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Last Updated: June 12, 2024

Details for New Drug Application (NDA): 208073


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NDA 208073 describes XIIDRA, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from two suppliers. There are sixteen patents protecting this drug. Additional details are available on the XIIDRA profile page.

The generic ingredient in XIIDRA is lifitegrast. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
Summary for 208073
Tradename:XIIDRA
Applicant:Bausch And Lomb Inc
Ingredient:lifitegrast
Patents:16
Pharmacology for NDA: 208073
Suppliers and Packaging for NDA: 208073
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073 NDA Novartis Pharmaceuticals Corporation 0078-0911 0078-0911-12 12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE
XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073 NDA Novartis Pharmaceuticals Corporation 0078-0911 0078-0911-94 4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength5%
Approval Date:Jul 11, 2016TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 5, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Patent:⤷  Sign UpPatent Expiration:Dec 18, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 10, 2025Product Flag?YSubstance Flag?YDelist Request?

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