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FDA NDA · NDA206185

XELPROS

latanoprost

Sponsor: SUN PHARM

APPLICATION
NDA206185
TYPE
NDA
ORIGINAL APPROVAL
2018-09-12
LATEST ACTION
2024-10-09
ROUTE
OPHTHALMIC, TOPICAL
DOSAGE FORM
EMULSION
MARKETING STATUS
Discontinued

Products

XELPROS · ReferenceDiscontinued
LATANOPROST 0.005% · EMULSION · OPHTHALMIC

Approval history

2024-10-09Labeling · Supplement 19 · standard — Label ↗AP
2020-12-21Labeling · Supplement 9 · standard — Letter ↗AP
2018-09-12Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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