Drug application

PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)

Drugs@FDA ANDA 206156 · MACLEODS PHARMS

Key facts

Drug name PRAMIPEXOLE DIHYDROCHLORIDE
Active ingredients PRAMIPEXOLE DIHYDROCHLORIDE
Application type ANDA
Application number 206156
Company MACLEODS PHARMS
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 0.375MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jan 23, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

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

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