Orange Book product

ORPHENADRINE CITRATE 100MG

Orange Book ANDA 040368 · JEROME STEVENS PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name ORPHENADRINE CITRATE
Active ingredients ORPHENADRINE CITRATE
Strength 100MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA040368
Applicant holder JEROME STEVENS PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 23, 2000

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)

Browse all Orange Book products