Drug application

DIVALPROEX SODIUM (DIVALPROEX SODIUM)

Drugs@FDA ANDA 078979 · DR REDDYS LABS LTD

Key facts

Drug name DIVALPROEX SODIUM
Active ingredients DIVALPROEX SODIUM
Application type ANDA
Application number 078979
Company DR REDDYS LABS LTD
Dosage forms CAPSULE, DELAYED REL PELLETS, ORAL
Strength EQ 125MG VALPROIC ACID
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jan 23, 2009

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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