TobraDex
TobraDex
Approved
Approval ID
330ac1f7-d583-454d-96bf-37c5af31a369
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-203
Application NumberNDA050592
Product Classification
M
Marketing Category
C73594
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 18, 2007
FDA Product Classification
INGREDIENTS (10)
tobramycinActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
dexamethasoneActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
sodium sulfateInactive
Code: 0YPR65R21J
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT