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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210565


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NDA 210565 describes INVELTYS, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the INVELTYS profile page.

The generic ingredient in INVELTYS is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 210565
Tradename:INVELTYS
Applicant:Alcon Labs Inc
Ingredient:loteprednol etabonate
Patents:12
Pharmacology for NDA: 210565
Medical Subject Heading (MeSH) Categories for 210565
Suppliers and Packaging for NDA: 210565
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565 NDA ALCON LABORATORIES, INC. 71571-121 71571-121-20 2.8 mL in 1 BOTTLE, DROPPER (71571-121-20)
INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565 NDA ALCON LABORATORIES, INC. 71571-121 71571-121-28 1 BOTTLE, DROPPER in 1 CARTON (71571-121-28) / 2.8 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Aug 22, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 3, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
Patent:⤷  Sign UpPatent Expiration:May 3, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 3, 2033Product Flag?YSubstance Flag?Delist Request?

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