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FDA NDA · NDA020583

LOTEPREDNOL ETABONATE

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA020583
TYPE
NDA
ORIGINAL APPROVAL
1998-03-09
LATEST ACTION
2013-12-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

LOTEMAX · ReferencePrescription
LOTEPREDNOL ETABONATE 0.5% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2013-12-16Manufacturing (CMC) · Supplement 28 · standard — Review ↗AP
2013-10-09Manufacturing (CMC) · Supplement 27 · standard — Review ↗AP
2006-07-11Manufacturing (CMC) · Supplement 13AP
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
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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