Nintedanib Esylate

Treats idiopathic pulmonary fibrosis (IPF). ANDA 219926, held by Macleods Pharms. Nintedanib Esylate.

As of Nov 15, 2026, ANDA 219926 (Nintedanib Esylate), held by Macleods Pharms, was first approved by FDA on Aug 3, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Nintedanib capsules are kinase inhibitor indicated in adults for:

Treatment of idiopathic pulmonary fibrosis (IPF)
Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsules are indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsules are indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Aug 3, 2026	Original application	Approved	None posted

Products

2 strengths and forms


Nintedanib EsylateEQ 100MG BASE · capsule;oral	Nintedanib Esylate	Rx
Nintedanib EsylateEQ 150MG BASE · capsule;oral	Nintedanib Esylate	Rx

Identifiers

Application: ANDA 219926
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters