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-one suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are eighteen drug master file entries for this compound. Twenty-one 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
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: | ⤷ Start Trial | Patent Expiration: | Feb 25, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 16, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
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 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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