Drug application

KETOPROFEN (KETOPROFEN)

Drugs@FDA ANDA 075679 · MYLAN

Key facts

Drug name KETOPROFEN
Active ingredients KETOPROFEN
Application type ANDA
Application number 075679
Company MYLAN
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 200MG
Marketing status Prescription
Reference listed drug No
Latest submission status date Feb 20, 2002

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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