Orange Book product

NADOLOL 80MG

Orange Book ANDA 210955 · REGCON HOLDINGS LLC · Prescription

Key facts

Proprietary name NADOLOL
Active ingredients NADOLOL
Strength 80MG
Dosage form TABLET
Route ORAL
Application ANDA210955
Applicant holder REGCON HOLDINGS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 23, 2018

At a glance

  • 10–99 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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