APPLICATION
ANDA072168
TYPE
ANDA
ORIGINAL APPROVAL
1990-08-31
LATEST ACTION
2020-06-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CYTARABINEPrescription
CYTARABINE 20MG/ML · INJECTABLE · INJECTION
Approval history
2020-06-02Labeling · Supplement 30 · standardAP
2019-01-15Labeling · Supplement 28 · standardAP
2019-01-15Labeling · Supplement 29 · standardAP
2004-04-19Labeling · Supplement 19AP
2001-05-14Manufacturing (CMC) · Supplement 16AP
2000-08-08Manufacturing (CMC) · Supplement 14AP
2000-05-18Manufacturing (CMC) · Supplement 13AP
2000-05-12Manufacturing (CMC) · Supplement 12AP
1997-06-02Labeling · Supplement 9AP
1997-04-16Manufacturing (CMC) · Supplement 8AP
1995-04-28Manufacturing (CMC) · Supplement 7AP
1994-09-23Labeling · Supplement 5AP
1994-05-23Manufacturing (CMC) · Supplement 6AP
1993-02-25Manufacturing (CMC) · Supplement 1AP
1991-04-22Manufacturing (CMC) · Supplement 2AP
1991-04-22Manufacturing (CMC) · Supplement 3AP
1991-03-15Manufacturing (CMC) · Supplement 4AP
1990-08-31OriginalAP
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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