NDA 022292

BOEHRINGER INGELHEIM

FDA Drug Application

Application #022292

Documents

• Letter: 2008-06-26
• Letter: 2009-06-24
• Letter: 2010-05-03
• Letter: 2010-09-07
• Label: 2008-06-26
• Label: 2010-05-07
• Label: 2012-02-22
• Letter: 2011-04-07
• Letter: 2012-02-27
• Letter: 2014-04-08
• Letter: 2015-04-01
• Label: 2009-06-24
• Label: 2010-08-16
• Label: 2011-04-06
• Label: 2014-04-08
• Label: 2015-04-07
• Review: 2010-05-12
• Summary Review: 2010-05-12
• Letter: 2016-09-20
• Label: 2016-09-23
• Label: 2018-06-28
• Letter: 2018-07-06
• Letter: 2020-06-19
• Label: 2020-06-22
• Label: 2020-06-22
• Label: 2020-06-22

Application Sponsors

NDA 022292

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

1

APTIVUS

TIPRANAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2008-06-23	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2010-04-27	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2010-08-16	STANDARD
LABELING; Labeling	SUPPL	4	AP	2011-04-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-02-17	901 REQUIRED
LABELING; Labeling	SUPPL	7	AP	2014-04-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-03-27	901 REQUIRED
LABELING; Labeling	SUPPL	9	AP	2016-09-15	901 REQUIRED
LABELING; Labeling	SUPPL	10	AP	2018-06-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-06-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-06-18	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2020-06-18	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	4
SUPPL	3	Null	7
SUPPL	4	Null	31
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	10	Null	7
SUPPL	14	Null	7

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22292
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"APTIVUS","activeIngredients":"TIPRANAVIR","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/18\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021814s021,022292s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021814s021,022292s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022292s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022292s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021814s016,022292s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021814s015,022292s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021814s015,022292s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021814s014,022292s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021814s013,022292s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022292s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2010","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022292s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021814s008,022292s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2009","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021814s006,022292s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021814s005,022292lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"APTIVUS","submission":"TIPRANAVIR","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-06-18
        )

)