grepcent public filings, reorganized for comparison

DEFENCATH — FDA application NDA214520

Application NDA214520 · type NDA · FDA status: approved · original approval 2023-11-15

Listed sponsor: CORMEDIX · CRMD 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
001DEFENCATHHEPARIN SODIUM; TAUROLIDINESOLUTIONN/A3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)Prescriptionnot listedYes
002DEFENCATHHEPARIN SODIUM; TAUROLIDINESOLUTIONN/A5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)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 7696182001listed patent expiry date: 2026-05-16drug substance, drug product, U-3774
Patent 7696182002listed patent expiry date: 2026-05-16drug substance, drug product, U-3774
Patent 11738120001listed patent expiry date: 2042-04-15drug substance, drug product
Patent 11738120002listed patent expiry date: 2042-04-15drug substance, drug product
Exclusivity NCE001listed exclusivity date: 2028-11-15FDA code as listed
Exclusivity NCE002listed exclusivity date: 2028-11-15FDA code as listed
Exclusivity GAIN001listed exclusivity date: 2033-11-15FDA code as listed
Exclusivity GAIN002listed exclusivity date: 2033-11-15FDA code as listed
NDA214520 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA214520 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA214520 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 marker0.001.002.002023-11-151.002026-05-161.002028-11-151.002033-11-151.002042-04-151.00

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.