APPLICATION
NDA012142
TYPE
NDA
ORIGINAL APPROVAL
1959-11-16
LATEST ACTION
2024-09-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CYTOXAN (LYOPHILIZED) · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LYOPHILIZED CYTOXAN · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN (LYOPHILIZED) · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN (LYOPHILIZED) · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN (LYOPHILIZED) · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LYOPHILIZED CYTOXAN · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN (LYOPHILIZED) · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN (LYOPHILIZED) · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTOXAN · ReferenceDiscontinued
CYCLOPHOSPHAMIDE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2016-10-31Manufacturing (CMC) · Supplement 115 · standardAP
2014-07-22Manufacturing (CMC) · Supplement 114 · priorityAP
2001-01-30Labeling · Supplement 103 · standardAP
2000-11-02Manufacturing (CMC) · Supplement 104 · priorityAP
2000-06-15Labeling · Supplement 101 · standardAP
1999-05-28Labeling · Supplement 102 · standardAP
1995-12-20Labeling · Supplement 98 · standardAP
1990-10-22Manufacturing (CMC) · Supplement 93 · priorityAP
1989-03-01Manufacturing (CMC) · Supplement 92 · priorityAP
1988-04-28Manufacturing (CMC) · Supplement 79 · priorityAP
1988-01-12Manufacturing (CMC) · Supplement 91 · priorityAP
1988-01-11Labeling · Supplement 90AP
1987-11-20Manufacturing (CMC) · Supplement 89 · priorityAP
1987-04-29Efficacy · Supplement 28AP
1987-04-29Labeling · Supplement 53AP
1987-04-29Manufacturing (CMC) · Supplement 88 · priorityAP
1986-12-08Labeling · Supplement 87AP
1986-12-08Labeling · Supplement 86AP
1986-07-11Labeling · Supplement 83AP
1986-07-11Labeling · Supplement 81AP
1986-07-11Labeling · Supplement 82AP
1986-05-30Labeling · Supplement 80AP
1986-05-30Labeling · Supplement 85AP
1986-05-30Labeling · Supplement 84AP
1986-02-14Labeling · Supplement 77AP
1985-12-10Labeling · Supplement 70AP
1985-12-05Labeling · Supplement 68AP
1985-09-24Labeling · Supplement 69AP
1985-08-30Manufacturing (CMC) · Supplement 75 · priorityAP
1985-08-30Labeling · Supplement 76AP
1985-08-06Manufacturing (CMC) · Supplement 57 · priorityAP
1985-06-18Manufacturing (CMC) · Supplement 73 · priorityAP
1985-05-06Manufacturing (CMC) · Supplement 72 · priorityAP
1985-05-02Manufacturing (CMC) · Supplement 74 · priorityAP
1984-12-10Manufacturing (CMC) · Supplement 71 · priorityAP
1984-10-17Labeling · Supplement 61AP
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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