Tobramycin and Dexamethasone
Tobramycin and Dexamethasone Ophthalmic Suspension Sterile
Approved
Approval ID
8f7f1b78-8ac3-4ba5-b0ec-ca87a433ad39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tobramycin and Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-984
Application NumberNDA050592
Product Classification
M
Marketing Category
C73605
G
Generic Name
Tobramycin and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 14, 2011
FDA Product Classification
INGREDIENTS (11)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT