BRECKENRIDGE PHARMS FDA Approval ANDA 204135

ANDA 204135

BRECKENRIDGE PHARMS

FDA Drug Application

Application #204135

Documents

Letter2016-11-17

Application Sponsors

ANDA 204135BRECKENRIDGE PHARMS

Marketing Status

None (Tentative Approval)001

Application Products

001SOLUTION;ORAL17.5G;3.13G;1.6G0SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATESODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1TA2016-11-14

Submissions Property Types

ORIG1Null17

CDER Filings

BRECKENRIDGE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204135
            [companyName] => BRECKENRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"17.5G;3.13G;1.6G","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/14\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204135Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-14
        )

)

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