Orange Book product

TYLENOL W/ CODEINE NO. 2 300MG;15MG

Orange Book ANDA 085055 · JANSSEN PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name TYLENOL W/ CODEINE NO. 2
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Strength 300MG;15MG
Dosage form TABLET
Route ORAL
Application ANDA085055
Applicant holder JANSSEN PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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