Orange Book product

IBUPROHM 400MG

Orange Book ANDA 070469 · OHM LABORATORIES INC. · Discontinued

Key facts

Proprietary name IBUPROHM
Active ingredients IBUPROFEN
Strength 400MG
Dosage form TABLET
Route ORAL
Application ANDA070469
Applicant holder OHM LABORATORIES INC.
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 29, 1985

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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