Ezetimibe And Simvastatin

ANDA 202968, held by Watson Labs Inc. Ezetimibe; Simvastatin.

As of Nov 15, 2026, ANDA 202968 (Ezetimibe And Simvastatin), held by Watson Labs Inc, was first approved by FDA on Apr 26, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2017
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	None posted

Products

4 strengths and forms


Ezetimibe And Simvastatin10MG;10MG · tablet;oral	Ezetimibe; Simvastatin	Discontinued
Ezetimibe And Simvastatin10MG;20MG · tablet;oral	Ezetimibe; Simvastatin	Discontinued
Ezetimibe And Simvastatin10MG;40MG · tablet;oral	Ezetimibe; Simvastatin	Discontinued
Ezetimibe And Simvastatin10MG;80MG · tablet;oral	Ezetimibe; Simvastatin	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 29, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Oct 1, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jan 24, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Apr 26, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 202968
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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