grepcent public filings, reorganized for comparison

RESTASIS / RESTASIS MULTIDOSE — FDA application NDA050790

Application NDA050790 · type NDA · FDA status: approved · original approval 2002-12-23

Listed sponsor: ABBVIE · ABBV company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001RESTASISCYCLOSPORINEEMULSIONOPHTHALMIC0.05%PrescriptionABYes
002RESTASIS MULTIDOSECYCLOSPORINEEMULSIONOPHTHALMIC0.05%Prescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 8292129002listed patent expiry date: 2031-02-25drug product
Patent 8561859002listed patent expiry date: 2032-04-16drug product
Patent 9676525002listed patent expiry date: 2034-02-07drug product
Patent 9669974002listed patent expiry date: 2034-05-11drug product
NDA050790 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA050790 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA050790 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002002-12-231.002031-02-251.002032-04-161.002034-02-071.002034-05-111.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Compound cross-links

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Related pages

Sponsor company · FDA-approved application index

Peer clusters: Large-cap biopharma

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.