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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090161
Company: DR REDDYS LABS LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/15/2012 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
02/21/2020 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/28/2016 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/28/2016 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/28/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/22/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/22/2014 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/22/2014 SUPPL-1 Labeling-Package Insert

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 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 209286 LUPIN LTD
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 214643 UNICHEM
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
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