APPLICATION
ANDA089515
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-29
LATEST ACTION
2021-10-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VINBLASTINE SULFATEPrescription
VINBLASTINE SULFATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2021-10-25Manufacturing (CMC) · Supplement 38 · unknownAP
2003-11-20Labeling · Supplement 26AP
2002-12-05Manufacturing (CMC) · Supplement 25AP
2001-11-05Labeling · Supplement 24AP
1997-07-02Labeling · Supplement 21AP
1996-10-18Manufacturing (CMC) · Supplement 20AP
1994-10-21Labeling · Supplement 19AP
1993-01-13Labeling · Supplement 18AP
1992-12-17Labeling · Supplement 17AP
1992-02-28Labeling · Supplement 16AP
1991-01-29Labeling · Supplement 12AP
1987-09-30Manufacturing (CMC) · Supplement 9AP
1987-09-30Manufacturing (CMC) · Supplement 10AP
1987-09-30Manufacturing (CMC) · Supplement 11AP
1987-08-12Manufacturing (CMC) · Supplement 1AP
1987-08-12Manufacturing (CMC) · Supplement 2AP
1987-04-29OriginalAP
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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