Orange Book product

ACETAMINOPHEN 650MG

Orange Book ANDA 070608 · PERRIGO NEW YORK INC · Over the counter

Key facts

Proprietary name ACETAMINOPHEN
Active ingredients ACETAMINOPHEN
Strength 650MG
Dosage form SUPPOSITORY
Route RECTAL
Application ANDA070608
Applicant holder PERRIGO NEW YORK INC
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 1, 1986

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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