Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078239
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED 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
02/27/2009 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
11/30/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

11/30/2015 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/19/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/19/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/19/2014 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/19/2014 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/19/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/19/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/04/2009 SUPPL-2

Label is not available on this site.

08/04/2009 SUPPL-1 Labeling

Label is not available on this site.

DIVALPROEX SODIUM

TABLET, EXTENDED 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 ER DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021168 ABBVIE
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203730 AMNEAL PHARMS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078445 ANCHEN PHARMS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202419 AUROBINDO PHARMA LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090161 DR REDDYS LABS LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078791 IMPAX LABS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077567 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078705 WOCKHARDT
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078239 ZYDUS PHARMS USA INC

TABLET, EXTENDED 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 ER DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021168 ABBVIE
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203730 AMNEAL PHARMS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078445 ANCHEN PHARMS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202419 AUROBINDO PHARMA LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078791 IMPAX LABS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077567 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090070 REDDYS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078705 WOCKHARDT
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078239 ZYDUS PHARMS USA INC

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