Pregabalin

ANDA 215249, held by Rubicon Research. Pregabalin.

As of Nov 14, 2026, ANDA 215249 (Pregabalin), held by Rubicon Research, was first approved by FDA on Mar 22, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 22, 2022	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Dec 12, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Dec 12, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Mar 22, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215249
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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