Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077615
Company: APOTEX
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/2008/077615s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/22/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/22/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/22/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/22/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/16/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/16/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/16/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/21/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 079080 ACTAVIS LABS FL INC
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 078411 ANCHEN PHARMS
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 CELLTRION
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 078790 LUPIN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 090062 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 078853 ORCHID HLTHCARE
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 078290 SANDOZ
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 CELLTRION
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 078790 LUPIN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 090062 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 078853 ORCHID HLTHCARE
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 078290 SANDOZ
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 CELLTRION
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 078790 LUPIN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 090062 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Prescription No AB 078853 ORCHID HLTHCARE
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 078290 SANDOZ
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

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