Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019880
Company: CORDEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARAPLATIN CARBOPLATIN 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PARAPLATIN CARBOPLATIN 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PARAPLATIN CARBOPLATIN 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
03/03/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2010 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019880s020ltr.pdf
03/21/2002 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/30/2001 SUPPL-16 Labeling

Label is not available on this site.

09/14/2000 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/03/1999 SUPPL-13 Labeling

Label is not available on this site.

04/30/2001 SUPPL-12 Labeling

Label is not available on this site.

02/14/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19880s11ltr.pdf
11/15/1999 SUPPL-10 Labeling

Label is not available on this site.

01/06/1998 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19880S009_Paraplatin.pdf
03/17/1995 SUPPL-8 Labeling

Label is not available on this site.

02/23/1993 SUPPL-7 Labeling

Label is not available on this site.

08/17/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/12/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1991 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

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