Orange Book product

DOXEPIN HYDROCHLORIDE EQ 25MG BASE

Orange Book ANDA 207482 · AMNEAL PHARMACEUTICALS CO GMBH · Prescription

Key facts

Proprietary name DOXEPIN HYDROCHLORIDE
Active ingredients DOXEPIN HYDROCHLORIDE
Strength EQ 25MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA207482
Applicant holder AMNEAL PHARMACEUTICALS CO GMBH
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 28, 2017

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)

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