ANDA 210196

AUCTA

FDA Drug Application

Application #210196

Application Sponsors

ANDA 210196

AUCTA

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

500MG/PACKET

0

VIGADRONE

VIGABATRIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-06-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-08-08	STANDARD
REMS; REMS	SUPPL	3	AP	2019-09-12
LABELING; Labeling	SUPPL	4	AP	2022-08-08	STANDARD
REMS; REMS	SUPPL	5	AP	2020-04-17
LABELING; Labeling	SUPPL	6	AP	2022-08-08	STANDARD
REMS; REMS	SUPPL	7	AP	2020-10-02
LABELING; Labeling	SUPPL	12	AP	2022-08-08	STANDARD
REMS; REMS	SUPPL	14	AP	2022-10-12

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	12	Null	31
SUPPL	14	Null	15

TE Codes

001

Prescription

AA

CDER Filings

AUCTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210196
            [companyName] => AUCTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGADRONE","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-7","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/12\/2019","submission":"SUPPL-3","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2019","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A, REMS-Proposal","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-02
        )

)