NDA 203952

ABBVIE INC

FDA Drug Application

Application #203952

Documents

• Letter: 2015-01-15
• Review: 2016-07-19
• Label: 2015-01-14
• Letter: 2016-09-19
• Label: 2016-09-15
• Letter: 2019-12-06
• Label: 2019-12-06
• Label: 2020-05-22
• Letter: 2020-05-28

Application Sponsors

NDA 203952

ABBVIE INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ENTERAL

4.63MG/ML;20MG/ML

1

DUOPA

CARBIDOPA; LEVODOPA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2016-01-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-09-15	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-12-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-05-21	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	6
SUPPL	10	Orphan	5
SUPPL	11	Null	15

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203952
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"4.63MG\/ML;20MG\/ML","dosageForm":"SUSPENSION;ENTERAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/21\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203952s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203952s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203952s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203952s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/09\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203952s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203952Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/203952Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/21\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203952s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203952Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/05\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203952s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203952Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203952s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203952Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/22\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-21
        )

)