Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078290
Company: INVATECH
Company: INVATECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG 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 125MG 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 |
---|---|---|---|---|---|---|---|
07/29/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078290s000ltr.pdf |
DIVALPROEX SODIUM
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 |
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 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 |