NDA 209512

ABBVIE INC

FDA Drug Application

Application #209512

Documents

• Label: 2017-06-08
• Label: 2017-06-30
• Letter: 2017-06-30
• Label: 2017-10-03
• Letter: 2017-10-03
• Letter: 2018-03-08
• Review: 2018-03-14
• Label: 2018-11-23
• Letter: 2018-12-07
• Letter: 2019-08-22
• Label: 2019-08-22
• Letter: 2019-12-23
• Label: 2019-12-31
• Letter: 2020-10-22
• Label: 2020-10-23
• Letter: 2022-12-16
• Label: 2022-12-20

Application Sponsors

NDA 209512

ABBVIE INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;ORAL

100MG/PACKET

1

NORVIR

RITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-06-07	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-09-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-11-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-12-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-06-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6
SUPPL	4	Null	15
SUPPL	5	Null	6
SUPPL	6	Null	7
SUPPL	7	Null	7

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209512
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORVIR","activeIngredients":"RITONAVIR","strength":"100MG\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/19\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/19\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020659s070,022417s022,209512s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020659s070,022417s022,209512s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209512s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512s002,022417s020,020659s068lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512s002,022417s020,020659s068lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020659s066,022417s018,209512s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020659s066,022417s018,209512s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209512Orig1s000Approv.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209512Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/19\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/21\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020659s070,022417s022,209512s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/15\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209512s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/020659Orig1s069,022417Orig1s021,0209512Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/29\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209512s002,022417s020,020659s068lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020659s066,022417s018,209512s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-19
        )

)