Orange Book product

TRIMETHOPRIM 100MG

Orange Book ANDA 091437 · NOVEL LABORATORIES INC · Prescription

Key facts

Proprietary name TRIMETHOPRIM
Active ingredients TRIMETHOPRIM
Strength 100MG
Dosage form TABLET
Route ORAL
Application ANDA091437
Applicant holder NOVEL LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 15, 2011

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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