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FDA NDA · NDA018902

FUROSEMIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA018902
TYPE
NDA
ORIGINAL APPROVAL
1984-05-22
LATEST ACTION
2024-10-01
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FUROSEMIDEPrescription
FUROSEMIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2024-10-01Labeling · Supplement 36 · standard — Letter ↗AP
2023-02-23Labeling · Supplement 35 · standard — Letter ↗AP
2022-04-12Labeling · Supplement 33 · standard — Letter ↗AP
2016-09-19Labeling · Supplement 28 · standard — Letter ↗AP
2016-03-08Labeling · Supplement 27 · standard — Letter ↗AP
2015-07-01Manufacturing (CMC) · Supplement 26 · standardAP
2012-03-27Labeling · Supplement 24AP
2001-01-02Manufacturing (CMC) · Supplement 16 · standardAP
1999-01-11Manufacturing (CMC) · Supplement 15 · standardAP
1997-10-15Labeling · Supplement 14AP
1997-08-08Labeling · Supplement 13AP
1997-04-22Labeling · Supplement 12AP
1995-08-10Labeling · Supplement 11AP
1995-08-10Manufacturing (CMC) · Supplement 10 · standardAP
1995-04-18Manufacturing (CMC) · Supplement 7 · standardAP
1990-02-16Labeling · Supplement 8AP
1990-01-11Labeling · Supplement 6AP
1988-08-10Manufacturing (CMC) · Supplement 4 · standardAP
1986-07-16Manufacturing (CMC) · Supplement 2 · standardAP
1985-11-05Manufacturing (CMC) · Supplement 1 · standardAP
1984-05-22Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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