APPLICATION
ANDA074284
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-10
LATEST ACTION
2002-10-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ETOPOSIDEDiscontinued
ETOPOSIDE 20MG/ML · INJECTABLE · INJECTION
Approval history
2002-10-11Labeling · Supplement 18AP
1999-02-23Manufacturing (CMC) · Supplement 17AP
1998-06-16Manufacturing (CMC) · Supplement 15AP
1998-06-16Manufacturing (CMC) · Supplement 13AP
1998-06-16Labeling · Supplement 16AP
1998-06-16Manufacturing (CMC) · Supplement 14AP
1997-06-20Manufacturing (CMC) · Supplement 11AP
1997-06-11Manufacturing (CMC) · Supplement 10AP
1997-04-22Labeling · Supplement 12AP
1996-09-27Labeling · Supplement 9AP
1996-04-25Labeling · Supplement 5AP
1996-04-25Manufacturing (CMC) · Supplement 6AP
1996-04-25Manufacturing (CMC) · Supplement 7AP
1995-08-23Labeling · Supplement 3AP
1995-08-23Manufacturing (CMC) · Supplement 2AP
1994-09-16Manufacturing (CMC) · Supplement 1AP
1994-09-16Labeling · Supplement 4AP
1994-02-10OriginalAP
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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