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Details for New Drug Application (NDA): 208073

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NDA 208073 describes XIIDRA, which is a drug marketed by Shire Dev Llc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the XIIDRA profile page.

The generic ingredient in XIIDRA is lifitegrast. One supplier is listed for this compound. Additional details are available on the lifitegrast profile page.

Summary for NDA: 208073

Shire Dev Llc

Pharmacology for NDA: 208073

Suppliers and Packaging for NDA: 208073

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OPHTHALMIC 208073 NDA Shire US Manufacturing Inc. 54092-606 54092-606-01 12 POUCH in 1 CARTON (54092-606-01) > 5 AMPULE in 1 POUCH (54092-606-06) > .2 mL in 1 AMPULE
SOLUTION/DROPS;OPHTHALMIC 208073 NDA Shire US Manufacturing Inc. 54092-606 54092-606-02 12 POUCH in 1 CARTON (54092-606-02) > 5 AMPULE in 1 POUCH (54092-606-07) > .2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength5%
Approval Date:Jul 11, 2016TE:RLD:Yes
Patent:7,314,938Patent Expiration:Mar 10, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:7,928,122Patent Expiration:Nov 5, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:8,084,047Patent Expiration:May 17, 2026Product Flag?YSubstance Flag?YDelist Request?

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