Drug application

PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)

Drugs@FDA ANDA 077724 · HERITAGE PHARMA AVET

Key facts

Drug name PRAMIPEXOLE DIHYDROCHLORIDE
Active ingredients PRAMIPEXOLE DIHYDROCHLORIDE
Application type ANDA
Application number 077724
Company HERITAGE PHARMA AVET
Dosage forms TABLET, ORAL
Strength 0.125MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Feb 19, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None 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:

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