Drugs@FDA: FDA-Approved Drugs
Company: PRINSTON INC
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 |
---|---|---|---|---|---|---|---|
11/30/2009 | 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 |
---|---|---|---|---|---|
11/26/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
11/26/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
11/26/2014 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/26/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/2014 | 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 |