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FDA Approval

Vitamin Deficiency System

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

FDA Approval Summary

Company
IT3 Medical LLC
DUNS: 079971231
Effective Date
February 25, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin B12(1000 ug in 1 mL)

Products1

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

Vitamin Deficiency System

Product Details

NDC Product Code
70529-293
Application Number
ANDA080515
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, SUBCUTANEOUS
Effective Date
August 17, 2018
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: P6YC3EG204Class: ACTIBQuantity: 1000 ug in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
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