EZETIMIBE AND SIMVASTATIN — FDA application ANDA208831
Listed sponsor: AMNEAL PHARMS CO · AMRX 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 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET | ORAL | 10MG;10MG | Discontinued | not listed | No |
| 002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET | ORAL | 10MG;20MG | Discontinued | not listed | No |
| 003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET | ORAL | 10MG;40MG | Discontinued | not listed | No |
| 004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET | ORAL | 10MG;80MG | Discontinued | 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
- EZETIMIBE · UNII EOR26LQQ24 · lmmol compound OLNTVTPDXPETLC-XPWALMASSA-N · CHEMBL1138
- SIMVASTATIN · UNII AGG2FN16EV · lmmol compound RYMZZMVNJRMUDD-HGQWONQESA-N · CHEMBL1064
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.