Details for New Drug Application (NDA): 050790
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The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen 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 |
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: | ⤷ Sign Up | Patent Expiration: | Feb 25, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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 MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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