Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 01/23/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078979s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/2023 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2023 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/11/2023 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/06/2020 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/19/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2016 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/18/2015 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2014 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2010 | SUPPL-3 | Labeling |
Label is not available on this site. |
DIVALPROEX SODIUM
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 |