Drug application

SEYSARA (SARECYCLINE HYDROCHLORIDE)

Drugs@FDA NDA 209521 · ALMIRALL

Key facts

Drug name SEYSARA
Active ingredients SARECYCLINE HYDROCHLORIDE
Application type NDA
Application number 209521
Company ALMIRALL
Dosage forms TABLET, ORAL
Strength EQ 60MG BASE
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Oct 1, 2018

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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