cyclosporine

FDA Drug Profile — Cyclosporine, RESTASIS, Neoral, Sandimmune, Verkazia

cyclosporine is listed in the FDA National Drug Code directory with 31 NDC codes, marketed under brand names including Cyclosporine, RESTASIS, Neoral. Available dosage forms: emulsion, injection, capsule, liquid filled, solution, solution/ drops.

Drug Details

Generic Name
cyclosporine
Brand Names
Cyclosporine, RESTASIS, Neoral, Sandimmune, Verkazia, CYCLOSPORINE, CEQUA, Restasis MultiDose
Application Number
ANDA209811
Sponsor
Devatis Inc.
NDC Codes
31
Dosage Forms
EMULSION, INJECTION, CAPSULE, LIQUID FILLED, SOLUTION, SOLUTION/ DROPS
Routes
OPHTHALMIC, ORAL, INTRAVENOUS, TOPICAL
Active Ingredients
CYCLOSPORINE

Indications and Usage

1 INDICATIONS AND USAGE Cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine ophthalmic emulsion, 0.05% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. ( 1 )