Pregabalin

ANDA 211685, held by Apotex. Pregabalin.

As of Nov 13, 2026, ANDA 211685 (Pregabalin), held by Apotex, was first approved by FDA on Jul 7, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 7, 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
Jul 7, 2021	Original application	Approved	None posted

Products

8 strengths and forms


Pregabalin25MG · capsule;oral	Pregabalin	Discontinued
Pregabalin50MG · capsule;oral	Pregabalin	Discontinued
Pregabalin75MG · capsule;oral	Pregabalin	Discontinued
Pregabalin100MG · capsule;oral	Pregabalin	Discontinued
Pregabalin150MG · capsule;oral	Pregabalin	Discontinued
Pregabalin200MG · capsule;oral	Pregabalin	Discontinued
Pregabalin225MG · capsule;oral	Pregabalin	Discontinued
Pregabalin300MG · capsule;oral	Pregabalin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 18, 2025	Supplement 2Labeling · Standard review	Approved	None posted
May 30, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jul 7, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 211685
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