APPLICATION
ANDA088372
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-03
LATEST ACTION
1991-12-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CYCLOPHOSPHAMIDEDiscontinued
CYCLOPHOSPHAMIDE 200MG/VIAL · INJECTABLE · INJECTION
Approval history
1991-12-03Labeling · Supplement 14AP
1991-05-07Manufacturing (CMC) · Supplement 13AP
1990-10-11Manufacturing (CMC) · Supplement 11AP
1990-09-17Labeling · Supplement 12AP
1990-06-29Manufacturing (CMC) · Supplement 10AP
1989-06-29Labeling · Supplement 9AP
1989-05-31Manufacturing (CMC) · Supplement 8AP
1988-11-08Labeling · Supplement 7AP
1988-05-18Manufacturing (CMC) · Supplement 4AP
1986-07-03OriginalAP
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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