APPLICATION
ANDA205672
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-31
LATEST ACTION
2021-05-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUSULFANPrescription
BUSULFAN 6MG/ML · INJECTABLE · INJECTION
Approval history
2021-05-21Labeling · Supplement 3 · standardAP
2021-05-21Labeling · Supplement 4 · standardAP
2018-07-31UNKNOWN · Original · standardAP
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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