Pregabalin

ANDA 215755, held by Strides Pharma. Pregabalin.

As of Nov 14, 2026, ANDA 215755 (Pregabalin), held by Strides Pharma, was first approved by FDA on Apr 26, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2023
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 26, 2023	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


Sep 30, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Dec 9, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Apr 26, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 215755
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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