← FDA DRUG APPROVALS

FDA NDA · NDA020405

LANOXIN

digoxin

Sponsor: ADVANZ PHARMA

APPLICATION
NDA020405
TYPE
NDA
ORIGINAL APPROVAL
1997-09-30
LATEST ACTION
2024-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

LANOXIN · ReferenceDiscontinued
DIGOXIN 0.1875MG · TABLET · ORAL
LANOXIN · ReferencePrescription
DIGOXIN 0.0625MG · TABLET · ORAL
LANOXINDiscontinued
DIGOXIN 0.5MG · TABLET · ORAL
LANOXIN · ReferencePrescription
DIGOXIN 0.25MG · TABLET · ORAL
LANOXIN · ReferencePrescription
DIGOXIN 0.125MG · TABLET · ORAL
LANOXINDiscontinued
DIGOXIN 0.375MG · TABLET · ORAL

Approval history

2024-04-29Labeling · Supplement 17 · standard — Letter ↗AP
2019-02-22Labeling · Supplement 15 · standard — Label ↗AP
2018-08-24Labeling · Supplement 14 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 13 · standard — Label ↗AP
2015-09-03Manufacturing (CMC) · Supplement 12 · standardAP
2015-07-28Labeling · Supplement 11 · standard — Label ↗AP
2013-11-22Manufacturing (CMC) · Supplement 10 · standardAP
2013-10-17Labeling · Supplement 7 · standard — Label ↗AP
2013-05-21Manufacturing (CMC) · Supplement 9 · standardAP
2012-08-13Labeling · Supplement 5 · unknown — Letter ↗AP
2011-11-14Labeling · Supplement 6 · unknown — Letter ↗AP
2010-02-05Labeling · Supplement 4 · unknown — Letter ↗AP
2000-12-07Manufacturing (CMC) · Supplement 2 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-30Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗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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