Orange Book product

ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG

Orange Book ANDA 040443 · WATSON LABORATORIES INC FLORIDA · Discontinued

Key facts

Proprietary name ACETAMINOPHEN AND CODEINE PHOSPHATE
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Strength 300MG;15MG
Dosage form TABLET
Route ORAL
Application ANDA040443
Applicant holder WATSON LABORATORIES INC FLORIDA
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 22, 2003

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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