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Amikacin Sulfate Injection, 500 mg/2ml

Amikacin Sulfate Injection, 500 mg / 2ml

Approved
Approval ID

882c39a9-2198-9063-e053-2995a90af7ad

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 5, 2019

Manufacturers
FDA

Prodigy Innovation, LLC.

DUNS: 080058064

Products 1

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70297-996
Product Classification
G
Generic Name
Amikacin Sulfate Injection, 500 mg/2ml
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMay 5, 2019
FDA Product Classification

INGREDIENTS (4)

SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
AMIKACIN SULFATEActive
Quantity: 500 mg in 1 1
Code: N6M33094FD
Classification: ACTIM

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Amikacin Sulfate Injection, 500 mg/2ml - FDA Drug Approval Details