Drug application

RIMEGEPANT (RIMEGEPANT)

Drugs@FDA ANDA 219399 · APOTEX CORP

Key facts

Drug name RIMEGEPANT
Active ingredients RIMEGEPANT
Application type ANDA
Application number 219399
Company APOTEX CORP
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength 75MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Dec 31, 2025

At a glance

  • 1–9 Submissions
  • 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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