TheraRadar
Data updated: Jul 17, 2026

CYANOCOBALAMIN · WEST-WARD PHARMS INT

Generic · see VIBISONE
Other Approved 1949-09-15

CYANOCOBALAMIN is FDA-approved to treat 1 condition (same as VIBISONE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
24
Indications
--
Phase 3 Trials
76
Years on Market

Details

Status
Prescription
First Approved
1949-09-15
Routes
INJECTION, ORAL, NASAL
Dosage Forms
INJECTABLE, TABLET, SPRAY, METERED

Companies

WEST-WARD PHARMS INT Sanofi LYPHOMED SOMERSET THERAPS LLC XIROMED Hikma SOLA PHARMS Dr. Reddy's WATSON LABS INC Lupin SAGENT PHARMS INC LUITPOLD AM REGENT SOLOPAK WARNER CHILCOTT MANKIND PHARMA Novartis EUGIA PHARMA Viatris Pfizer PHARMOBEDIENT MEITHEAL ABRAXIS PHARM Fresenius Kabi EPIC PHARMA LLC VITRUVIAS THERAP DELL LABS PADAGIS ISRAEL GLAND ZYDUS PHARMS ASPIRO
Active Ingredient: CYANOCOBALAMIN

CYANOCOBALAMIN Approval History

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Original
New Indication
New Form
Label Update
130 FDA actions from 1949 to 2026 · 1 indication expansions
Jul 2026 ORIGINAL
Update
Feb 2025 SUPPL
Mfg · Manufacturing (CMC)
Jan 2025 SUPPL
Label · Labeling

What CYANOCOBALAMIN Treats

1 indications

CYANOCOBALAMIN is approved for 1 conditions since its original approval in 1949. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Nutritional Deficiency

Same approved indications as VIBISONE (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT04387201 results posted HSC-MS-19-0787 R21DK122234 Ph 4 completed GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
NCT05005897 RART 9305-150426 U1111-1267-0112 Ph 2, Ph 3 recruiting Early Infant Micronutrition and Development
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

CYANOCOBALAMIN is FDA-approved to treat 1 condition — same approved indications as VIBISONE.

Looking for the branded version?

VIBISONE

Full clinical data, patents, trials, and competitive landscape for cyanocobalamin.

See VIBISONE

Data Sources

FDA Approval: ANDA080515 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.