HQ SPCLT PHARMA FDA Approval ANDA 207349

ANDA 207349

HQ SPCLT PHARMA

FDA Drug Application

Application #207349

Application Sponsors

ANDA 207349HQ SPCLT PHARMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1GM/100ML0MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERMAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2016-03-02STANDARD
LABELING; LabelingSUPPL5AP2019-11-27STANDARD
LABELING; LabelingSUPPL7AP2019-11-27STANDARD

Submissions Property Types

ORIG1Null15
SUPPL5Null7
SUPPL7Null7

TE Codes

001PrescriptionAP

CDER Filings

HQ SPCLT PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207349
            [companyName] => HQ SPCLT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"1GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/25\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-27
        )

)

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