Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050790

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RESTASIS (CYCLOSPORINE)
0.05%
Marketing Status: Prescription

Active Ingredient: CYCLOSPORINE
Proprietary Name: RESTASIS
Dosage Form; Route of Administration: EMULSION; OPHTHALMIC
Strength: 0.05%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050790
Product Number: 001
Approval Date: Dec 23, 2002
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RESTASIS MULTIDOSE (CYCLOSPORINE)
0.05%
Marketing Status: Prescription

Active Ingredient: CYCLOSPORINE
Proprietary Name: RESTASIS MULTIDOSE
Dosage Form; Route of Administration: EMULSION; OPHTHALMIC
Strength: 0.05%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050790
Product Number: 002
Approval Date: Oct 27, 2016
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information