Gentamicin Sulfate
Gentamicin Sulfate Ointment, USP 0.1% Rx Only For Dermatologic Use Only Not for Ophthalmic Use
Approved
Approval ID
16474069-510b-0754-9d78-9bc0354f6549
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
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 Code0713-0682
Application NumberANDA064054
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 23, 2023
FDA Product Classification
INGREDIENTS (5)
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 1 mg in 1 g
Code: 8X7386QRLV
Classification: ACTIM
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT