Tobramycin
Tobramycin Ophthalmic Solution, USP 0.3% Rx Only
Approved
Approval ID
3a8dc8f9-3c93-4362-892e-72f6df9527f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3569
Application NumberANDA062535
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 9, 2012
FDA Product Classification
INGREDIENTS (9)
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TOBRAMYCINActive
Quantity: 3.0 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT