Pregabalin

ANDA 213313, held by Apotex. Pregabalin.

As of Nov 14, 2026, ANDA 213313 (Pregabalin), held by Apotex, was first approved by FDA on Apr 13, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 13, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 13, 2021	Original application	Approved	None posted

Products

2 strengths and forms


Pregabalin165MG · tablet, extended release;oral	Pregabalin	Discontinued
Pregabalin330MG · tablet, extended release;oral	Pregabalin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 2, 2026	Supplement 2Labeling · Standard review	Approved	None posted
May 30, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Apr 13, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 213313
Drugs@FDA: Overview at FDA
Company: Apotex

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