Data updated: Mar 10, 2026
CYANOCOBALAMIN
CYANOCOBALAMIN
Approved 1949-12-06
23
Indications
--
Phase 3 Trials
76
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1949-12-06
- Routes
- INJECTION, NASAL, ORAL
- Dosage Forms
- INJECTABLE, SPRAY, METERED, TABLET
Companies
Pfizer PADAGIS ISRAEL Fresenius Kabi SOLOPAK EPIC PHARMA LLC SOMERSET THERAPS LLC Novartis AM REGENT LYPHOMED PHARMOBEDIENT Dr. Reddy's LUITPOLD VITRUVIAS THERAP SAGENT PHARMS INC MANKIND PHARMA Sanofi WARNER CHILCOTT WEST-WARD PHARMS INT GLAND ABRAXIS PHARM Lupin EUGIA PHARMA Hikma MEITHEAL Viatris DELL LABS WATSON LABS ZYDUS PHARMS XIROMED SOLA PHARMS
Active Ingredient: CYANOCOBALAMIN
Website: ↗
CYANOCOBALAMIN Approval History
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What CYANOCOBALAMIN Treats
23 FDA approvalsOriginally approved for its first indication in 1949 . Covers 23 distinct patient populations.
- Other (23)
Other
(23 approvals)- • Approved indication (Dec 1949)
- • Approved indication (Oct 1971)
- • Approved indication (Apr 1972)
- • Approved indication (Mar 1973)
- • Approved indication (Jun 1973)
- • Approved indication (Jun 1973)
- • Approved indication (Jan 1974)
- • Approved indication (Sep 1979)
- • Approved indication (Jun 1997)
- • Approved indication (Sep 2003)
- • Approved indication (Dec 2015)
- • Approved indication (Jun 2017)
- • Approved indication (Dec 2018)
- • Approved indication (Sep 2020)Letter
- • Approved indication (Sep 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Apr 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Jun 2023)
- • Approved indication (Jul 2024)
- • Approved indication (Nov 2024)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
CYANOCOBALAMIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.