ROSZETezetimibe, rosuvastatin calcium

FDA approved the original new drug application for ROSZET on March 23, 2021, sponsored by ALTHERA PHARMS. FDA marks all 4 products under the application discontinued. FDA has approved 1 efficacy supplement on the application since, the most recent on August 26, 2024.

Application

NDA213072

Sponsor

ALTHERA PHARMS

Original approval

March 23, 2021

Review

standard review

Submission class

Type 4 - New Combination

Active ingredient

ezetimibe, rosuvastatin calcium

Browse every approval whose brand starts with R, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

What “discontinued” means in FDA’s record

Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.

Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.