APPLICATION
NDA050577
TYPE
NDA
ORIGINAL APPROVAL
1982-05-07
LATEST ACTION
2016-11-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ZANOSAR · ReferenceDiscontinued
STREPTOZOCIN 1GM/VIAL · INJECTABLE · INJECTION
Approval history
2016-11-14Manufacturing (CMC) · Supplement 42 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 40 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 41 · standardAP
2014-09-23Manufacturing (CMC) · Supplement 39 · standardAP
2014-07-31Manufacturing (CMC) · Supplement 38 · standardAP
2013-08-09Manufacturing (CMC) · Supplement 36 · standardAP
2012-12-12Manufacturing (CMC) · Supplement 37 · standardAP
2012-12-04Manufacturing (CMC) · Supplement 34 · standardAP
2012-12-04Manufacturing (CMC) · Supplement 20 · standardAP
2012-12-04Manufacturing (CMC) · Supplement 35 · standardAP
2002-10-22Manufacturing (CMC) · Supplement 17 · standardAP
2000-04-03Manufacturing (CMC) · Supplement 15 · standardAP
1999-05-05Labeling · Supplement 13 · standardAP
1995-06-29Manufacturing (CMC) · Supplement 12 · standardAP
1994-09-27Manufacturing (CMC) · Supplement 11 · standardAP
1994-08-11Manufacturing (CMC) · Supplement 7 · standardAP
1993-06-14Manufacturing (CMC) · Supplement 10 · standardAP
1988-04-22Labeling · Supplement 6AP
1986-11-17Labeling · Supplement 5AP
1982-05-07Type 1 - New Molecular Entity · 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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