Tafluprost
These highlights do not include all the information needed to use TAFLUPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for TAFLUPROST OPHTHALMIC SOLUTION. TAFLUPROST ophthalmic solution 0.0015%Initial U.S. Approval: 2012
Approved
Approval ID
bfffa484-4105-45ec-ab1d-124e96639f35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-6184
Application NumberANDA209040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tafluprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (8)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TAFLUPROSTActive
Quantity: 0.0045 mg in 0.3 mL
Code: 1O6WQ6T7G3
Classification: ACTIB
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