Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078919
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
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-Package Insert, Labeling-Medication Guide

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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/11/2014 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

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-Package Insert, Labeling-Medication Guide, 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 078979 DR REDDYS LABS LTD
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090407 MYLAN
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078919 ZYDUS PHARMS USA INC

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