Gentamicin Sulfate
Gentamicin Sulfate Ophthalmic Solution USP, 0.3%
Approved
Approval ID
32c24dd7-11d4-420a-afee-a6e37baa4d0f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2017
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code53217-229
Application NumberANDA064163
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 20, 2017
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 3 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT