Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
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
50090-1135Application Number
NDA050592Marketing Category
NDA authorized generic (C73605)Route of Administration
OPHTHALMICEffective Date
May 29, 2018TobramycinActive
Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL
DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
TYLOXAPOLInactive
Code: Y27PUL9H56Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21JClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16Class: IACT