Orange Book product

PAPA-DEINE #4 300MG;60MG

Orange Book ANDA 088715 · VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO · Discontinued

Key facts

Proprietary name PAPA-DEINE #4
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Strength 300MG;60MG
Dosage form TABLET
Route ORAL
Application ANDA088715
Applicant holder VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 20, 1984

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)

Browse all Orange Book products