Pregabalin

ANDA 206752, held by Zydus Pharms. Pregabalin.

As of Nov 13, 2026, ANDA 206752 (Pregabalin), held by Zydus Pharms, was first approved by FDA on Dec 9, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 9, 2022
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
Dec 9, 2022	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


Aug 23, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Dec 9, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 206752
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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