Drug application

NINTEDANIB ESYLATE (NINTEDANIB ESYLATE)

Drugs@FDA ANDA 219283 · DR REDDYS

Key facts

Drug name NINTEDANIB ESYLATE
Active ingredients NINTEDANIB ESYLATE
Application type ANDA
Application number 219283
Company DR REDDYS
Dosage forms CAPSULE, ORAL
Strength EQ 100MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Apr 2, 2026

At a glance

  • 1–9 Submissions
  • 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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