Tobradex ST
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TOBRADEX ST safely and effectively. See full prescribing information for TOBRADEX ST. TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, for topical ophthalmic use Initial U.S. Approval: 1988
Approved
Approval ID
c2d7325e-4f58-5590-e053-2a95a90ace1b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
Eyevance Pharmaceuticals, LLC
DUNS: 080876046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tobramycin / dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71776-035
Application NumberNDA050818
Product Classification
M
Marketing Category
C73594
G
Generic Name
tobramycin / dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (12)
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DEXAMETHASONEActive
Quantity: 0.5 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB