Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021036
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
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
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

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