APPLICATION
NDA012141
TYPE
NDA
ORIGINAL APPROVAL
1959-11-16
LATEST ACTION
2020-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CYTOXAN · ReferencePrescription
CYCLOPHOSPHAMIDE 25MG · TABLET · ORAL
CYTOXAN · ReferencePrescription
CYCLOPHOSPHAMIDE 50MG · TABLET · ORAL
Approval history
2001-01-30Labeling · Supplement 86 · standardAP
2000-06-15Labeling · Supplement 83 · standardAP
1999-08-20Manufacturing (CMC) · Supplement 85 · priorityAP
1999-05-28Labeling · Supplement 84 · standardAP
1995-12-20Labeling · Supplement 81 · standardAP
1987-04-29Labeling · Supplement 63AP
1987-04-29Efficacy · Supplement 37AP
1987-04-29Manufacturing (CMC) · Supplement 77 · priorityAP
1986-07-11Labeling · Supplement 75AP
1986-07-11Labeling · Supplement 73AP
1986-07-11Labeling · Supplement 74AP
1986-07-11Labeling · Supplement 72AP
1986-01-15Labeling · Supplement 71AP
1985-12-05Manufacturing (CMC) · Supplement 67 · priorityAP
1985-12-04Labeling · Supplement 70AP
1985-08-30Manufacturing (CMC) · Supplement 69 · priorityAP
1984-08-10Manufacturing (CMC) · Supplement 66 · priorityAP
1983-03-15Labeling · Supplement 65AP
1982-07-28Manufacturing (CMC) · Supplement 62 · priorityAP
1982-03-04Manufacturing (CMC) · Supplement 64 · priorityAP
1981-02-27Manufacturing (CMC) · Supplement 60 · priorityAP
1980-09-27Labeling · Supplement 61AP
1980-01-25Manufacturing (CMC) · Supplement 57 · priorityAP
1979-08-03Manufacturing (CMC) · Supplement 59 · priorityAP
1979-05-24Manufacturing (CMC) · Supplement 58 · priorityAP
1979-04-30Manufacturing (CMC) · Supplement 56 · priorityAP
1978-11-27Manufacturing (CMC) · Supplement 53 · priorityAP
1978-08-28Manufacturing (CMC) · Supplement 55 · priorityAP
1978-08-16Supplement · Supplement 54 · priorityAP
1978-08-08Manufacturing (CMC) · Supplement 47 · priorityAP
1978-07-19Manufacturing (CMC) · Supplement 52 · priorityAP
1978-05-23Manufacturing (CMC) · Supplement 51 · priorityAP
1977-11-16Labeling · Supplement 49AP
1977-11-16Manufacturing (CMC) · Supplement 50 · priorityAP
1977-05-16Manufacturing (CMC) · Supplement 46 · priorityAP
1977-04-25Manufacturing (CMC) · Supplement 48 · priorityAP
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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