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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010669
Company: WAYLIS THERAP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEUKERAN CHLORAMBUCIL 2MG TABLET;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/18/1957 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
10/28/2011 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010669s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010669s032ltr.pdf
04/23/2010 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010669s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010669s030ltr.pdf
05/24/2005 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010669s029ltr.pdf
11/13/2003 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/10669slr028_leukeran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10669slr028ltr.pdf
11/14/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
06/20/2001 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s24ltr.pdf
07/24/2001 SUPPL-23 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf
07/24/2001 SUPPL-22 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf
07/24/2001 SUPPL-21 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf
06/29/1995 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
02/04/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
02/09/1996 SUPPL-17 Labeling

Label is not available on this site.
10/14/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
02/28/1989 SUPPL-15 Labeling

Label is not available on this site.
03/06/1990 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/22/1986 SUPPL-12 Labeling

Label is not available on this site.
03/12/1984 SUPPL-11 Labeling

Label is not available on this site.
08/27/1981 SUPPL-9 Labeling

Label is not available on this site.
06/08/1978 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/22/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
03/09/1977 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/28/2011 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010669s032lbl.pdf
04/23/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010669s030lbl.pdf
11/13/2003 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/10669slr028_leukeran_lbl.pdf
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