Orange Book product

NIACIN 1GM

Orange Book ANDA 207726 · MPP PHARMA LLC · Prescription

Key facts

Proprietary name NIACIN
Active ingredients NIACIN
Strength 1GM
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA207726
Applicant holder MPP PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 25, 2025

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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