Divalproex Sodium

ANDA 214462, held by Yichang Humanwell. Divalproex Sodium.

As of Nov 14, 2026, ANDA 214462 (Divalproex Sodium), held by Yichang Humanwell, was first approved by FDA on Mar 15, 2021, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 15, 2021
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 15, 2021	Original application	Approved	None posted

Products

2 strengths and forms


Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	Discontinued
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, extended release;oral	Divalproex Sodium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 29, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Jan 29, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Jul 10, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jun 8, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Mar 15, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 214462
Drugs@FDA: Overview at FDA
Company: Yichang Humanwell Pharmaceutical

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