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Medicines · US (FDA)
Kinase inhibitors

FDA 2026

Other protein kinase inhibitors

Nintedanib Esylate

Approved 2 Apr 2026OralCapsule

The FDA lists this product in 10 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: NINTEDANIB ESYLATE EQ 100MG BASE

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

NINTEDANIB ESYLATE EQ 100MG BASE · CapsuleThis page
NINTEDANIB ESYLATE EQ 150MG BASE · CapsuleANDA219283-002 · Prescription
NINTEDANIB ESYLATE EQ 150MG BASE · CapsuleANDA216915-002 · Prescription
NINTEDANIB ESYLATE EQ 100MG BASE · CapsuleANDA216915-001 · Prescription
NINTEDANIB ESYLATE EQ 100MG BASE · CapsuleANDA219819-001 · Prescription
NINTEDANIB ESYLATE EQ 150MG BASE · CapsuleANDA219819-002 · Prescription
NINTEDANIB ESYLATE EQ 100MG BASE · CapsuleANDA212609-001 · Prescription
NINTEDANIB ESYLATE EQ 150MG BASE · CapsuleANDA212609-002 · Prescription
NINTEDANIB ESYLATE EQ 150MG BASE · CapsuleANDA219227-002 · Prescription
NINTEDANIB ESYLATE EQ 100MG BASE · CapsuleANDA219227-001 · Prescription

More in kinase inhibitors

Jakafi XRruxolitinib phosphate · Tablet, extended release
NintedanibCapsule

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA219283.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Nintedanib Esylate
Drug class: Other protein kinase inhibitors
Group: Kinase inhibitors
Route: Oral
Dosage form: Capsule
Applicant: DR Reddys
Status: Prescription
FDA approval: 2 Apr 2026
Application: ANDA219283-001
RxCUI: 1592736

Guidelines

Guidelines in oncology1,852 guidelines in the library

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