APPLICATION
ANDA075383
TYPE
ANDA
ORIGINAL APPROVAL
1999-11-22
LATEST ACTION
2020-06-02
ROUTE
INTRATHECAL, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CYTARABINEPrescription
CYTARABINE 100MG/ML · INJECTABLE · INJECTION
Approval history
2020-06-02Labeling · Supplement 18 · standardAP
2019-01-15Labeling · Supplement 17 · standardAP
2018-10-03Labeling · Supplement 15 · standardAP
2001-05-14Manufacturing (CMC) · Supplement 4AP
2000-11-28Manufacturing (CMC) · Supplement 2AP
2000-10-17Manufacturing (CMC) · Supplement 1AP
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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