APPLICATION
ANDA070891
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-26
LATEST ACTION
2001-04-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRETYLIUM TOSYLATEDiscontinued
BRETYLIUM TOSYLATE 50MG/ML · INJECTABLE · INJECTION
Approval history
2001-04-23Manufacturing (CMC) · Supplement 10AP
2001-04-23Manufacturing (CMC) · Supplement 9AP
2000-04-12Labeling · Supplement 8AP
1998-12-17Manufacturing (CMC) · Supplement 7AP
1997-04-25Manufacturing (CMC) · Supplement 6AP
1997-01-29Manufacturing (CMC) · Supplement 5AP
1996-02-28Manufacturing (CMC) · Supplement 4AP
1994-11-08Labeling · Supplement 3AP
1994-07-14Manufacturing (CMC) · Supplement 2AP
1991-03-12Labeling · Supplement 1AP
1988-07-26OriginalAP
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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