FDA NDA · NDA202514

TAFLUPROST OPHTHALMIC

tafluprost

Sponsor: THEA PHARMA

APPLICATION

NDA202514

TYPE

NDA

ORIGINAL APPROVAL

2012-02-10

LATEST ACTION

2026-02-25

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

ZIOPTAN · ReferencePrescription

TAFLUPROST 0.0015% · SOLUTION/DROPS · OPHTHALMIC

2026-02-25Labeling · Supplement 8 · standard — Letter ↗AP

2015-09-04Labeling · Supplement 4 · standard — Letter ↗AP

2015-09-04Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP

2013-08-28Manufacturing (CMC) · Supplement 2 · standardAP

2013-02-22Labeling · Supplement 1 · standard — Letter ↗AP

2012-02-10Type 1 - New Molecular Entity · Original · standard — Label ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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