Tobramycin
TobramycinOphthalmic Solution USP, 0.3% (Sterile)
Approved
Approval ID
86c5ae32-18ab-47b2-91f8-cb0dc289e873
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-108
Application NumberANDA064052
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 13, 2012
FDA Product Classification
INGREDIENTS (9)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT