Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021087
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAMIFLU | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| TAMIFLU | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| TAMIFLU | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/27/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21087LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21087_Tamiflu.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/02/2019 | SUPPL-71 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021087s071,021246s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021087Orig1s071, 021246Orig1s054ltr.pdf | |
| 12/12/2018 | SUPPL-70 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s070lbl, 021246s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021087s070ltr, 021246s053ltr.pdf | |
| 04/04/2018 | SUPPL-69 | 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-68 | Labeling-Patient Package Insert, Labeling-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 | |
| 12/15/2014 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/2014 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/2014 | SUPPL-65 | 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-64 | 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 | |
| 12/20/2013 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/2012 | SUPPL-62 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s062lbl.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-61 | Labeling-Package Insert, Labeling-Patient Package Insert, 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-60 | 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-59 | 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-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf | |
| 03/21/2011 | SUPPL-56 | 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/2011/021087Orig1s056.pdf | |
| 11/05/2010 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf | |
| 02/22/2010 | SUPPL-49 | 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/2010/021087Orig1s049.pdf | |
| 02/22/2010 | SUPPL-48 | 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/2010/021087Orig1s048.pdf | |
| 09/25/2008 | SUPPL-47 | 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 | |
| 06/10/2008 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s046ltr.pdf |
| 12/15/2010 | SUPPL-45 | 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 | |
| 12/03/2007 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s044ltr.pdf |
| 05/05/2008 | SUPPL-43 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s043ltr.pdf |
| 01/17/2008 | SUPPL-42 | 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-41 | 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-40 | 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/2007/021087Orig1s040.pdf | |
| 03/26/2007 | SUPPL-39 | 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-38 | 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-37 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf |
| 02/27/2007 | SUPPL-36 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s036ltr.pdf |
| 02/01/2007 | SUPPL-35 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf |
| 12/19/2006 | SUPPL-34 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s034ltr.pdf |
| 11/13/2006 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033ppi.pdf | |
| 06/23/2006 | SUPPL-31 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf |
| 12/21/2005 | SUPPL-30 | 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/2005/021087Orig1s030.pdf | |
| 12/01/2005 | SUPPL-29 | 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-28 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf |
| 10/14/2005 | SUPPL-27 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s027ltr.pdf |
| 08/16/2005 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s026ltr.pdf | |
| 10/27/2005 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s025ltr.pdf | |
| 05/19/2005 | SUPPL-24 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf |
| 04/20/2005 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s023ltr.pdf | |
| 01/18/2005 | SUPPL-21 | 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-20 | 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-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/24/2004 | SUPPL-18 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf |
| 04/26/2004 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s017ltr.pdf |
| 06/24/2004 | SUPPL-16 | 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 | |
| 02/28/2003 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s015ltr.pdf |
| 02/14/2003 | SUPPL-14 | 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 |
| 03/10/2003 | SUPPL-13 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s013ltr.pdf |
| 05/07/2002 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S012_TamifluTOC.cfm |
| 03/28/2002 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S011_TamilfluTOC.cfm |
| 04/26/2002 | SUPPL-10 | 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 | |
| 11/05/2001 | SUPPL-9 | 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-8 | Labeling |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm | |
| 07/13/2001 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S007_TamifluTOC.cfm |
| 07/24/2001 | SUPPL-6 | Labeling |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm | |
| 07/24/2001 | SUPPL-5 | Labeling |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm | |
| 03/06/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S004_TamifluTOC.cfm |
| 11/09/2000 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S003_TamifluTOC.cfm |
| 11/17/2000 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21087s2.ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-087SE1-002_review.pdf | |
| 10/31/2000 | SUPPL-1 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S001_TamifluTOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/02/2019 | SUPPL-71 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021087s071,021246s054lbl.pdf | |
| 12/12/2018 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s070lbl, 021246s053lbl.pdf | |
| 12/12/2018 | SUPPL-70 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s070lbl, 021246s053lbl.pdf | |
| 04/04/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021087s069,021246s052lbl.pdf | |
| 06/20/2016 | SUPPL-68 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf | |
| 06/20/2016 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf | |
| 11/26/2014 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf | |
| 10/14/2014 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf | |
| 05/30/2014 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf | |
| 01/29/2013 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf | |
| 01/29/2013 | SUPPL-61 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf | |
| 01/29/2013 | SUPPL-61 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf | |
| 12/21/2012 | SUPPL-62 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s062lbl.pdf | |
| 08/16/2012 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf | |
| 03/21/2011 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf | |
| 02/07/2011 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s057lbl.pdf | |
| 12/15/2010 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf | |
| 11/05/2010 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf | |
| 02/22/2010 | SUPPL-49 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf | |
| 02/22/2010 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf | |
| 09/25/2008 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf | |
| 01/17/2008 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf | |
| 10/05/2007 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf | |
| 07/02/2007 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf | |
| 07/02/2007 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf | |
| 11/13/2006 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf | |
| 12/21/2005 | SUPPL-30 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf | |
| 10/27/2005 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf | |
| 08/16/2005 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf | |
| 04/20/2005 | SUPPL-23 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s023lbl.pdf | |
| 06/24/2004 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf | |
| 04/26/2002 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf | |
| 11/05/2001 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf | |
| 07/24/2001 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s8lbl.pdf | |
| 07/24/2001 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf | |
| 07/24/2001 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf | |
| 11/17/2000 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf | |
| 10/27/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf |
TAMIFLU
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211823 | ALEMBIC |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209093 | AMNEAL PHARMS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215208 | EPIC PHARMA LLC |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218009 | HAINAN POLY |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209438 | HETERO LABS LTD III |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217467 | INVAGEN PHARMS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218565 | LAURUS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208348 | LUPIN |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207211 | MACLEODS PHARMS LTD |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212544 | MSN |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202595 | NATCO |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209421 | STRIDES PHARMA |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212739 | SUNSHINE |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208578 | ZYDUS PHARMS |
| TAMIFLU | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021087 | ROCHE |
CAPSULE;ORAL; EQ 45MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211823 | ALEMBIC |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209093 | AMNEAL PHARMS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215208 | EPIC PHARMA LLC |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209438 | HETERO LABS LTD III |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217467 | INVAGEN PHARMS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218565 | LAURUS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208348 | LUPIN |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207211 | MACLEODS PHARMS LTD |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212544 | MSN |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202595 | NATCO |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209421 | STRIDES PHARMA |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212739 | SUNSHINE |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208578 | ZYDUS PHARMS |
| TAMIFLU | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021087 | ROCHE |
CAPSULE;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211823 | ALEMBIC |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209093 | AMNEAL PHARMS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215208 | EPIC PHARMA LLC |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209438 | HETERO LABS LTD III |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217467 | INVAGEN PHARMS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 218565 | LAURUS |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208348 | LUPIN |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207211 | MACLEODS PHARMS LTD |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212544 | MSN |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 202595 | NATCO |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209421 | STRIDES PHARMA |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212739 | SUNSHINE |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208578 | ZYDUS PHARMS |
| TAMIFLU | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021087 | ROCHE |