Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103293
Company: CHIRON
Company: CHIRON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROLEUKIN | ALDESLEUKIN | 22MIU/VIAL | VIAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
05/05/1992 | ORIG-1 | Approval | N/A; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2023 | SUPPL-5154 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103293s51,54lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103293Orig1s5154ltr.pdf | |
05/17/2019 | SUPPL-5146 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103293Orig1s5146ltr.pdf |
05/06/2015 | SUPPL-5139 | Supplement |
Label is not available on this site. |
||
07/30/2012 | SUPPL-5130 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103293Orig1s5130ltr.pdf | |
12/16/2011 | SUPPL-5123 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5123ltr.pdf |
07/19/2011 | SUPPL-5114 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5114ltr.pdf |
07/06/2010 | SUPPL-5099 | Supplement |
Label is not available on this site. |
||
03/17/2010 | SUPPL-5088 | Supplement |
Label is not available on this site. |
||
04/08/2009 | SUPPL-5087 | Supplement |
Label is not available on this site. |
||
06/27/2000 | SUPPL-1029 | Supplement |
Label is not available on this site. |
||
01/09/1998 | SUPPL-1021 | Supplement |
Letter
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/aldechi010998L.htm https://web.archive.org/web/20170113111500/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080733.htm |
01/09/1998 | SUPPL-1019 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/29/2023 | SUPPL-5154 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103293s51,54lbl.pdf | |
07/30/2012 | SUPPL-5130 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf |