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Nintedanib · Regulatory approval
U.S. Food and Drug Administration · April 2, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a regulatory approval record documenting FDA authorization of a generic nintedanib formulation (100 mg and 150 mg capsules) from Dr Reddy's Laboratories on 2 April 2026. The record does not contain clinical trial results, efficacy data, or safety outcomes; it confirms only that the application met regulatory requirements for approval.
Regulatory approval.
This is a regulatory approval record documenting FDA authorization of a generic nintedanib formulation (100 mg and 150 mg capsules) from Dr Reddy's Laboratories on 2 April 2026. The record does not contain clinical trial results, efficacy data, or safety outcomes; it confirms only that the application met regulatory requirements for approval.
This record does not contain clinical trial data, efficacy results, or safety outcomes.
The source did not state who this applies to in practice.
FDA approval of a generic nintedanib formulation; establishes regulatory authorization but does not contain clinical efficacy or safety data.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA219283. This is a regulatory action record, not a clinical study. Brand name: NINTEDANIB. Active ingredient: NINTEDANIB. Sponsor: DR REDDYS. Submission type: ORIG (original application). Approval status date: 2026-04-02. Products: NINTEDANIB ESYLATE, CAPSULE, ORAL, NINTEDANIB ESYLATE EQ 100MG BASE; NINTEDANIB ESYLATE, CAPSULE, ORAL, NINTEDANIB ESYLATE EQ 150MG BASE.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.