Lypqozet

ANDA 206084, held by Pharmobedient. Atorvastatin Calcium; Ezetimibe.

As of Nov 15, 2026, ANDA 206084 (Lypqozet), held by Pharmobedient, was first approved by FDA on Apr 26, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 26, 2017	Original application	Approved	Letter

Products

4 strengths and forms


LypqozetEQ 10MG BASE;10MG · tablet;oral	Atorvastatin Calcium; Ezetimibe	Discontinued
LypqozetEQ 20MG BASE;10MG · tablet;oral	Atorvastatin Calcium; Ezetimibe	Discontinued
LypqozetEQ 40MG BASE;10MG · tablet;oral	Atorvastatin Calcium; Ezetimibe	Discontinued
LypqozetEQ 80MG BASE;10MG · tablet;oral	Atorvastatin Calcium; Ezetimibe	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Feb 16, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Jan 15, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Jan 13, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Jan 13, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Jan 13, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Apr 26, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 206084
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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