Valproate Sodium

ANDA 76539, held by Fresenius Kabi USA. Valproate Sodium.

First approved: Jun 26, 2003
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jun 26, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Valproate SodiumEQ 100MG BASE/ML · injectable;injection	Valproate Sodium	Rx

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 31, 2026	Supplement 23Labeling · Standard review	Approved	None posted
Apr 4, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Apr 4, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Oct 11, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Dec 22, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Dec 22, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Dec 22, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Dec 22, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Dec 22, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jun 26, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76539
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters