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 five suppliers. There are four 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. Twenty 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:	4

Pharmacology for NDA: 050790

Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 050790

Antifungal Agents
Antirheumatic Agents
Calcineurin Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents

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	cyclosporine	EMULSION;OPHTHALMIC	050790	NDA	Allergan, Inc.	0023-9163	0023-9163-12	5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Dec 23, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Oct 27, 2016	TE:		RLD:	Yes
Patent:	8,292,129	Patent Expiration:	Feb 25, 2031	Product Flag?	Y	Substance Flag?		Delist Request?	Y
Patent:	8,561,859	Patent Expiration:	Apr 16, 2032	Product Flag?	Y	Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 050790

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	8,685,930	⤷ Get Started Free
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	8,648,048	⤷ Get Started Free
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	4,839,342	⤷ Get Started Free
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	9,248,191	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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