Orange Book product

DICYCLOMINE HYDROCHLORIDE 10MG

Orange Book ANDA 040204 · WEST WARD PHARMACEUTICAL CORP · Prescription

Key facts

Proprietary name DICYCLOMINE HYDROCHLORIDE
Active ingredients DICYCLOMINE HYDROCHLORIDE
Strength 10MG
Dosage form CAPSULE
Route ORAL
Application ANDA040204
Applicant holder WEST WARD PHARMACEUTICAL CORP
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 28, 1997

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)

Browse all Orange Book products