Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020229
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUSTATIN CLADRIBINE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
02/26/1993 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Withdrawn FR Effective 11/03/2016

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2012 SUPPL-34 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020229s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020229Orig1s034ltr.pdf
06/29/2006 SUPPL-30 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020229s030ltr.pdf
08/22/2002 SUPPL-21 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr021ltr.pdf
08/20/2002 SUPPL-7 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf
08/20/2002 SUPPL-4 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2012 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020229s034lbl.pdf

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