Orange Book product

NIFEDIPINE 20MG

Orange Book ANDA 074045 · VELZEN PHARMA PVT LTD · Prescription

Key facts

Proprietary name NIFEDIPINE
Active ingredients NIFEDIPINE
Strength 20MG
Dosage form CAPSULE
Route ORAL
Application ANDA074045
Applicant holder VELZEN PHARMA PVT LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 30, 1992

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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