Tobramycin
(Sterile)
Approved
Approval ID
a5693ec9-d2f7-4d45-90b0-a113c54840d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
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 Code24208-290
Application NumberANDA064052
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT