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FDA NDA · NDA050804

LOTEPREDNOL ETABONATE AND TOBRAMYCIN

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA050804
TYPE
NDA
ORIGINAL APPROVAL
2004-12-14
LATEST ACTION
2021-10-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

ZYLET · ReferencePrescription
LOTEPREDNOL ETABONATE 0.5%, TOBRAMYCIN 0.3% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2021-10-25Labeling · Supplement 26 · standard — Letter ↗AP
2013-10-09Manufacturing (CMC) · Supplement 20 · standardAP
2013-02-06Efficacy · Supplement 18 · standard — Pediatric Written Request ↗AP
2012-10-02Labeling · Supplement 17 · standard — Label ↗AP
2010-06-03Labeling · Supplement 15 · unknown — Label ↗AP
2006-08-07Manufacturing (CMC) · Supplement 3AP
2004-12-14Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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