Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020452
Company: CORDENPHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARAPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No
PARAPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No
PARAPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No
PARAPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/14/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-452.pdf_Paraplatin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20452ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-452_Paraplatin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020452s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020452s005ltr.pdf
01/09/2004 SUPPL-1 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20452scs001_paraplatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20452scs001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/05/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020452s005lbl.pdf
01/09/2004 SUPPL-1 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20452scs001_paraplatin_lbl.pdf
07/14/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-452.pdf_Paraplatin_Prntlbl.pdf

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