Orange Book product

TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;30MG/5ML;1.25MG/5ML

Orange Book ANDA 088833 · WOCKHARDT EU OPERATIONS (SWISS) AG · Discontinued

Key facts

Proprietary name TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Active ingredients CODEINE PHOSPHATE, PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Strength 10MG/5ML;30MG/5ML;1.25MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA088833
Applicant holder WOCKHARDT EU OPERATIONS (SWISS) AG
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 16, 1984

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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