NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE — FDA application ANDA076518
Listed sponsor: PERRIGO · PRGO 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
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | ORAL | 220MG;120MG | Over-the-counter | not listed | No |
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
- NAPROXEN SODIUM · UNII 9TN87S3A3C · lmmol compound CDBRNDSHEYLDJV-FVGYRXGTSA-M · CHEMBL1200806
- PSEUDOEPHEDRINE HYDROCHLORIDE · UNII 6V9V2RYJ8N · lmmol compound BALXUFOVQVENIU-KXNXZCPBSA-N · CHEMBL1200724
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.