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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020452
Company: CORDENPHARMA

Products on NDA 020452

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PARAPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
PARAPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
PARAPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
PARAPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020452

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

Labels for NDA 020452

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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