Orange Book product

PHRENILIN WITH CAFFEINE AND CODEINE 325MG;50MG;40MG;30MG

Orange Book ANDA 074911 · VALEANT PHARMACEUTICALS INTERNATIONAL · Discontinued

Key facts

Proprietary name PHRENILIN WITH CAFFEINE AND CODEINE
Active ingredients ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE
Strength 325MG;50MG;40MG;30MG
Dosage form CAPSULE
Route ORAL
Application ANDA074911
Applicant holder VALEANT PHARMACEUTICALS INTERNATIONAL
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 22, 2001

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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