Orange Book product

IBUPROFEN 600MG

Orange Book ANDA 075682 · DR REDDYS LABORATORIES INC · Prescription

Key facts

Proprietary name IBUPROFEN
Active ingredients IBUPROFEN
Strength 600MG
Dosage form TABLET
Route ORAL
Application ANDA075682
Applicant holder DR REDDYS LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 14, 2001

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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