Tobramycin and Dexamethasone
Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% (Sterile)
Approved
Approval ID
5dda7621-5438-4522-8be0-bc2e8dc418c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
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 Code21695-416
Application NumberNDA050592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tobramycin and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 25, 2009
FDA Product Classification
INGREDIENTS (2)
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB