Orange Book product

ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG

Orange Book ANDA 040223 · DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC · Discontinued

Key facts

Proprietary name ACETAMINOPHEN AND CODEINE PHOSPHATE
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Strength 300MG;30MG
Dosage form TABLET
Route ORAL
Application ANDA040223
Applicant holder DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 18, 1997

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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