APPLICATION
NDA016793
TYPE
NDA
ORIGINAL APPROVAL
1969-06-17
LATEST ACTION
2000-04-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CYTARABINE · ReferenceDiscontinued
CYTARABINE 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTARABINE · ReferenceDiscontinued
CYTARABINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTARABINE · ReferenceDiscontinued
CYTARABINE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CYTARABINE · ReferenceDiscontinued
CYTARABINE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-04-03Manufacturing (CMC) · Supplement 60 · priorityAP
1996-01-24Labeling · Supplement 58 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 57 · priorityAP
1995-06-14Labeling · Supplement 56 · standardAP
1994-09-27Manufacturing (CMC) · Supplement 55 · priorityAP
1990-01-08Labeling · Supplement 52AP
1987-12-21Manufacturing (CMC) · Supplement 47 · priorityAP
1987-12-21Labeling · Supplement 51AP
1987-04-17Labeling · Supplement 49AP
1987-02-24Manufacturing (CMC) · Supplement 50 · priorityAP
1986-07-28Manufacturing (CMC) · Supplement 46 · priorityAP
1986-01-31Manufacturing (CMC) · Supplement 39 · priorityAP
1983-10-21Labeling · Supplement 41AP
1983-05-11Labeling · Supplement 38AP
1982-12-30Labeling · Supplement 37AP
1981-03-31Manufacturing (CMC) · Supplement 34 · priorityAP
1979-10-29Labeling · Supplement 32AP
1979-02-23Labeling · Supplement 33AP
1976-03-10Manufacturing (CMC) · Supplement 30 · priorityAP
1975-10-23Manufacturing (CMC) · Supplement 29 · priorityAP
1974-04-24REMS · Supplement 25 · priorityAP
1969-06-17Type 1 - New Molecular Entity · Original · 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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