grepcent public filings, reorganized for comparison

REXTOVY — FDA application NDA208969

Application NDA208969 · type NDA · FDA status: approved · original approval 2023-03-07

Listed sponsor: AMPHASTAR PHARMS INC · AMPH 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
001REXTOVYNALOXONE HYDROCHLORIDESPRAY, METEREDNASAL4MG/SPRAYOver-the-counternot 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
Exclusivity NP001listed exclusivity date: 2026-03-07FDA code as listed
NDA208969 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208969 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208969 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 marker0.001.002.002023-03-071.002026-03-071.00

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: 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.