Drug application

NINTEDANIB (NINTEDANIB)

Drugs@FDA ANDA 215123 · EUGIA PHARMA SPECLTS

Key facts

Drug name NINTEDANIB
Active ingredients NINTEDANIB
Application type ANDA
Application number 215123
Company EUGIA PHARMA SPECLTS
Dosage forms CAPSULE, ORAL
Strength EQ 150MG BASE
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Feb 4, 2026

At a glance

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