APPLICATION
ANDA070119
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-06
LATEST ACTION
1998-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRETYLIUM TOSYLATEDiscontinued
BRETYLIUM TOSYLATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1998-01-14Manufacturing (CMC) · Supplement 14AP
1995-09-19Manufacturing (CMC) · Supplement 17AP
1994-11-08Labeling · Supplement 16AP
1994-06-17Manufacturing (CMC) · Supplement 15AP
1993-10-29Manufacturing (CMC) · Supplement 12AP
1993-09-30Labeling · Supplement 13AP
1992-07-31Manufacturing (CMC) · Supplement 7AP
1992-07-31Manufacturing (CMC) · Supplement 8AP
1992-02-18Labeling · Supplement 9AP
1991-04-19Manufacturing (CMC) · Supplement 5AP
1991-04-19Manufacturing (CMC) · Supplement 6AP
1987-05-06Manufacturing (CMC) · Supplement 1AP
1986-03-06OriginalAP
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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