LIPOCINE INC FDA Approval NDA 208088

NDA 208088

LIPOCINE INC

FDA Drug Application

Application #208088

Documents

Letter2020-12-09

Application Sponsors

NDA 208088LIPOCINE INC

Marketing Status

None (Tentative Approval)001

Application Products

001UNKNOWNUNKNOWN2TESTOSTERONE UNDECANOATETESTOSTERONE UNDECANOATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1TA2020-12-08STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

LIPOCINE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208088
            [companyName] => LIPOCINE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE UNDECANOATE","activeIngredients":"TESTOSTERONE UNDECANOATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208088Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-08
        )

)

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