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FDA Approval

Amikacin Sulfate Injection, 500 mg/2ml

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

FDA Approval Summary

Company
Effective Date
January 3, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Amikacin(500 mg in 1 1)

Products1

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

Amikacin Sulfate Injection, 500 mg/2ml

Product Details

NDC Product Code
71309-996
Route of Administration
INTRAMUSCULAR
Effective Date
January 3, 2021
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
AmikacinActive
Code: N6M33094FDClass: ACTIMQuantity: 500 mg in 1 1
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
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