APPLICATION
NDA019033
TYPE
NDA
ORIGINAL APPROVAL
1986-04-16
LATEST ACTION
2001-06-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRETYLIUM TOSYLATEDiscontinued
BRETYLIUM TOSYLATE 50MG/ML · INJECTABLE · INJECTION
Approval history
2001-06-28Manufacturing (CMC) · Supplement 8 · standardAP
1999-08-26Labeling · Supplement 6 · standardAP
1998-10-15Manufacturing (CMC) · Supplement 7 · standardAP
1996-08-07Manufacturing (CMC) · Supplement 5 · standardAP
1994-03-04Labeling · Supplement 3 · standardAP
1990-08-20Manufacturing (CMC) · Supplement 2 · standardAP
1988-11-22Manufacturing (CMC) · Supplement 1 · standardAP
1986-04-16Type 5 - New Formulation or New Manufacturer · 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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