Levetiracetam

ANDA 214673, held by Strides Pharma. Levetiracetam.

As of Nov 15, 2026, ANDA 214673 (Levetiracetam), held by Strides Pharma, was first approved by FDA on Nov 20, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 20, 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
Nov 20, 2023	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam100MG/ML · solution;oral	Levetiracetam	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 13, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Nov 13, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Nov 20, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 214673
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