Drug application

RAMELTEON (RAMELTEON)

Drugs@FDA ANDA 213186 · GRANULES

Key facts

Drug name RAMELTEON
Active ingredients RAMELTEON
Application type ANDA
Application number 213186
Company GRANULES
Dosage forms TABLET, ORAL
Strength 8MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Aug 21, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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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