Details for New Drug Application (NDA): 050790
✉ Email this page to a colleague
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 |
Pharmacology for NDA: 050790
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 050790
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. | 0023-5301 | 0023-5301-08 | 1 BOTTLE in 1 CARTON (0023-5301-08) / 5.5 mL in 1 BOTTLE |
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: | ⤷ Try a Trial | Patent Expiration: | Feb 25, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 16, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 050790
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription