Orange Book product

PONSTEL 250MG

Orange Book NDA 015034 · AVION PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name PONSTEL
Active ingredients MEFENAMIC ACID
Strength 250MG
Dosage form CAPSULE
Route ORAL
Application NDA015034
Applicant holder AVION PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 1, 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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