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General MedicationsORALStandard

NINTEDANIB ESYLATE

NINTEDANIB ESYLATE

Standard Dose
EQ 150MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NINTEDANIB ESYLATE is listed in Drugs@FDA under application 219819 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NINTEDANIB ESYLATE Form and strength CAPSULE;ORAL - EQ 150MG BASE Sponsor DEXCEL Submission history Latest submission status date: 2026-04-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview NINTEDANIB ESYLATE is listed in Drugs@FDA under application 219819 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NINTEDANIB ESYLATE Form and strength CAPSULE;ORAL - EQ 150MG BASE Sponsor DEXCEL Submission history Latest submission status date: 2026-04-02 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.