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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 050790


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NDA 050790 describes RESTASIS MULTIDOSE, which is a drug marketed by Abbvie and is included in one NDA. It is available from four 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. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 050790
Tradename:RESTASIS MULTIDOSE
Applicant:Abbvie
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 0023-5301-05 1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLE
RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790 NDA Allergan, Inc. 0023-5301 0023-5301-05 1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Dec 23, 2002TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Oct 27, 2016TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 25, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Apr 16, 2032Product Flag?YSubstance Flag?Delist Request?

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