Treats idiopathic pulmonary fibrosis (IPF). ANDA 212609, held by Cipla. Nintedanib Esylate.
As of Nov 15, 2026, ANDA 212609 (Nintedanib Esylate), held by Cipla, was first approved by FDA on Apr 2, 2026, with 0 approved supplements and 0 published complete response letters.
Nintedanib is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF). Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsule is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsule is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2026 | Original application | Approved |
| Nintedanib EsylateEQ 100MG BASE · capsule;oral | Nintedanib Esylate | Rx |
| Nintedanib EsylateEQ 150MG BASE · capsule;oral | Nintedanib Esylate | Rx |
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
