APPLICATION
ANDA087442
TYPE
ANDA
ORIGINAL APPROVAL
1982-02-16
LATEST ACTION
2002-03-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NEOSARDiscontinued
CYCLOPHOSPHAMIDE 2GM/VIAL · INJECTABLE · INJECTION
NEOSARDiscontinued
CYCLOPHOSPHAMIDE 500MG/VIAL · INJECTABLE · INJECTION
NEOSARDiscontinued
CYCLOPHOSPHAMIDE 100MG/VIAL · INJECTABLE · INJECTION
NEOSARDiscontinued
CYCLOPHOSPHAMIDE 1GM/VIAL · INJECTABLE · INJECTION
NEOSARDiscontinued
CYCLOPHOSPHAMIDE 200MG/VIAL · INJECTABLE · INJECTION
Approval history
2002-03-25Labeling · Supplement 22AP
1997-03-03Labeling · Supplement 21AP
1993-08-19Labeling · Supplement 20AP
1992-08-06Manufacturing (CMC) · Supplement 19AP
1991-10-03Labeling · Supplement 18AP
1991-01-30Manufacturing (CMC) · Supplement 17AP
1990-04-13Labeling · Supplement 16AP
1989-03-30Manufacturing (CMC) · Supplement 14AP
1989-03-30Manufacturing (CMC) · Supplement 12AP
1989-03-30Labeling · Supplement 15AP
1989-03-30Manufacturing (CMC) · Supplement 13AP
1988-11-18Labeling · Supplement 11AP
1988-02-12Manufacturing (CMC) · Supplement 10AP
1986-07-10Manufacturing (CMC) · Supplement 6AP
1983-07-08Manufacturing (CMC) · Supplement 2AP
1982-02-16OriginalAP
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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