# LIPTRUZET — FDA application NDA200153

Informational only - not investment advice.

Application NDA200153 · type NDA · FDA status: approved · original approval 2013-05-03

Listed sponsor: ORGANON · [OGN company profile](/company/OGN/) · 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 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET | ORAL | EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |
| 002 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET | ORAL | EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |
| 003 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET | ORAL | EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |
| 004 | LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | TABLET | ORAL | EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |

## Orange Book patent and exclusivity listings

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

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

- ATORVASTATIN CALCIUM; EZETIMIBE · UNII not resolved · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/OGN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA200153. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.