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Cyanocobalamin

Cyanocobalamin Injection, USP

Approved
Approval ID

e559c6c8-2973-77fb-e053-2995a90af43d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers
FDA

SOLA Pharmaceuticals

DUNS: 080121345

Products 1

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

Cyanocobalamin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70512-840
Application NumberANDA215417
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateNovember 16, 2023
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Cyanocobalamin - FDA Drug Approval Details