APPLICATION
NDA016093
TYPE
NDA
ORIGINAL APPROVAL
1967-01-10
LATEST ACTION
2005-07-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EDECRIN · ReferencePrescription
ETHACRYNATE SODIUM EQ 50MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2005-07-20Manufacturing (CMC) · Supplement 45 · standardAP
2002-06-10Manufacturing (CMC) · Supplement 42 · standardAP
2001-07-19Manufacturing (CMC) · Supplement 41 · standardAP
2001-06-18Manufacturing (CMC) · Supplement 40 · standardAP
2001-02-14Manufacturing (CMC) · Supplement 39 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 37 · standardAP
1997-11-03Labeling · Supplement 36 · standardAP
1996-10-08Manufacturing (CMC) · Supplement 33 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 35 · standardAP
1995-03-24Labeling · Supplement 34 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 32 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 31 · standardAP
1986-12-08Manufacturing (CMC) · Supplement 30 · standardAP
1986-03-21Labeling · Supplement 29AP
1986-01-13Labeling · Supplement 28AP
1985-08-27Manufacturing (CMC) · Supplement 27 · standardAP
1985-05-13Labeling · Supplement 20AP
1984-10-11Manufacturing (CMC) · Supplement 26 · standardAP
1984-08-28Labeling · Supplement 25AP
1983-09-20Manufacturing (CMC) · Supplement 24 · standardAP
1983-05-19Manufacturing (CMC) · Supplement 23 · standardAP
1981-11-03Manufacturing (CMC) · Supplement 21 · standardAP
1981-08-28Manufacturing (CMC) · Supplement 19 · standardAP
1981-07-14Manufacturing (CMC) · Supplement 22 · standardAP
1981-02-19Manufacturing (CMC) · Supplement 17 · standardAP
1981-01-16Labeling · Supplement 18AP
1980-01-25Labeling · Supplement 16AP
1979-06-21Manufacturing (CMC) · Supplement 15 · standardAP
1978-08-28Manufacturing (CMC) · Supplement 11 · standardAP
1978-08-28Manufacturing (CMC) · Supplement 14 · standardAP
1978-03-10Labeling · Supplement 13AP
1976-01-29Manufacturing (CMC) · Supplement 12 · standardAP
1967-01-10Type 2 - New Active Ingredient · 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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