Data updated: Jun 28, 2026
HYDROXOCOBALAMIN
Other
Approved 1975-04-18
1
Indication
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Prescription
- First Approved
- 1975-04-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HYDROXOCOBALAMIN Approval History
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
28 FDA actions from 1978 to 2002
Jul 2002 SUPPL
Mfg · Manufacturing (CMC)
Jun 2002 SUPPL
Mfg · Manufacturing (CMC)
Feb 2002 SUPPL
Mfg · Manufacturing (CMC)
Jul 2001 SUPPL
Mfg
May 2001 SUPPL
Mfg
Sep 2000 SUPPL
Mfg
Aug 2000 SUPPL
Mfg
Jun 2000 SUPPL
Mfg
May 2000 SUPPL
Mfg
Nov 1999 SUPPL
Label
Mar 1999 SUPPL
Mfg
Feb 1999 SUPPL
Mfg
Feb 1999 SUPPL
Mfg
Oct 1997 SUPPL
Label
Dec 1996 SUPPL
Mfg
Feb 1992 SUPPL
Label
May 1989 SUPPL
Mfg
Aug 1986 SUPPL
Mfg
Dec 1984 SUPPL
Mfg
Sep 1984 SUPPL
Mfg
Mar 1984 SUPPL
Mfg
Jun 1982 SUPPL
Mfg
Aug 1978 ORIGINAL
Update
What HYDROXOCOBALAMIN Treats
1 FDA approvalsOriginally approved for its first indication in 1978 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 1978)
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
📋
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| NCT03446599 | D17173 | Ph 2 | withdrawn | Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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
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.