Orange Book product

NIMODIPINE 30MG

Orange Book ANDA 076740 · BIONPHARMA INC · Prescription

Key facts

Proprietary name NIMODIPINE
Active ingredients NIMODIPINE
Strength 30MG
Dosage form CAPSULE
Route ORAL
Application ANDA076740
Applicant holder BIONPHARMA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 17, 2008

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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