APPLICATION
ANDA208536
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-20
LATEST ACTION
2019-08-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUSULFANDiscontinued
BUSULFAN 6MG/ML · INJECTABLE · INJECTION
Approval history
2019-08-12Labeling · Supplement 2 · standardAP
2019-08-12Labeling · Supplement 1 · standardAP
2017-11-20UNKNOWN · 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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