ANDA 210155

AMNEAL PHARMS

FDA Drug Application

Application #210155

Documents

• Letter: 2018-03-15

Application Sponsors

ANDA 210155

AMNEAL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

500MG/PACKET

0

VIGABATRIN

VIGABATRIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-13	STANDARD
REMS; REMS	SUPPL	2	AP	2019-05-30
REMS; REMS	SUPPL	4	AP	2019-09-12
LABELING; Labeling	SUPPL	5	AP	2022-11-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-11-08	STANDARD
REMS; REMS	SUPPL	8	AP	2020-04-17
REMS; REMS	SUPPL	10	AP	2020-10-02
LABELING; Labeling	SUPPL	13	AP	2022-11-08	STANDARD
REMS; REMS	SUPPL	14	AP	2022-10-12

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AA

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210155
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210155Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-10","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-8","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/12\/2019","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2019","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-02
        )

)