APPLICATION
NDA012665
TYPE
NDA
ORIGINAL APPROVAL
1965-11-25
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VELBAN · ReferenceDiscontinued
VINBLASTINE SULFATE 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 13AP
2007-12-07Labeling · Supplement 36 · standardAP
2007-12-07Labeling · Supplement 34 · standardAP
2007-12-07Labeling · Supplement 26AP
2007-12-07Labeling · Supplement 40 · standardAP
2007-12-07Labeling · Supplement 37 · standardAP
2007-12-07Labeling · Supplement 17AP
2000-08-24Labeling · Supplement 39 · standardAP
1999-03-04Manufacturing (CMC) · Supplement 38 · priorityAP
1997-09-02Manufacturing (CMC) · Supplement 35 · priorityAP
1996-12-20Labeling · Supplement 31 · standardAP
1996-10-21Manufacturing (CMC) · Supplement 33 · priorityAP
1995-11-06Manufacturing (CMC) · Supplement 32 · priorityAP
1995-07-05Manufacturing (CMC) · Supplement 30 · priorityAP
1993-09-07Labeling · Supplement 29 · standardAP
1992-12-16Labeling · Supplement 28 · standardAP
1992-07-31Labeling · Supplement 27AP
1990-08-10Labeling · Supplement 24AP
1990-06-18Labeling · Supplement 25AP
1989-06-06Labeling · Supplement 23AP
1989-06-06Labeling · Supplement 22AP
1988-04-18Labeling · Supplement 21AP
1987-10-16Manufacturing (CMC) · Supplement 16 · priorityAP
1987-08-25Labeling · Supplement 20AP
1987-05-05Manufacturing (CMC) · Supplement 18 · priorityAP
1987-03-19Manufacturing (CMC) · Supplement 19 · priorityAP
1987-01-07Manufacturing (CMC) · Supplement 15 · priorityAP
1986-11-03Labeling · Supplement 11AP
1986-06-30Labeling · Supplement 14AP
1986-01-15Manufacturing (CMC) · Supplement 12 · priorityAP
1981-07-02Manufacturing (CMC) · Supplement 10 · priorityAP
1980-06-20Manufacturing (CMC) · Supplement 7 · priorityAP
1979-01-10Manufacturing (CMC) · Supplement 9 · priorityAP
1978-09-25Labeling · Supplement 8AP
1965-11-25Type 1 - New Molecular Entity · Original · priorityAP
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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