Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077567
Company: MYLAN
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 |
|---|---|---|---|---|---|
| 10/23/2023 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2023 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2023 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2023 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2020 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2020 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2020 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 | 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 |
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 |