APPLICATION
NDA014103
TYPE
NDA
ORIGINAL APPROVAL
1963-07-10
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONCOVIN · ReferenceDiscontinued
VINCRISTINE SULFATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ONCOVIN · ReferenceDiscontinued
VINCRISTINE SULFATE 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ONCOVIN · ReferenceDiscontinued
VINCRISTINE SULFATE 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 57 · standardAP
2007-12-07Labeling · Supplement 63 · standardAP
2007-12-07Labeling · Supplement 61 · standardAP
2007-12-07Labeling · Supplement 45AP
2007-12-07Labeling · Supplement 41AP
2007-12-07Labeling · Supplement 19AP
2007-12-07Labeling · Supplement 25AP
2007-12-07Labeling · Supplement 56 · standardAP
2007-12-07Labeling · Supplement 54 · standardAP
2007-12-07Labeling · Supplement 28AP
2007-12-07Labeling · Supplement 34AP
2007-12-07Efficacy · Supplement 32AP
2001-01-02Manufacturing (CMC) · Supplement 62 · priorityAP
1999-08-26Labeling · Supplement 60 · standardAP
1998-04-29Manufacturing (CMC) · Supplement 59 · priorityAP
1997-10-03Manufacturing (CMC) · Supplement 58 · priorityAP
1996-03-28Manufacturing (CMC) · Supplement 53 · priorityAP
1995-11-06Manufacturing (CMC) · Supplement 55 · priorityAP
1995-07-05Manufacturing (CMC) · Supplement 52 · priorityAP
1992-12-16Labeling · Supplement 51 · standardAP
1992-06-30Labeling · Supplement 50AP
1992-04-02Labeling · Supplement 49AP
1991-04-23Manufacturing (CMC) · Supplement 47 · priorityAP
1991-01-02Manufacturing (CMC) · Supplement 48 · priorityAP
1990-06-14Labeling · Supplement 46AP
1989-06-06Labeling · Supplement 44AP
1988-09-16Labeling · Supplement 43AP
1988-06-22Manufacturing (CMC) · Supplement 42 · priorityAP
1988-04-05Labeling · Supplement 40AP
1987-08-17Labeling · Supplement 39AP
1987-07-23Manufacturing (CMC) · Supplement 38 · priorityAP
1987-02-19Manufacturing (CMC) · Supplement 37 · priorityAP
1986-03-17Labeling · Supplement 35AP
1986-01-27Labeling · Supplement 36AP
1985-09-23Labeling · Supplement 31AP
1985-08-16Manufacturing (CMC) · Supplement 33 · priorityAP
1985-05-31Manufacturing (CMC) · Supplement 27 · priorityAP
1984-03-07Labeling · Supplement 30AP
1983-09-20Manufacturing (CMC) · Supplement 29 · priorityAP
1982-12-09Efficacy · Supplement 24AP
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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