Orange Book product

TRIMETHOPRIM 100MG

Orange Book NDA 018679 · DR REDDYS LABORATORIES SA · Prescription

Key facts

Proprietary name TRIMETHOPRIM
Active ingredients TRIMETHOPRIM
Strength 100MG
Dosage form TABLET
Route ORAL
Application NDA018679
Applicant holder DR REDDYS LABORATORIES SA
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jul 30, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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