Orange Book product

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE EQ 25MG BASE;10MG

Orange Book ANDA 070478 · USL PHARMA INC · Discontinued

Key facts

Proprietary name CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Active ingredients AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE
Strength EQ 25MG BASE;10MG
Dosage form TABLET
Route ORAL
Application ANDA070478
Applicant holder USL PHARMA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 12, 1988

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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