Pregabalin

ANDA 211687, held by Alvogen. Pregabalin.

As of Nov 14, 2026, ANDA 211687 (Pregabalin), held by Alvogen, was first approved by FDA on Jul 6, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 6, 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 6, 2021	Original application	Approved	None posted

Products

3 strengths and forms


Pregabalin82.5MG · tablet, extended release;oral	Pregabalin	Discontinued
Pregabalin165MG · tablet, extended release;oral	Pregabalin	Discontinued
Pregabalin330MG · tablet, extended release;oral	Pregabalin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 17, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Mar 6, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jul 6, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 211687
Drugs@FDA: Overview at FDA
Company: Alvogen

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