Orange Book product

NIFEDIPINE 30MG

Orange Book ANDA 075108 · PHARMOBEDIENT CONSULTING LLC · Discontinued

Key facts

Proprietary name NIFEDIPINE
Active ingredients NIFEDIPINE
Strength 30MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA075108
Applicant holder PHARMOBEDIENT CONSULTING LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 17, 1999

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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