Pregabalin

ANDA 91025, held by Actavis Elizabeth. Pregabalin.

As of Nov 13, 2026, ANDA 91025 (Pregabalin), held by Actavis Elizabeth, was first approved by FDA on Jul 9, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 9, 2020
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 9, 2020	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 4 submissions, including labeling and manufacturing supplements


Aug 18, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Mar 4, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Jun 9, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 9, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 91025
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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