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Valproate Sodium

ANDA 208120, held by Pharmobedient. Valproate Sodium.

  • First approved: Dec 22, 2021
  • Review: Standard
  • Supplements approved: 1
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below
DateSubmissionStatusDocuments
Dec 22, 2021Original applicationApprovedNone posted

Products

1 strengths and forms
ProductActive ingredientMarketing
Valproate SodiumEQ 100MG BASE/ML · injectable;injectionValproate SodiumDiscontinued
All 2 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Mar 31, 2026Supplement 1Labeling · Standard reviewApprovedNone posted
Dec 22, 2021Original applicationApprovedNone posted

Identifiers

Application
ANDA 208120

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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.