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FDA NDA · NDA210565

INVELTYS

loteprednol etabonate

Sponsor: ALCON LABS INC

APPLICATION
NDA210565
TYPE
NDA
ORIGINAL APPROVAL
2018-08-22
LATEST ACTION
2020-04-24
ROUTE
TOPICAL, OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

INVELTYS · ReferencePrescription
LOTEPREDNOL ETABONATE 1% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2020-04-24Labeling · Supplement 3 · standard — Label ↗AP
2018-08-22Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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