Tobramycin and Dexamethasone
Tobramycin and Dexamethasone Ophthalmic Suspension Sterile
Approved
Approval ID
09315f0b-f15a-30d5-e063-6394a90ac8dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
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
NDC Product Code80425-0366
Application NumberNDA050592
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateNovember 2, 2023
Generic NameTobramycin and Dexamethasone
INGREDIENTS (11)
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
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
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB