NDA 208088

LIPOCINE INC

FDA Drug Application

Application #208088

Documents

• Letter: 2020-12-09
• Label: 2022-03-29
• Letter: 2022-03-29

Application Sponsors

NDA 208088

LIPOCINE INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

UNKNOWN

UNKNOWN

2

TESTOSTERONE UNDECANOATE

TESTOSTERONE UNDECANOATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2020-12-08

STANDARD

Submissions Property Types

ORIG

1

Null

6

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
        )

)