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FDA NDA · NDA020452

PARAPLATIN

Sponsor: CORDENPHARMA

APPLICATION
NDA020452
TYPE
NDA
ORIGINAL APPROVAL
2003-07-14
LATEST ACTION
2010-11-05
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 600MG/60ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 450MG/45ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
PARAPLATIN · ReferenceDiscontinued
CARBOPLATIN 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2010-11-05Labeling · Supplement 5 · unknown — Label ↗AP
2004-01-09Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2003-07-14Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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