APPLICATION
NDA016092
TYPE
NDA
ORIGINAL APPROVAL
1967-01-10
LATEST ACTION
2015-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
EDECRIN · ReferencePrescription
ETHACRYNIC ACID 25MG · TABLET · ORAL
EDECRINDiscontinued
ETHACRYNIC ACID 50MG · TABLET · ORAL
Approval history
2015-03-30Manufacturing (CMC) · Supplement 46 · standardAP
1998-08-14Manufacturing (CMC) · Supplement 38 · standardAP
1997-11-03Labeling · Supplement 36 · standardAP
1996-06-24Manufacturing (CMC) · Supplement 35 · standardAP
1995-03-24Labeling · Supplement 34 · standardAP
1994-09-26Manufacturing (CMC) · Supplement 33 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 32 · standardAP
1988-09-06Manufacturing (CMC) · Supplement 31 · standardAP
1988-08-15Manufacturing (CMC) · Supplement 30 · standardAP
1986-03-21Labeling · Supplement 29AP
1986-01-13Labeling · Supplement 28AP
1985-05-13Labeling · Supplement 23AP
1984-08-28Labeling · Supplement 27AP
1983-09-20Manufacturing (CMC) · Supplement 26 · standardAP
1983-05-19Manufacturing (CMC) · Supplement 25 · standardAP
1981-09-04Manufacturing (CMC) · Supplement 22 · standardAP
1981-06-17Manufacturing (CMC) · Supplement 24 · standardAP
1981-02-19Manufacturing (CMC) · Supplement 20 · standardAP
1981-01-22Manufacturing (CMC) · Supplement 18 · standardAP
1981-01-16Labeling · Supplement 21AP
1980-11-14Manufacturing (CMC) · Supplement 19 · standardAP
1980-01-25Labeling · Supplement 17AP
1979-11-29Labeling · Supplement 16AP
1979-06-21Manufacturing (CMC) · Supplement 15 · standardAP
1979-03-09Manufacturing (CMC) · Supplement 14 · standardAP
1978-02-22Manufacturing (CMC) · Supplement 12 · standardAP
1977-03-21Manufacturing (CMC) · Supplement 11 · standardAP
1976-02-09Manufacturing (CMC) · Supplement 10 · standardAP
1967-01-10Type 1 - New Molecular Entity · Original · standardAP
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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