Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009386
Company: WAYLIS THERAP
Company: WAYLIS THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYLERAN | BUSULFAN | 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 |
|---|---|---|---|---|---|---|---|
| 06/26/1954 | 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 |
|---|---|---|---|---|---|
| 12/24/2003 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr023ltr.pdf | |
| 04/16/2003 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr021ltr.pdf | |
| 09/20/2002 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/23/2003 | SUPPL-19 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386scm019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/9-386s019_Myleran.cfm | |
| 09/06/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/23/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/15/1991 | SUPPL-13 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.pdf | |
| 09/17/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/20/1990 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/09/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/19/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/11/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/08/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/10/1977 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/21/1975 | SUPPL-4 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/24/2003 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pdf | |
| 04/16/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pdf | |
| 01/23/2003 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf |
| 07/15/1991 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.pdf |