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GENTAMICIN SULFATE

GENTAMICIN Sulfate Solution

Approved
Approval ID

0a7a06ce-5b6a-45c7-a18e-cb4d6598146d

Product Type

PRESCRIPTION ANIMAL DRUG LABEL

Effective Date

Apr 29, 2025

Manufacturers
FDA

Covetrus North America

DUNS: 603750329

Products 1

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

GENTAMICIN SULFATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11695-4153
Application NumberANADA200395
Product Classification
M
Marketing Category
C73583
G
Generic Name
GENTAMICIN SULFATE
Product Specifications
Route of AdministrationINTRAUTERINE
Effective DateApril 29, 2025
FDA Product Classification

INGREDIENTS (6)

SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3G
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 100 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT

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GENTAMICIN SULFATE - FDA Drug Approval Details