← FDA DRUG APPROVALS

FDA ANDA · ANDA200925

LATANOPROST

Sponsor: J MOLNER

APPLICATION
ANDA200925
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-22
LATEST ACTION
2021-08-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

LATANOPROSTPrescription
LATANOPROST 0.005% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-08-23Labeling · Supplement 6 · standardAP
2020-06-12Labeling · Supplement 5 · standardAP
2020-06-12Labeling · Supplement 4 · standardAP
2011-03-22OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →