Orange Book product

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE 10MG/5ML;30MG/5ML;1.25MG/5ML

Orange Book ANDA 089018 · HR CENCI LABORATORIES INC · Discontinued

Key facts

Proprietary name TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
Active ingredients CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Strength 10MG/5ML;30MG/5ML;1.25MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA089018
Applicant holder HR CENCI LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 23, 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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