Orange Book product

PROMETHACON 50MG

Orange Book ANDA 084902 · POLYMEDICA INDUSTRIES INC · Discontinued

Key facts

Proprietary name PROMETHACON
Active ingredients PROMETHAZINE HYDROCHLORIDE
Strength 50MG
Dosage form SUPPOSITORY
Route RECTAL
Application ANDA084902
Applicant holder POLYMEDICA INDUSTRIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
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
  • 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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