Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077567
Company: MYLAN
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 Prescription AB No No
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
01/29/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077567s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077567s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2015 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/22/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/22/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/13/2014 SUPPL-10 Labeling-Medication Guide

Label is not available on this site.

09/13/2014 SUPPL-9 Labeling-Medication Guide

Label is not available on this site.

09/13/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/10/2010 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077567s000lbl.pdf

DIVALPROEX SODIUM

TABLET, EXTENDED RELEASE;ORAL; EQ 250MG VALPROIC ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPAKOTE ER DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021168 ABBVIE
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203730 AMNEAL PHARMS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202419 AUROBINDO PHARMA LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090161 DR REDDYS LABS LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078791 IMPAX LABS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209286 LUPIN LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077567 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078705 WOCKHARDT
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078239 ZYDUS PHARMS USA INC

TABLET, EXTENDED RELEASE;ORAL; EQ 500MG VALPROIC ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPAKOTE ER DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021168 ABBVIE
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203730 AMNEAL PHARMS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202419 AUROBINDO PHARMA LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078791 IMPAX LABS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209286 LUPIN LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077567 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090070 REDDYS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078705 WOCKHARDT
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078239 ZYDUS PHARMS USA INC

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