APPLICATION
ANDA074245
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-31
LATEST ACTION
2001-03-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CYTARABINEPrescription
CYTARABINE 1GM/VIAL · INJECTABLE · INJECTION
CYTARABINEPrescription
CYTARABINE 2GM/VIAL · INJECTABLE · INJECTION
Approval history
2001-03-27Manufacturing (CMC) · Supplement 3AP
2000-10-13Labeling · Supplement 4AP
1999-03-23Manufacturing (CMC) · Supplement 2AP
1997-07-11Labeling · Supplement 1AP
1994-08-31OriginalAP
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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