tobramycin and dexamethasone
Tobramycin and Dexamethasone Ophthalmic Suspension, USP Sterile
Approved
Approval ID
2a7eea7d-b82d-481a-a83d-96fe21d21cd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tobramycin and dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1374
Application NumberANDA212991
Product Classification
M
Marketing Category
C73584
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (11)
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
tobramycin and dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1375
Application NumberANDA212991
Product Classification
M
Marketing Category
C73584
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (11)
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
tobramycin and dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1373
Application NumberANDA212991
Product Classification
M
Marketing Category
C73584
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 30, 2023
FDA Product Classification
INGREDIENTS (11)
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT