← FDA DRUG APPROVALS

FDA NDA · NDA205832

OFEV

nintedanib

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA205832
TYPE
NDA
ORIGINAL APPROVAL
2014-10-15
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

OFEV · ReferencePrescription
NINTEDANIB ESYLATE EQ 150MG BASE · CAPSULE · ORAL
OFEV · ReferencePrescription
NINTEDANIB ESYLATE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2024-10-11Labeling · Supplement 28 · standard — Label ↗AP
2024-06-18Labeling · Supplement 27 · standard — Letter ↗AP
2022-01-13Labeling · Supplement 16 · standard — Letter ↗AP
2020-10-28Labeling · Supplement 14 · standard — Label ↗AP
2020-03-09Efficacy · Supplement 13 · priority — Label ↗AP
2019-09-06Efficacy · Supplement 12 · priority — Letter ↗AP
2018-11-09Labeling · Supplement 10 · standard — Label ↗AP
2018-01-29Labeling · Supplement 9 · standard — Label ↗AP
2017-12-13Labeling · Supplement 7 · standard — Label ↗AP
2017-08-04Labeling · Supplement 5 · standard — Label ↗AP
2017-02-09Labeling · Supplement 4 · standard — Label ↗AP
2016-06-16Manufacturing (CMC) · Supplement 2 · priorityAP
2016-02-04Labeling · Supplement 1 · standard — Letter ↗AP
2014-10-15Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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