Valproate Sodium

ANDA 76295, held by Sagent. Valproate Sodium.

First approved: Nov 14, 2002
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 14, 2002	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 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 31, 2026	Supplement 16Labeling · Standard review	Approved	None posted
Oct 24, 2007	Supplement 4Labeling	Approved	None posted
Nov 14, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76295
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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