Drug application

DURLAZA (ASPIRIN)

Drugs@FDA NDA 200671 · HESP

Key facts

Drug name DURLAZA
Active ingredients ASPIRIN
Application type NDA
Application number 200671
Company HESP
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 162.5MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Sep 4, 2015

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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