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FDA NDA · NDA021648

DIGOXIN

Sponsor: HIKMA

APPLICATION
NDA021648
TYPE
NDA
ORIGINAL APPROVAL
2004-08-26
LATEST ACTION
2025-04-14
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Prescription

Products

DIGOXIN · ReferencePrescription
DIGOXIN 0.05MG/ML · ELIXIR · ORAL

Approval history

2025-04-14Labeling · Supplement 13 · standard — Letter ↗AP
2024-04-25Labeling · Supplement 15 · standard — Letter ↗AP
2018-08-24Labeling · Supplement 11 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 9 · standard — Label ↗AP
2015-07-28Labeling · Supplement 8 · standard — Label ↗AP
2014-07-03Manufacturing (CMC) · Supplement 7 · standardAP
2012-09-27Labeling · Supplement 6 · unknown — Letter ↗AP
2011-11-18Labeling · Supplement 5 · unknown — Letter ↗AP
2011-09-26Labeling · Supplement 4 · standard — Label ↗AP
2004-08-26Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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