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Cyanokit

These highlights do not include all the information needed to use CYANOKIT safely and effectively. See full prescribing information for CYANOKIT. CYANOKIT (hydroxocobalamin for injection) for intravenous infusion Initial U.S. Approval: 1975

Approved
Approval ID

4368656c-6c2b-474c-6144-4f532d424646

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 15, 2021

Manufacturers
FDA

Meridian Medical Technologies, Inc.

DUNS: 167671341

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydroxocobalamin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11704-370
Application NumberNDA022041
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydroxocobalamin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 15, 2021
FDA Product Classification

INGREDIENTS (2)

HydroxocobalaminActive
Quantity: 5 g in 250 mL
Code: Q40X8H422O
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT

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Cyanokit - FDA Drug Approval Details