ANDA 220118, held by Biocon Pharma. Nintedanib Esylate.
As of Nov 15, 2026, ANDA 220118 (Nintedanib Esylate), held by Biocon Pharma, was first approved by FDA on Aug 19, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2026 | Original application | Approved | None posted |
| 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
