Drugs@FDA: FDA-Approved Drugs
Company: ZYDUS PHARMS USA INC
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 |
---|---|---|---|---|---|---|---|
01/27/2009 | 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 |
---|---|---|---|---|---|
07/06/2020 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2020 | SUPPL-24 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2020 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2020 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2020 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2020 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/09/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2015 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/11/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
05/11/2015 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/11/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2014 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2014 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/11/2014 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
02/11/2014 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/11/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/02/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/07/2010 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |