Pregabalin

ANDA 209883, held by Strides Pharma. Pregabalin.

As of Nov 13, 2026, ANDA 209883 (Pregabalin), held by Strides Pharma, was first approved by FDA on Jan 24, 2024, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 24, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 24, 2024	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 2 submissions, including labeling and manufacturing supplements


Jul 21, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Jan 24, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 209883
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