Drug application

IBUPROFEN (IBUPROFEN)

Drugs@FDA ANDA 076117 · DR REDDYS LABS INC

Key facts

Drug name IBUPROFEN
Active ingredients IBUPROFEN
Application type ANDA
Application number 076117
Company DR REDDYS LABS INC
Dosage forms TABLET, ORAL
Strength 200MG
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Nov 20, 2001

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None 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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