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FDA Approval

THIAMINE HYDROCHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 14, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Thiamine(100 mg in 1 mL)

Products1

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

THIAMINE HYDROCHLORIDE

Product Details

NDC Product Code
70748-347
Application Number
ANDA215692
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
December 14, 2023
ThiamineActive
Code: M572600E5PClass: ACTIRQuantity: 100 mg in 1 mL
MONOTHIOGLYCEROLInactive
Code: AAO1P0WSXJClass: IACT
CHLOROBUTANOL HEMIHYDRATEInactive
Code: 3X4P6271OXClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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