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Details for New Drug Application (NDA): 050790

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

The generic ingredient in RESTASIS is cyclosporine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Summary for NDA: 050790

Tradename:
RESTASIS
Applicant:
Allergan
Ingredient:
cyclosporine
Patents:6
Therapeutic Class:Immunological Agents
Ophthalmic Agents
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Dec 23, 2002TE:RLD:Yes
Patent:8,629,111Patent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,642,556Patent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,685,930Patent Expiration:Aug 27, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 050790

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 20024,839,342► subscribe
Allergan
RESTASIS
cyclosporine
EMULSION;OPHTHALMIC050790-001Dec 23, 20025,474,979► subscribe
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