Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020229
Company: JANSSEN PHARMS

Products on NDA 020229

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LEUSTATIN	CLADRIBINE	1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020229

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02/26/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Withdrawn FR Effective 11/03/2016 Label is not available on this site.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

Labels for NDA 020229

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