grepcent public filings, reorganized for comparison

BYVALSON — FDA application NDA206302

Application NDA206302 · type NDA · FDA status: approved · original approval 2016-06-03

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
001BYVALSONNEBIVOLOL HYDROCHLORIDE; VALSARTANTABLETORALEQ 5MG BASE;80MGDiscontinuednot 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 7803838001listed patent expiry date: 2026-08-29drug product
Patent 7838552001listed patent expiry date: 2027-10-04U-185
NDA206302 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA206302 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA206302 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 marker0.001.002.002016-06-031.002026-08-291.002027-10-041.00

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.