TobraDex
TobraDex
Approved
Approval ID
fe08bcd5-4d14-4c2d-940c-b7968f9a89f0
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 Code21695-628
Application NumberNDA050616
Product Classification
M
Marketing Category
C73594
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 20, 2006
FDA Product Classification
INGREDIENTS (5)
tobramycinActive
Quantity: 3 mg in 1 g
Code: VZ8RRZ51VK
Classification: ACTIB
chlorobutanolInactive
Quantity: 5 mg in 1 g
Code: HM4YQM8WRC
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
dexamethasoneActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB