Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021036
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RELENZA | ZANAMIVIR | 5MG | POWDER;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21036.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021036s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021036Orig1s034ltr.pdf | |
| 10/19/2021 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021036s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021036Orig1s032ltr.pdf | |
| 06/21/2018 | SUPPL-30 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021036s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021036Orig1s030ltr.pdf | |
| 07/21/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2011 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021036s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021036s027ltr.pdf | |
| 12/09/2010 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s025ltr.pdf | |
| 05/04/2010 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s024ltr.pdf |
| 03/24/2010 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s019ltr.pdf | |
| 05/08/2009 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021036s018ltr.pdf |
| 10/02/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s017ltr.pdf | |
| 02/21/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s016ltr.pdf | |
| 12/13/2007 | SUPPL-15 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s015ltr.pdf |
| 06/27/2007 | SUPPL-14 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s014ltr.pdf |
| 03/09/2007 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s013ltr.pdf |
| 09/07/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021036s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s012ltr.pdf | |
| 11/22/2006 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s010ltr.pdf |
| 03/29/2006 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/29/2006 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021036s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021036Orig1s008.pdf | |
| 03/25/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021036s007ltr.pdf |
| 08/06/2003 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21036slr006_relenza_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr006ltr.pdf | |
| 08/05/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021036s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr005ltr.pdf | |
| 04/27/2001 | SUPPL-4 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21036S4lbl.pdf | |
| 05/18/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/2000 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21036S1LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21036S1LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-036-s001_Relenza.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021036s034lbl.pdf | |
| 10/19/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021036s032lbl.pdf | |
| 06/21/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021036s030lbl.pdf | |
| 06/21/2018 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021036s030lbl.pdf | |
| 12/20/2011 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021036s027lbl.pdf | |
| 12/09/2010 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s025lbl.pdf | |
| 03/24/2010 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf | |
| 10/02/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s017lbl.pdf | |
| 02/21/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s016lbl.pdf | |
| 09/07/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021036s012lbl.pdf | |
| 03/29/2006 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021036s008lbl.pdf | |
| 08/06/2003 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21036slr006_relenza_lbl.pdf | |
| 08/05/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021036s005lbl.pdf | |
| 04/27/2001 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21036S4lbl.pdf | |
| 04/26/2000 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21036S1LBL.PDF | |
| 07/26/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21036lbl.pdf |