Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021168
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPAKOTE ER | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| DEPAKOTE ER | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21168ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-168_Depakote.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021168s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018723Orig1s068; 019680Orig1s055; 021168Orig1s046ltr.pdf | |
| 02/24/2023 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021168s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018723Orig1s066;019680Orig1s053;021168Orig1s044ltr.pdf | |
| 11/30/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018723Orig1s065;019680Orig1s052;021168Orig1s043ltr.pdf | |
| 02/10/2021 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018723Orig1s064, 019680Orig1s051, 021168Orig1s042ltr.pdf | |
| 05/19/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021168s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018081Orig1s071,018082Orig1s054,018723Orig1s063,019680Orig1s050,020593Orig1s041,021168Orig1s041ltr.pdf | |
| 11/22/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021168s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018081Orig1s070, 018082Orig1s053, 018723Orig1s062, 019680Orig1s049, 020593Orig1s040, 021168Orig1s040ltr.pdf | |
| 02/21/2019 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021168s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018081Orig1s069,018082Orig1s052,018723Orig1s061,019680Orig1s048,020593Orig1s039,021168Orig1s039ltr.pdf | |
| 03/06/2018 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021168s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf | |
| 10/05/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf | |
| 03/06/2017 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf | |
| 11/02/2016 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf | |
| 05/12/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf | |
| 09/23/2015 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf | |
| 03/13/2015 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf | |
| 03/20/2015 | SUPPL-30 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021168Orig1s030ltr.pdf | |
| 08/20/2014 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf | |
| 06/09/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf | |
| 01/07/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf | |
| 11/20/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf | |
| 06/14/2013 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s025lbl.pdf | |
| 07/31/2013 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf | |
| 02/27/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf | |
| 10/07/2011 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf | |
| 10/07/2011 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf | |
| 06/19/2014 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf | |
| 04/23/2009 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021168s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021168s018ltr.pdf | |
| 10/07/2011 | SUPPL-17 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf | |
| 10/07/2011 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf | |
| 03/24/2008 | SUPPL-15 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021168s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021168s015ltr.pdf | |
| 10/13/2006 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf | |
| 12/06/2005 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021168s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021168s012ltr.pdf | |
| 01/11/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021168s009ltr.pdf | |
| 04/20/2003 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2003 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21168se5-007_depakote_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21168se5-007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021168_S007_DepakoteTOC.cfm | |
| 12/20/2002 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20782,21168slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021168_S004_DepakoteTOC.cfm | |
| 12/12/2002 | SUPPL-3 | Labeling |
Letter
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 |
| 05/31/2002 | SUPPL-1 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21168s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21168s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021168s046lbl.pdf | |
| 02/24/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021168s044lbl.pdf | |
| 11/30/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s043lbl.pdf | |
| 02/10/2021 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s042lbl.pdf | |
| 05/19/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021168s041lbl.pdf | |
| 11/22/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021168s040lbl.pdf | |
| 02/21/2019 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021168s039lbl.pdf | |
| 03/06/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021168s038lbl.pdf | |
| 10/05/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s037lbl.pdf | |
| 03/06/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021168s036lbl.pdf | |
| 11/02/2016 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s035lbl.pdf | |
| 02/18/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s033lbl.pdf | |
| 09/23/2015 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s032lbl.pdf | |
| 03/20/2015 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168Orig1s030lbl.pdf | |
| 03/13/2015 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s031lbl.pdf | |
| 01/07/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s027lbl.pdf | |
| 11/20/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s026lbl.pdf | |
| 08/20/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s029lbl.pdf | |
| 06/19/2014 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s019lbl.pdf | |
| 06/09/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf | |
| 07/31/2013 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s024lbl.pdf | |
| 06/14/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s025lbl.pdf | |
| 02/27/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s023lbl.pdf | |
| 10/07/2011 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf | |
| 10/07/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf | |
| 10/07/2011 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf | |
| 10/07/2011 | SUPPL-17 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf | |
| 10/07/2011 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf | |
| 04/23/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021168s018lbl.pdf | |
| 03/24/2008 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021168s015lbl.pdf | |
| 10/13/2006 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf | |
| 01/11/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf | |
| 12/06/2005 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021168s012lbl.pdf | |
| 08/14/2003 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21168se5-007_depakote_lbl.pdf | |
| 12/20/2002 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf | |
| 05/31/2002 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21168s1lbl.pdf |
| 08/04/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21168lbl.pdf |
DEPAKOTE ER
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 | 215527 | ANNORA PHARMA |
| 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 | 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 | 214643 | UNICHEM |
| 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 |
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 | 215527 | ANNORA PHARMA |
| 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 | 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 | 214643 | UNICHEM |
| 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 |