Tobramycin and Dexamethasone
Tobramycin and Dexamethasone Ophthalmic Suspension USP, 0.3%/0.1% (Sterile)
Approved
Approval ID
0e460787-5413-44d3-bd60-69d3d04f97eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6286
Application NumberANDA064134
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 10, 2011
FDA Product Classification
INGREDIENTS (2)
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB