Roszet

NDA 213072, held by Althera Pharms. Ezetimibe; Rosuvastatin Calcium.

As of Nov 14, 2026, NDA 213072 (Roszet), held by Althera Pharms, was first approved by FDA on Mar 23, 2021, with 1 approved supplement and 1 published complete response letter.

First approved: Mar 23, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 1

Approvals and New Uses

The original application and every efficacy supplement, newest first


Aug 26, 2024	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 23, 2021	Original applicationNew combination · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
May 26, 2020	Rosuvastatin and ezetimibeProduct Quality, Facility Inspections, Information Needed To Resolve Deficiencies	Approved

Products

4 strengths and forms


Roszet10MG;EQ 5MG BASE · tablet;oral	Ezetimibe; Rosuvastatin Calcium	DiscontinuedReference drug
Roszet10MG;EQ 10MG BASE · tablet;oral	Ezetimibe; Rosuvastatin Calcium	DiscontinuedReference drug
Roszet10MG;EQ 20MG BASE · tablet;oral	Ezetimibe; Rosuvastatin Calcium	DiscontinuedReference drug
Roszet10MG;EQ 40MG BASE · tablet;oral	Ezetimibe; Rosuvastatin Calcium	DiscontinuedReference drug

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: RoszetJun 2, 2022

Identifiers

Application: NDA 213072
Drugs@FDA: Overview at FDA
Company: Althera Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters