Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021246
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 12MG BASE/ML FOR SUSPENSION;ORAL Discontinued None No No
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription AB 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
12/14/2000 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21246LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21246ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-246_Tamiflu.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/04/2018 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s069,021246s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021087Orig1s069,021246Orig1s052ltr.pdf
06/20/2016 SUPPL-51 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf
03/16/2015 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/14/2014 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf
05/30/2014 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf
02/07/2013 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/21/2012 SUPPL-45 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021246s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf
01/29/2013 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf
11/26/2014 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf
08/16/2012 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf
02/07/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021246s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf
03/21/2011 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021246Orig1s039.pdf
11/05/2010 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021246s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf
02/22/2010 SUPPL-35 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s035.pdf
02/22/2010 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s034.pdf
09/25/2008 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf
02/23/2009 SUPPL-32 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021246s032ltr.pdf
12/15/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf
01/17/2008 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf
10/05/2007 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf
07/02/2007 SUPPL-27 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021246Orig1s027.pdf
03/26/2007 SUPPL-26 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf
03/22/2007 SUPPL-25 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf
03/12/2007 SUPPL-24 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf
12/14/2006 SUPPL-23 Manufacturing (CMC)-Manufacturing Process Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021246s023ltr.pdf
02/01/2007 SUPPL-22 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf
11/13/2006 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021ppi.pdf
06/23/2006 SUPPL-20 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf
12/01/2005 SUPPL-19 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf
10/14/2005 SUPPL-18 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf
12/21/2005 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021246Orig1s017.pdf
05/19/2005 SUPPL-16 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf
01/18/2005 SUPPL-14 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf
10/19/2004 SUPPL-13 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf
08/12/2004 SUPPL-12 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s019_021246s012ltr.pdf
04/26/2004 SUPPL-11 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf
06/24/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm
02/14/2003 SUPPL-8 Efficacy-Accelerated Approval Confirmatory Study Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf
04/26/2002 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm
03/04/2002 SUPPL-6 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021246_S006_TamifluTOC.cfm
11/05/2001 SUPPL-4 Labeling Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm
07/24/2001 SUPPL-3 Labeling Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm
07/05/2001 SUPPL-2 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021246_S002_TamifluTOC.cfm
07/24/2001 SUPPL-1 Labeling Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/2018 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s069,021246s052lbl.pdf
06/20/2016 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf
06/20/2016 SUPPL-51 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf
11/26/2014 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf
10/14/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf
05/30/2014 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf
01/29/2013 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf
12/21/2012 SUPPL-45 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021246s045lbl.pdf
08/16/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf
03/21/2011 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf
02/07/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021246s040lbl.pdf
12/15/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf
11/05/2010 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021246s038lbl.pdf
02/22/2010 SUPPL-35 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf
02/22/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf
09/25/2008 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf
01/17/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf
10/05/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf
07/02/2007 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf
07/02/2007 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf
11/13/2006 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021lbl.pdf
12/21/2005 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf
06/24/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf
04/26/2002 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf
11/05/2001 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf
07/24/2001 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s3lbl.pdf
07/24/2001 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s1lbl.pdf
12/14/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21246LBL.pdf

TAMIFLU

FOR SUSPENSION;ORAL; EQ 6MG BASE/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 208823 ALVOGEN PINE BROOK
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 210186 AMNEAL PHARMS NY
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 208347 LUPIN ATLANTIS
OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription No AB 209113 NESHER PHARMS
TAMIFLU OSELTAMIVIR PHOSPHATE EQ 6MG BASE/ML FOR SUSPENSION;ORAL Prescription Yes AB 021246 ROCHE

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