Orange Book product

DULOXETINE HYDROCHLORIDE EQ 30MG BASE

Orange Book ANDA 210599 · QINGDAO BAHEAL PHARMACEUTICAL CO LTD · Prescription

Key facts

Proprietary name DULOXETINE HYDROCHLORIDE
Active ingredients DULOXETINE HYDROCHLORIDE
Strength EQ 30MG BASE
Dosage form CAPSULE, DELAYED REL PELLETS
Route ORAL
Application ANDA210599
Applicant holder QINGDAO BAHEAL PHARMACEUTICAL CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 17, 2019

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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