grepcent public filings, reorganized for comparison

DUZALLO — FDA application NDA209203

Application NDA209203 · type NDA · FDA status: approved · original approval 2017-08-18

Listed sponsor: IRONWOOD PHARMS INC · IRWD 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
001DUZALLOALLOPURINOL; LESINURADTABLETORAL200MG;200MGDiscontinuednot listedYes
002DUZALLOALLOPURINOL; LESINURADTABLETORAL300MG;200MGDiscontinuednot 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 10183012001listed patent expiry date: 2028-11-26U-2104
Patent 10183012002listed patent expiry date: 2028-11-26U-2104
Patent 8283369001listed patent expiry date: 2028-11-26U-2104
Patent 8283369002listed patent expiry date: 2028-11-26U-2104
Patent 8546437001listed patent expiry date: 2029-04-29U-2104
Patent 8546437002listed patent expiry date: 2029-04-29U-2104
Patent 8084483001listed patent expiry date: 2029-08-17U-2104
Patent 8084483002listed patent expiry date: 2029-08-17U-2104
Patent 8357713001listed patent expiry date: 2029-12-22drug product, U-2104
Patent 8357713002listed patent expiry date: 2029-12-22drug product, U-2104
Patent 9216179001listed patent expiry date: 2031-08-01U-2104
Patent 9216179002listed patent expiry date: 2031-08-01U-2104
Patent 9956205001listed patent expiry date: 2031-12-28U-2104
Patent 9956205002listed patent expiry date: 2031-12-28U-2104
Patent 8546436001listed patent expiry date: 2032-02-29drug substance
Patent 8546436002listed patent expiry date: 2032-02-29drug substance
NDA209203 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209203 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209203 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 marker0.001.002.002017-08-181.002028-11-261.002029-04-291.002029-08-171.002029-12-221.002031-08-011.002031-12-281.002032-02-291.00

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: No published peer-cluster link for this sponsor.

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.