FDA NDA · NDA020803

LOTEPREDNOL ETABONATE

Sponsor: BAUSCH AND LOMB

APPLICATION

NDA020803

TYPE

NDA

ORIGINAL APPROVAL

1998-03-09

LATEST ACTION

2013-12-16

ROUTE

OPHTHALMIC

DOSAGE FORM

SUSPENSION/DROPS

MARKETING STATUS

Prescription

Products

ALREX · ReferencePrescription

LOTEPREDNOL ETABONATE 0.2% · SUSPENSION/DROPS · OPHTHALMIC

2013-12-16Manufacturing (CMC) · Supplement 26 · standardAP

2013-10-09Manufacturing (CMC) · Supplement 25 · standardAP

2001-08-30Manufacturing (CMC) · Supplement 4 · standardAP

2000-07-18Manufacturing (CMC) · Supplement 3 · standardAP

1999-08-17Manufacturing (CMC) · Supplement 2 · standardAP

1999-05-19Manufacturing (CMC) · Supplement 1 · standardAP

1998-03-09Type 1 - New Molecular Entity · Original · standard — Review ↗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.

Weekly Briefing

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