Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078979
Company: DR REDDYS LABS LTD
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
01/23/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078979s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/19/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/18/2015 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/18/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/18/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/05/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/05/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/05/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/21/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/07/2010 SUPPL-3 Labeling

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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