Orange Book product

CHLORPROMAZINE HYDROCHLORIDE 30MG/ML

Orange Book ANDA 214542 · GENUS LIFESCIENCES INC · Prescription

Key facts

Proprietary name CHLORPROMAZINE HYDROCHLORIDE
Active ingredients CHLORPROMAZINE HYDROCHLORIDE
Strength 30MG/ML
Dosage form CONCENTRATE
Route ORAL
Application ANDA214542
Applicant holder GENUS LIFESCIENCES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jun 2, 2021

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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