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FDA NDA · NDA019008
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: HOSPIRA INC
APPLICATION
NDA019008
TYPE
NDA
ORIGINAL APPROVAL
1986-04-16
LATEST ACTION
2001-06-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
BRETYLIUM TOSYLATE 400MG/100ML · INJECTABLE · INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
BRETYLIUM TOSYLATE 800MG/100ML · INJECTABLE · INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
BRETYLIUM TOSYLATE 200MG/100ML · INJECTABLE · INJECTION
Approval history
2001-06-29Manufacturing (CMC) · Supplement 21 · standardAP
1999-04-16Labeling · Supplement 19 · standardAP
1998-11-05Manufacturing (CMC) · Supplement 20 · standardAP
1997-06-12Manufacturing (CMC) · Supplement 18 · standardAP
1997-03-18Manufacturing (CMC) · Supplement 17 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 14 · standardAP
1996-02-02Manufacturing (CMC) · Supplement 16 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 15 · standardAP
1994-03-04Labeling · Supplement 12 · standardAP
1991-12-31Manufacturing (CMC) · Supplement 10 · standardAP
1991-07-18Manufacturing (CMC) · Supplement 11 · standardAP
1990-03-23Manufacturing (CMC) · Supplement 8 · standardAP
1990-03-20Manufacturing (CMC) · Supplement 9 · standardAP
1988-11-22Manufacturing (CMC) · Supplement 7 · standardAP
1987-09-16Manufacturing (CMC) · Supplement 6 · standardAP
1987-08-26Manufacturing (CMC) · Supplement 5 · standardAP
1987-03-13Manufacturing (CMC) · Supplement 3 · standardAP
1986-10-29Manufacturing (CMC) · Supplement 4 · standardAP
1986-09-24Manufacturing (CMC) · Supplement 1 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 2 · standardAP
1986-04-16Type 3 - New Dosage Form · 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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