Brivaracetam

ANDA 214918, held by Lupin. Brivaracetam.

As of Nov 15, 2026, ANDA 214918 (Brivaracetam), held by Lupin, was first approved by FDA on Dec 20, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 20, 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 20, 2022	Original application	Approved	Letter

Products

5 strengths and forms


Brivaracetam10MG · tablet;oral	Brivaracetam	Discontinued
Brivaracetam25MG · tablet;oral	Brivaracetam	Discontinued
Brivaracetam50MG · tablet;oral	Brivaracetam	Discontinued
Brivaracetam75MG · tablet;oral	Brivaracetam	Discontinued
Brivaracetam100MG · tablet;oral	Brivaracetam	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 26, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Dec 20, 2022	Original application	Approved	Letter

Identifiers

Application: ANDA 214918
Drugs@FDA: Overview at FDA
Company: Lupin

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