Orange Book product

DOPAMINE HYDROCHLORIDE 40MG/ML

Orange Book ANDA 207707 · HIKMA INTERNATIONAL PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name DOPAMINE HYDROCHLORIDE
Active ingredients DOPAMINE HYDROCHLORIDE
Strength 40MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA207707
Applicant holder HIKMA INTERNATIONAL PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 11, 2018

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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