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FDA NDA · NDA018415

FUROSEMIDE

Sponsor: ESJAY PHARMA

APPLICATION
NDA018415
TYPE
NDA
ORIGINAL APPROVAL
1982-07-27
LATEST ACTION
2022-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FUROSEMIDEPrescription
FUROSEMIDE 80MG · TABLET · ORAL
FUROSEMIDEPrescription
FUROSEMIDE 20MG · TABLET · ORAL
FUROSEMIDEPrescription
FUROSEMIDE 40MG · TABLET · ORAL

Approval history

2022-09-16Labeling · Supplement 28 · standard — Letter ↗AP
2014-10-01Labeling · Supplement 26 · standard — Letter ↗AP
1999-06-08Manufacturing (CMC) · Supplement 24AP
1995-11-14Manufacturing (CMC) · Supplement 23AP
1993-06-30Manufacturing (CMC) · Supplement 21AP
1993-04-01Labeling · Supplement 22AP
1992-03-26Labeling · Supplement 20AP
1989-08-09Manufacturing (CMC) · Supplement 19AP
1989-08-09Manufacturing (CMC) · Supplement 18AP
1988-11-04Manufacturing (CMC) · Supplement 14AP
1988-11-04Manufacturing (CMC) · Supplement 12AP
1988-11-04Manufacturing (CMC) · Supplement 17AP
1988-11-04Labeling · Supplement 15AP
1988-11-04Manufacturing (CMC) · Supplement 13AP
1987-03-17Manufacturing (CMC) · Supplement 8AP
1986-11-06Manufacturing (CMC) · Supplement 9AP
1986-11-06Manufacturing (CMC) · Supplement 11AP
1982-07-27OriginalAP
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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