TOBRAMYCIN
TOBRAMYCIN OPTH SOLN
Approved
Approval ID
87349ae8-4709-7f5a-e053-2a91aa0ae3d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
DirectRX
DUNS: 079254320
Products 2
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 Code61919-642
Application NumberANDA207444
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOBRAMYCIN
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (9)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
SODIUM SULFATE ANHYDROUSInactive
Code: 36KCS0R750
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TOBRAMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-598
Application NumberANDA062535
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOBRAMYCIN
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (9)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT