PAR PHARM INC FDA Approval ANDA 208218

ANDA 208218

PAR PHARM INC

FDA Drug Application

Application #208218

Documents

Letter2017-05-02

Application Sponsors

ANDA 208218PAR PHARM INC

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL500MG/PACKET0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2017-04-27STANDARD
REMS; REMSSUPPL2AP2017-10-23
REMS; REMSSUPPL4AP2019-05-30
LABELING; LabelingSUPPL6AP2020-03-12STANDARD
REMS; REMSSUPPL7AP2019-09-12
LABELING; LabelingSUPPL8AP2020-03-12STANDARD
REMS; REMSSUPPL9AP2020-04-17
REMS; REMSSUPPL11AP2020-10-02
REMS; REMSSUPPL13AP2022-10-12

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL4Null7
SUPPL6Null7
SUPPL7Null7
SUPPL8Null15
SUPPL9Null15
SUPPL11Null7
SUPPL13Null15

TE Codes

001PrescriptionAA

CDER Filings

PAR PHARM INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208218
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208218Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-11","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-9","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/12\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/12\/2019","submission":"SUPPL-7","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/12\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2019","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/23\/2017","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/12\/2020","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-02
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.