Orange Book product

NISOLDIPINE 34MG

Orange Book ANDA 091001 · MYLAN PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name NISOLDIPINE
Active ingredients NISOLDIPINE
Strength 34MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA091001
Applicant holder MYLAN PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 26, 2011

At a glance

  • None 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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