grepcent public filings, reorganized for comparison

DEPAKOTE — FDA application NDA018723

Application NDA018723 · type NDA · FDA status: approved · original approval 1983-03-10

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
001DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASEORALEQ 250MG VALPROIC ACIDPrescriptionABYes
002DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASEORALEQ 500MG VALPROIC ACIDPrescriptionABYes
003DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASEORALEQ 125MG VALPROIC ACIDPrescriptionABYes

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

No Orange Book patent or exclusivity listings joined to this application.

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.