APPLICATION
ANDA075812
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-15
LATEST ACTION
2002-10-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DACARBAZINEPrescription
DACARBAZINE 500MG/VIAL · INJECTABLE · INJECTION
DACARBAZINEPrescription
DACARBAZINE 200MG/VIAL · INJECTABLE · INJECTION
Approval history
2002-10-31Labeling · Supplement 2AP
2002-10-31Manufacturing (CMC) · Supplement 3AP
2002-10-31Manufacturing (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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