Drug application

DANTROLENE SODIUM (DANTROLENE SODIUM)

Drugs@FDA ANDA 076856 · IMPAX LABS

Key facts

Drug name DANTROLENE SODIUM
Active ingredients DANTROLENE SODIUM
Application type ANDA
Application number 076856
Company IMPAX LABS
Dosage forms CAPSULE, ORAL
Strength 25MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 1, 2005

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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

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