Tobrex
Tobrextobramycin ophthalmicointment 0.3%
Approved
Approval ID
3d4be22b-7a8c-4247-ac35-143611342de1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-458
Application NumberNDA050555
Product Classification
M
Marketing Category
C73594
G
Generic Name
tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 19, 2006
FDA Product Classification
INGREDIENTS (4)
tobramycinActive
Quantity: 3 mg in 1 g
Code: VZ8RRZ51VK
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
chlorobutanolInactive
Quantity: 5 mg in 1 g
Code: HM4YQM8WRC
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT