Drug application

APOMORPHINE HYDROCHLORIDE (APOMORPHINE HYDROCHLORIDE)

Drugs@FDA ANDA 212025 · TP ANDA HOLDINGS

Key facts

Drug name APOMORPHINE HYDROCHLORIDE
Active ingredients APOMORPHINE HYDROCHLORIDE
Application type ANDA
Application number 212025
Company TP ANDA HOLDINGS
Dosage forms INJECTABLE, SUBCUTANEOUS
Strength 30MG/3ML (10MG/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Feb 23, 2022

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

Browse all Drugs@FDA applications