Gentamicin sulfate
GENTAMICIN SULFATE OINTMENT USP, 0.1%
Approved
Approval ID
f986fa2a-e667-452f-be4c-bad8588af525
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 5, 2014
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code0168-0078
Application NumberANDA062533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 17, 2010
FDA Product Classification
INGREDIENTS (4)
GENTAMICINActive
Quantity: 1 mg in 1 g
Code: T6Z9V48IKG
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT