Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
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
68071-2418Application Number
ANDA064134Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
May 26, 2021SODIUM SULFATEInactive
Code: 0YPR65R21JClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
TobramycinActive
Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56Class: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT