APPLICATION
NDA017575
TYPE
NDA
ORIGINAL APPROVAL
1975-05-27
LATEST ACTION
1998-09-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DTIC-DOME · ReferenceDiscontinued
DACARBAZINE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DTIC-DOME · ReferenceDiscontinued
DACARBAZINE 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1998-09-24Manufacturing (CMC) · Supplement 20 · standardAP
1996-11-07Manufacturing (CMC) · Supplement 15 · standardAP
1996-05-24Manufacturing (CMC) · Supplement 19 · standardAP
1991-07-29Manufacturing (CMC) · Supplement 16 · standardAP
1989-04-19Manufacturing (CMC) · Supplement 13 · standardAP
1988-12-02Manufacturing (CMC) · Supplement 12 · standardAP
1986-05-22Labeling · Supplement 9AP
1985-07-15Manufacturing (CMC) · Supplement 6 · standardAP
1983-04-05Labeling · Supplement 7AP
1981-04-29Efficacy · Supplement 3AP
1980-10-27Manufacturing (CMC) · Supplement 4 · standardAP
1979-05-24Manufacturing (CMC) · Supplement 2 · standardAP
1975-11-10Manufacturing (CMC) · Supplement 1 · standardAP
1975-05-27Type 1 - New Molecular Entity · Original · standardAP
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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