TOBRAMYCIN AND DEXAMETHASONE
Sterile
Approved
Approval ID
e236d98c-128e-b2f7-e053-2a95a90a7422
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 24, 2022
Manufacturers
FDA
NuCare Pharmaceuticasl,Inc.
DUNS: 010632300
Products 1
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 Code68071-2772
Application NumberANDA212715
Product Classification
M
Marketing Category
C73584
G
Generic Name
tobramycin and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 24, 2022
FDA Product Classification
INGREDIENTS (11)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT