Vitamin B12 in Septic Shock |
| NCT04054999 results posted | 18-006247 | Ph 4 | completed | Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients |
| NCT03735316 results posted | 17-011130 | Ph 2 | terminated | Vitamin B12a Vasoplegic Syndrome |
| NCT02270749 | VITAALII | Ph 4 | completed | Vitamin Deficiencies and Suppletion in Morbid Obesity |
| NCT03446599 | D17173 | Ph 2 | withdrawn | Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery |
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.
HYDROXOCOBALAMIN FDA Label Details
Indications & Usage
HYDROXOCOBALAMIN is FDA-approved to treat 1 condition — same approved indications as CYANOKIT.
Looking for the branded version?
CYANOKIT
Full clinical data, patents, trials, and competitive landscape for hydroxocobalamin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.