TOBRAMYCIN AND DEXAMETHASONE
Sterile
Approved
Approval ID
3c63c481-ce57-41ca-993f-5a5b665fa1e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9570
Application NumberANDA212715
Product Classification
M
Marketing Category
C73584
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (11)
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT