ZIOPTAN
These highlights do not include all the information needed to use ZIOPTAN (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN . ZIOPTAN (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012
Approved
Approval ID
db529b54-2ac7-4020-9791-7333bbe6c90f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
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.
Tafluprost
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82584-609
Application NumberNDA202514
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tafluprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (8)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TAFLUPROSTActive
Quantity: 0.015 mg in 1 mL
Code: 1O6WQ6T7G3
Classification: ACTIB