Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
079587625
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tobramycin and Dexamethasone
Product Details
NDC Product Code
24208-295Application Number
ANDA064134Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
August 31, 2023TYLOXAPOLInactive
Code: Y27PUL9H56Class: IACT
TobramycinActive
Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16Class: IACT
DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21JClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT