Orange Book product

IBUPROFEN 300MG

Orange Book ANDA 070328 · PAR PHARMACEUTICAL INC · Discontinued

Key facts

Proprietary name IBUPROFEN
Active ingredients IBUPROFEN
Strength 300MG
Dosage form TABLET
Route ORAL
Application ANDA070328
Applicant holder PAR PHARMACEUTICAL INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 6, 1985

At a glance

  • 1–9 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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