Eszopiclone

As of Nov 14, 2026, ANDA 91153 (Eszopiclone), held by Hikma, was first approved by FDA on Apr 15, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 15, 2014
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 15, 2014	Original application	Approved	None posted

Products

3 strengths and forms


Eszopiclone1MG · tablet;oral	Eszopiclone	Discontinued
Eszopiclone2MG · tablet;oral	Eszopiclone	Discontinued
Eszopiclone3MG · tablet;oral	Eszopiclone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Dec 11, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Dec 11, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Dec 11, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jan 30, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Apr 15, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 91153
Drugs@FDA: Overview at FDA
Company: Hikma

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