Drugs@FDA: FDA-Approved Drugs
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 |