Drug application

TEMAZEPAM (TEMAZEPAM)

Drugs@FDA ANDA 203482 · AMNEAL PHARMS

Key facts

Drug name TEMAZEPAM
Active ingredients TEMAZEPAM
Application type ANDA
Application number 203482
Company AMNEAL PHARMS
Dosage forms CAPSULE, ORAL
Strength 7.5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 23, 2016

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

Browse all Drugs@FDA applications