grepcent public filings, reorganized for comparison

EMBLAVEO — FDA application NDA217906

Application NDA217906 · type NDA · FDA status: approved · original approval 2025-02-07

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
001EMBLAVEOAVIBACTAM SODIUM; AZTREONAMPOWDERINTRAVENOUSEQ 0.5GM BASE/VIAL;1.5GM/VIALPrescriptionnot 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 7112592001listed patent expiry date: 2026-01-07drug substance, drug product, U-4147
Patent 7612087001listed patent expiry date: 2026-11-12drug product
Patent 8835455001listed patent expiry date: 2030-10-08drug product
Patent 8471025001listed patent expiry date: 2031-08-12drug substance
Patent 8969566001listed patent expiry date: 2032-06-15drug substance
Patent 9284314001listed patent expiry date: 2032-06-15drug substance
Patent 9695122001listed patent expiry date: 2032-06-15drug substance, drug product
Exclusivity NP001listed exclusivity date: 2028-02-07FDA code as listed
Exclusivity GAIN001listed exclusivity date: 2033-02-07FDA code as listed
NDA217906 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217906 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217906 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 marker0.001.002.002025-02-071.002026-01-071.002026-11-121.002028-02-071.002030-10-081.002031-08-121.002032-06-151.002033-02-071.00

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.