← FDA DRUG APPROVALS

FDA NDA · NDA009330

LANOXIN

digoxin

Sponsor: AZURITY

APPLICATION
NDA009330
TYPE
NDA
ORIGINAL APPROVAL
1954-11-16
LATEST ACTION
2025-10-09
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LANOXIN PEDIATRIC · ReferencePrescription
DIGOXIN 0.1MG/ML · INJECTABLE · INJECTION
LANOXIN · ReferencePrescription
DIGOXIN 0.25MG/ML · INJECTABLE · INJECTION

Approval history

2025-10-09Labeling · Supplement 40 · standard — Label ↗AP
2024-06-20Labeling · Supplement 39 · standard — Label ↗AP
2022-11-02Labeling · Supplement 36 · standard — Letter ↗AP
2018-09-20Labeling · Supplement 33 · standard — Letter ↗AP
2018-08-24Labeling · Supplement 34 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 31 · standard — Label ↗AP
2015-07-28Labeling · Supplement 30 · standard — Letter ↗AP
2013-05-16Labeling · Supplement 27 · unknown — Label ↗AP
2011-11-14Labeling · Supplement 26 · unknown — Label ↗AP
2010-02-05Labeling · Supplement 25 · unknown — Letter ↗AP
2002-06-17Manufacturing (CMC) · Supplement 21 — Letter ↗AP
1998-07-15Labeling · Supplement 20 · standard — Review ↗AP
1996-06-25Labeling · Supplement 18 · standardAP
1995-08-30Labeling · Supplement 17 · standardAP
1993-08-06Manufacturing (CMC) · Supplement 16AP
1992-05-07Labeling · Supplement 15AP
1991-09-06Manufacturing (CMC) · Supplement 14AP
1954-11-16Type 1 - New Molecular Entity · Original · priorityAP
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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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