Drug application

DIVALPROEX SODIUM (DIVALPROEX SODIUM)

Drugs@FDA ANDA 078597 · SUN PHARM INDS

Key facts

Drug name DIVALPROEX SODIUM
Active ingredients DIVALPROEX SODIUM
Application type ANDA
Application number 078597
Company SUN PHARM INDS
Dosage forms TABLET, DELAYED RELEASE, ORAL
Strength EQ 125MG VALPROIC ACID
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 29, 2008

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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