Valproate Sodium

ANDA 78523, held by Hikma Farmaceutica. Valproate Sodium.

First approved: Feb 17, 2010
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 17, 2010	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 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 31, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Mar 31, 2026	Supplement 16Labeling · Standard review	Approved	None posted
Mar 31, 2026	Supplement 20Labeling · Standard review	Approved	None posted
Apr 21, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Apr 21, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Apr 21, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Apr 21, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Apr 21, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Dec 15, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Dec 15, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Dec 15, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Dec 15, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Feb 17, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78523
Drugs@FDA: Overview at FDA
Company: Hikma Farmacêutica

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