Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | EQ 12MG BASE/ML | 0 | TAMIFLU | OSELTAMIVIR PHOSPHATE |
| 002 | FOR SUSPENSION;ORAL | EQ 6MG BASE/ML | 1 | TAMIFLU | OSELTAMIVIR PHOSPHATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-12-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-07-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2001-07-24 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2001-11-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-03-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2002-04-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2003-02-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2004-06-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2004-04-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2004-08-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2004-10-19 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2005-01-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2005-05-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2005-12-21 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2005-10-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2005-12-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2006-06-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 21 | AP | 2006-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2007-02-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2006-12-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2007-03-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2007-03-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2007-03-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2007-07-02 | N/A |
| LABELING; Labeling | SUPPL | 28 | AP | 2007-10-05 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2008-01-17 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2010-12-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2009-02-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 2008-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-02-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2010-02-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 38 | AP | 2010-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2011-03-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2011-02-07 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 42 | AP | 2012-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2014-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2013-01-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2012-12-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2013-02-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 47 | AP | 2014-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2014-10-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2015-03-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 51 | AP | 2016-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2018-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2018-12-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 54 | AP | 2019-08-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2021-08-10 | N/A |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 8 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 4 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 42 | Null | 15 |
| SUPPL | 43 | Null | 15 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 15 |
| SUPPL | 48 | Null | 31 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 54 | Null | 7 |
TE Codes
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 21246
[companyName] => ROCHE
[docInserts] => ["",""]
[products] => [{"drugName":"TAMIFLU","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 12MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TAMIFLU","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/02\/2019","submission":"SUPPL-54","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021087s071,021246s054lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/12\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/04\/2018","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021087s069,021246s052lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2016","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021087s068,021246s051lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2016","submission":"SUPPL-51","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021087s068,021246s051lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021087s060,021246s043lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2014","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021087s065,021246s048lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2014","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021087s064,021246s047lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2013","submission":"SUPPL-44","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021087s061,021246s044lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2012","submission":"SUPPL-45","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021246s045lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021087s059,021246s042lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2011","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021087s056_021246s039lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2011","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021246s040lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2010","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021087s045,021246s031lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2010","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021246s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2010","submission":"SUPPL-35","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021087s048s049,021246s034s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2010","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021087s048s049,021246s034s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2008","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/17\/2008","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021087s042,021246s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2007","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021087s041,021246s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2007","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/02\/2007","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"11\/13\/2006","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021246s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2005","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021246s017_021087s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2004","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21087slr016,21246slr010_Tamiflu_lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2002","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21087S10lbl_update.pdf\"}]","notes":""},{"actionDate":"11\/05\/2001","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21087s9lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2001","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21246s3lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2001","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21246s1lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21246LBL.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TAMIFLU","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 12MG BASE\/ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TAMIFLU","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 6MG BASE\/ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-08-02
)
)