Orange Book product

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN 650MG;100MG

Orange Book ANDA 070146 · IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA · Discontinued

Key facts

Proprietary name PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Active ingredients ACETAMINOPHEN, PROPOXYPHENE NAPSYLATE
Strength 650MG;100MG
Dosage form TABLET
Route ORAL
Application ANDA070146
Applicant holder IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 2, 1985

At a glance

  • None 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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