Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078791
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/06/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2020 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/21/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

01/21/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

01/21/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/21/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/16/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/04/2009 SUPPL-2 Labeling

Label is not available on this site.

08/04/2009 SUPPL-1

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English