Orange Book product

UROPLUS DS 800MG;160MG

Orange Book ANDA 071816 · SHIONOGI USA INC · Discontinued

Key facts

Proprietary name UROPLUS DS
Active ingredients SULFAMETHOXAZOLE, TRIMETHOPRIM
Strength 800MG;160MG
Dosage form TABLET
Route ORAL
Application ANDA071816
Applicant holder SHIONOGI USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 28, 1987

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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