Orange Book product

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE 356.4MG;30MG;16MG

Orange Book ANDA 040688 · WRASER PHARMACEUTICALS LLC · Discontinued

Key facts

Proprietary name ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
Active ingredients ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE
Strength 356.4MG;30MG;16MG
Dosage form CAPSULE
Route ORAL
Application ANDA040688
Applicant holder WRASER PHARMACEUTICALS LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 3, 2007

At a glance

  • None 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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