Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090554
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED 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 |
|---|---|---|---|---|---|---|---|
| 04/21/2011 | 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 |
|---|---|---|---|---|---|
| 12/27/2023 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2023 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2021 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
DIVALPROEX SODIUM
TABLET, DELAYED RELEASE;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 | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 018723 | ABBVIE |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077615 | APOTEX |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090554 | AUROBINDO PHARMA LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077296 | CHARTWELL RX |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078755 | DR REDDYS LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078290 | INVATECH |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078790 | LUPIN |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078853 | ORBION PHARMS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090210 | PRINSTON INC |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078597 | SUN PHARM INDS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 079163 | UNICHEM LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078182 | UPSHER SMITH LABS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077100 | ZYDUS PHARMS USA INC |
TABLET, DELAYED 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 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 018723 | ABBVIE |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077615 | APOTEX |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090554 | AUROBINDO PHARMA LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077296 | CHARTWELL RX |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078755 | DR REDDYS LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078290 | INVATECH |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078790 | LUPIN |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078853 | ORBION PHARMS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090210 | PRINSTON INC |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078597 | SUN PHARM INDS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 079163 | UNICHEM LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078182 | UPSHER SMITH LABS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077100 | ZYDUS PHARMS USA INC |
TABLET, DELAYED 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 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 018723 | ABBVIE |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077615 | APOTEX |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090554 | AUROBINDO PHARMA LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077296 | CHARTWELL RX |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078755 | DR REDDYS LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078290 | INVATECH |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078790 | LUPIN |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078853 | ORBION PHARMS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090210 | PRINSTON INC |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078597 | SUN PHARM INDS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 079163 | UNICHEM LABS LTD |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078182 | UPSHER SMITH LABS |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077100 | ZYDUS PHARMS USA INC |