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Generated: November 18, 2018

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Details for New Drug Application (NDA): 050790

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NDA 050790 describes RESTASIS MULTIDOSE, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug. Additional details are available on the RESTASIS MULTIDOSE profile page.

The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are eighteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 050790
Tradename:RESTASIS MULTIDOSE
Applicant:Allergan
Ingredient:cyclosporine
Patents:10
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 050790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790 NDA Allergan, Inc. 0023-5301 0023-5301-01 1 BOTTLE in 1 CARTON (0023-5301-01) > 1.5 mL in 1 BOTTLE
RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790 NDA Allergan, Inc. 0023-5301 0023-5301-01 1 BOTTLE in 1 CARTON (0023-5301-01) > 1.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Dec 23, 2002TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Aug 27, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
Patent:➤ Sign UpPatent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 050790

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 ➤ Sign Up ➤ Sign Up
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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