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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 Initial U.S. Approval: 2012

Approved
Approval ID

fcaab8b3-3791-49ba-909e-a09651a30b33

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 9, 2022

Manufacturers
FDA

Micro Labs Limited

DUNS: 862174955

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

tafluprost opthalmic

PRODUCT DETAILS

NDC Product Code42571-264
Application NumberANDA209051
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateJune 9, 2022
Generic Nametafluprost opthalmic

INGREDIENTS (8)

EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TAFLUPROSTActive
Quantity: 0.0045 mg in 0.3 mL
Code: 1O6WQ6T7G3
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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tafluprost - FDA Drug Approval Details