Gentamicin Sulfate
Approved
Approval ID
78d87bc5-be86-4429-8ca3-e0a883108f9b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6126
Application NumberANDA062533
Product Classification
M
Marketing Category
C73584
G
Generic Name
gentamicin sulfate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 10, 2010
FDA Product Classification
INGREDIENTS (4)
GENTAMICIN SULFATEActive
Quantity: 1 mg in 1 g
Code: 8X7386QRLV
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT