Orange Book product

PHENAPHEN W/ CODEINE NO. 4 325MG;60MG

Orange Book ANDA 084446 · AH ROBINS CO · Discontinued

Key facts

Proprietary name PHENAPHEN W/ CODEINE NO. 4
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Strength 325MG;60MG
Dosage form CAPSULE
Route ORAL
Application ANDA084446
Applicant holder AH ROBINS CO
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • None 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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