Orange Book product

SULAR 25.5MG **Federal Register determination that product was not…

Orange Book NDA 020356 · AZURITY PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name SULAR
Active ingredients NISOLDIPINE
Strength 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application NDA020356
Applicant holder AZURITY PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 2, 2008

At a glance

  • None 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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