Tobramycin
Tobramycin OphthalmicSolution USP, 0.3%
Approved
Approval ID
f54c1882-ca08-47f3-9c02-93551f39905e
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 Code21695-204
Application NumberANDA063176
Product Classification
M
Marketing Category
C73584
G
Generic Name
tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 13, 2006
FDA Product Classification
INGREDIENTS (8)
tobramycinActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
sodium sulfateInactive
Code: 0YPR65R21J
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
boric acidInactive
Code: R57ZHV85D4
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT