INVAGEN PHARMS FDA Approval NDA 215395

NDA 215395

INVAGEN PHARMS

FDA Drug Application

Application #215395

Documents

Label2021-12-19
Letter2021-12-21

Application Sponsors

NDA 215395INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION60MG/0.2ML0LANREOTIDELANREOTIDE
002INJECTABLE;INJECTION90MG/0.3ML0LANREOTIDELANREOTIDE
003INJECTABLE;INJECTION120MG/0.5ML0LANREOTIDELANREOTIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-12-17STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215395
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANREOTIDE","activeIngredients":"LANREOTIDE","strength":"60MG\/0.2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LANREOTIDE","activeIngredients":"LANREOTIDE","strength":"90MG\/0.3ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LANREOTIDE","activeIngredients":"LANREOTIDE","strength":"120MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215395s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215395s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215395Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)

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