grepcent public filings, reorganized for comparison

NAMENDA XR — FDA application NDA022525

Application NDA022525 · type NDA · FDA status: approved · original approval 2010-06-21

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
001NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORAL7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinuednot listedYes
002NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORAL14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinuednot listedYes
003NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORAL21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinuednot listedYes
004NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORAL28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinuednot listedYes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 8039009001listed patent expiry date: 2029-03-24U-539
Patent 8039009002listed patent expiry date: 2029-03-24U-539
Patent 8039009003listed patent expiry date: 2029-03-24U-539
Patent 8039009004listed patent expiry date: 2029-03-24U-539
Patent 8039009001listed patent expiry date: 2029-09-24pediatric extension
Patent 8039009002listed patent expiry date: 2029-09-24pediatric extension
Patent 8039009003listed patent expiry date: 2029-09-24pediatric extension
Patent 8039009004listed patent expiry date: 2029-09-24pediatric extension
NDA022525 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA022525 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA022525 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 marker0.001.002.002010-06-211.002029-03-241.002029-09-241.00

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.