Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 75MG BASE | 1 | TAMIFLU | OSELTAMIVIR PHOSPHATE |
002 | CAPSULE;ORAL | EQ 45MG BASE | 1 | TAMIFLU | OSELTAMIVIR PHOSPHATE |
003 | CAPSULE;ORAL | EQ 30MG BASE | 1 | TAMIFLU | OSELTAMIVIR PHOSPHATE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-10-27 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2000-11-17 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-11-09 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-03-06 | PRIORITY |
LABELING; Labeling | SUPPL | 5 | AP | 2001-07-24 | PRIORITY |
LABELING; Labeling | SUPPL | 6 | AP | 2001-07-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2001-07-13 | PRIORITY |
LABELING; Labeling | SUPPL | 8 | AP | 2001-07-24 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2001-11-05 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2002-04-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-03-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-05-07 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2003-03-10 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 14 | AP | 2003-02-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2003-02-28 | PRIORITY |
LABELING; Labeling | SUPPL | 16 | AP | 2004-06-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2004-04-26 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2004-04-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2004-08-12 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2004-10-19 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2005-01-18 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2005-04-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2005-05-19 | PRIORITY |
LABELING; Labeling | SUPPL | 25 | AP | 2005-10-27 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2005-08-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2005-10-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2005-10-14 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2005-12-01 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 30 | AP | 2005-12-21 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2006-06-23 | PRIORITY |
LABELING; Labeling | SUPPL | 33 | AP | 2006-11-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2006-12-19 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2007-02-01 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2007-02-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2007-03-12 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2007-03-22 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2007-03-26 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2007-07-02 | N/A |
LABELING; Labeling | SUPPL | 41 | AP | 2007-10-05 | STANDARD |
LABELING; Labeling | SUPPL | 42 | AP | 2008-01-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2008-05-05 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2007-12-03 | PRIORITY |
LABELING; Labeling | SUPPL | 45 | AP | 2010-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 2008-06-10 | STANDARD |
LABELING; Labeling | SUPPL | 47 | AP | 2008-09-25 | STANDARD |
LABELING; Labeling | SUPPL | 48 | AP | 2010-02-22 | STANDARD |
EFFICACY; Efficacy | SUPPL | 49 | AP | 2010-02-22 | PRIORITY |
LABELING; Labeling | SUPPL | 55 | AP | 2010-11-05 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2011-03-21 | STANDARD |
LABELING; Labeling | SUPPL | 57 | AP | 2011-02-07 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 59 | AP | 2012-08-16 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2014-11-26 | STANDARD |
LABELING; Labeling | SUPPL | 61 | AP | 2013-01-29 | STANDARD |
EFFICACY; Efficacy | SUPPL | 62 | AP | 2012-12-21 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 2013-12-20 | PRIORITY |
LABELING; Labeling | SUPPL | 64 | AP | 2014-05-30 | STANDARD |
LABELING; Labeling | SUPPL | 65 | AP | 2014-10-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2014-10-08 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 2014-12-15 | PRIORITY |
LABELING; Labeling | SUPPL | 68 | AP | 2016-06-20 | STANDARD |
LABELING; Labeling | SUPPL | 69 | AP | 2018-04-04 | STANDARD |
LABELING; Labeling | SUPPL | 70 | AP | 2018-12-12 | STANDARD |
EFFICACY; Efficacy | SUPPL | 71 | AP | 2019-08-02 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 8 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 34 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 0 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 0 |
SUPPL | 39 | Null | 0 |
SUPPL | 40 | Null | 4 |
SUPPL | 43 | Null | 0 |
SUPPL | 44 | Null | 0 |
SUPPL | 45 | Null | 6 |
SUPPL | 48 | Null | 6 |
SUPPL | 49 | Null | 6 |
SUPPL | 55 | Null | 7 |
SUPPL | 56 | Null | 6 |
SUPPL | 57 | Null | 6 |
SUPPL | 59 | Null | 15 |
SUPPL | 60 | Null | 6 |
SUPPL | 61 | Null | 6 |
SUPPL | 62 | Null | 7 |
SUPPL | 63 | Null | 0 |
SUPPL | 64 | Null | 15 |
SUPPL | 65 | Null | 15 |
SUPPL | 66 | Null | 0 |
SUPPL | 67 | Null | 0 |
SUPPL | 68 | Null | 15 |
SUPPL | 69 | Null | 6 |
SUPPL | 70 | Null | 7 |
SUPPL | 71 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
ROCHE
cder:Array
(
[0] => Array
(
[ApplNo] => 21087
[companyName] => ROCHE
[docInserts] => ["",""]
[products] => [{"drugName":"TAMIFLU","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TAMIFLU","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 45MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TAMIFLU","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/02\/2019","submission":"SUPPL-71","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-70","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/12\/2018","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/04\/2018","submission":"SUPPL-69","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-68","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-68","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-60","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-65","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-64","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-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021087s061,021246s044lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2013","submission":"SUPPL-61","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021087s061,021246s044lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2013","submission":"SUPPL-61","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021087s061,021246s044lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2012","submission":"SUPPL-62","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021087s062lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2012","submission":"SUPPL-59","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-56","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-57","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021087s057lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2010","submission":"SUPPL-45","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-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021087s055lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2010","submission":"SUPPL-49","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-48","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-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/17\/2008","submission":"SUPPL-42","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-41","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-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/02\/2007","submission":"SUPPL-40","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"11\/13\/2006","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021087s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2005","submission":"SUPPL-30","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021246s017_021087s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2005","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021087s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021087s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2005","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021087s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2004","submission":"SUPPL-16","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-10","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-9","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-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21087s8lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2001","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21087s5s6lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2001","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21087s5s6lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2000","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21087S002lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/21087lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TAMIFLU","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAMIFLU","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 45MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAMIFLU","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 30MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-08-02
)
)