GENTAMICIN SULFATE
GENTAMICIN SULFATEOphthalmic Solution, USP 0.3%
Approved
Approval ID
d7a27e38-0553-4d4b-8438-fed235e9b989
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-187
Application NumberANDA062452
Product Classification
M
Marketing Category
C73584
G
Generic Name
gentamicin sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 18, 2006
FDA Product Classification
INGREDIENTS (9)
gentamicin sulfateActive
Quantity: 3.0 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT