APPLICATION
NDA019880
TYPE
NDA
ORIGINAL APPROVAL
1989-03-03
LATEST ACTION
2010-11-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-03-21Manufacturing (CMC) · Supplement 18 · priorityAP
2001-04-30Labeling · Supplement 16 · standardAP
2001-04-30Labeling · Supplement 12 · standardAP
2000-11-02Manufacturing (CMC) · Supplement 17 · priorityAP
2000-09-14Manufacturing (CMC) · Supplement 15 · priorityAP
2000-09-07Manufacturing (CMC) · Supplement 14 · priorityAP
1999-12-03Labeling · Supplement 13 · standardAP
1999-11-15Labeling · Supplement 10 · standardAP
1995-03-17Labeling · Supplement 8 · standardAP
1993-02-23Labeling · Supplement 7 · standardAP
1991-07-05Efficacy · Supplement 1AP
1990-08-17Manufacturing (CMC) · Supplement 4 · priorityAP
1990-06-12Manufacturing (CMC) · Supplement 3 · priorityAP
1989-03-03Type 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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