LANNETT CO INC FDA Approval ANDA 209941

ANDA 209941

LANNETT CO INC

FDA Drug Application

Application #209941

Documents

Letter2022-02-04

Application Sponsors

ANDA 209941LANNETT CO INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2022-01-18STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209941
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE","strength":"1.6GM\/BOT;3.13GM\/BOT;17.5GM\/BOT","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209941Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-18
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.