IYUZEH
These highlights do not include all the information needed to use IYUZEH safely and effectively. See full prescribing information for IYUZEH. IYUZEH (latanoprost ophthalmic solution) 0.005%, for topical ophthalmic use Initial U.S. Approval: 1996
Approved
Approval ID
192fc081-cc38-4e83-b779-9592e060b915
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
Thea Pharma Inc.
DUNS: 117787029
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Latanoprost Ophthalmic Solution 0.005%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82584-003
Application NumberNDA216472
Product Classification
M
Marketing Category
C73594
G
Generic Name
Latanoprost Ophthalmic Solution 0.005%
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (8)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT