Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019680
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPAKOTE | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/12/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019680s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018723Orig1s068; 019680Orig1s055; 021168Orig1s046ltr.pdf | |
| 02/24/2023 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019680s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018723Orig1s066;019680Orig1s053;021168Orig1s044ltr.pdf | |
| 11/30/2021 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018723Orig1s065;019680Orig1s052;021168Orig1s043ltr.pdf | |
| 02/10/2021 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018723Orig1s064, 019680Orig1s051, 021168Orig1s042ltr.pdf | |
| 05/19/2020 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019680s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018081Orig1s071,018082Orig1s054,018723Orig1s063,019680Orig1s050,020593Orig1s041,021168Orig1s041ltr.pdf | |
| 11/22/2019 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019680s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018081Orig1s070, 018082Orig1s053, 018723Orig1s062, 019680Orig1s049, 020593Orig1s040, 021168Orig1s040ltr.pdf | |
| 02/21/2019 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019680s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018081Orig1s069,018082Orig1s052,018723Orig1s061,019680Orig1s048,020593Orig1s039,021168Orig1s039ltr.pdf | |
| 03/06/2018 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019680s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018081Orig1s068,018082Orig1s051,018723Orig1s060,019680Orig1s047,020593Orig1s038,021168Orig1s038RPLltr.pdf | |
| 10/05/2017 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019680s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s067,018082Orig1s050,018723Orig1s059,019680Orig1s046,020593Orig1s037,021168Origs037ltr.pdf | |
| 03/06/2017 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019680s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018081Orig1s066,018082Orig1s049,018723Orig1s058,019680Orig1s045,020593Orig1s036,021168Orig1s036ltr.pdf | |
| 11/02/2016 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s065,018082Orig1s048,018723Orig1s057,019680Orig1s044,020593Orig1s035,021168Orig1s035ltr.pdf | |
| 02/18/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf | |
| 09/23/2015 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s042lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf | |
| 03/13/2015 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf | |
| 08/20/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf | |
| 06/09/2014 | SUPPL-39 | 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-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf | |
| 11/20/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf | |
| 06/14/2013 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s036lbl.pdf | |
| 07/31/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf | |
| 02/27/2013 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s034lblupdated.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf | |
| 06/20/2014 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019680Orig1s033ltr.pdf | |
| 10/07/2011 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf | |
| 10/07/2011 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf | |
| 06/19/2014 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf | |
| 10/07/2011 | SUPPL-27 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf | |
| 04/23/2009 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019680s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019680s026ltr.pdf | |
| 10/07/2011 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf | |
| 03/24/2008 | SUPPL-24 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 10/13/2006 | SUPPL-22 | 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 | |
| 12/19/2006 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019680s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s021ltr.pdf | |
| 01/11/2006 | SUPPL-19 | 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/2006/019680s019ltr.pdf | |
| 11/05/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/2002 | SUPPL-15 | Labeling |
Letter
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 |
| 06/19/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/23/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019680s055lbl.pdf | |
| 02/24/2023 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019680s053lbl.pdf | |
| 11/30/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s052lbl.pdf | |
| 02/10/2021 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s051lbl.pdf | |
| 05/19/2020 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019680s050lbl.pdf | |
| 11/22/2019 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019680s049lbl.pdf | |
| 02/21/2019 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019680s048lbl.pdf | |
| 03/06/2018 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019680s047lbl.pdf | |
| 10/05/2017 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019680s046lbl.pdf | |
| 03/06/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019680s045lbl.pdf | |
| 11/02/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s044lbl.pdf | |
| 02/18/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s043lbl.pdf | |
| 09/23/2015 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s042lbledt.pdf | |
| 03/13/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf | |
| 01/07/2015 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s038lbl.pdf | |
| 11/20/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s037lbl.pdf | |
| 08/20/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s040lbl.pdf | |
| 06/20/2014 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s033lbl.pdf | |
| 06/19/2014 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s028lbl.pdf | |
| 06/09/2014 | SUPPL-39 | 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-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s035lbl.pdf | |
| 06/14/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s036lbl.pdf | |
| 02/27/2013 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s034lblupdated.pdf | |
| 10/07/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf | |
| 10/07/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf | |
| 10/07/2011 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf | |
| 10/07/2011 | SUPPL-27 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf | |
| 10/07/2011 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf | |
| 04/23/2009 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019680s026lbl.pdf | |
| 12/19/2006 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019680s021lbl.pdf | |
| 10/13/2006 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf | |
| 01/11/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf |
DEPAKOTE
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 125MG VALPROIC ACID
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEPAKOTE | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 019680 | ABBVIE |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213181 | AJANTA PHARMA LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078979 | DR REDDYS LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078919 | ZYDUS PHARMS USA INC |