MERIDIAN LABORATORIES INC FDA Approval NDA 215813

NDA 215813

MERIDIAN LABORATORIES INC

FDA Drug Application

Application #215813

Documents

Label2022-11-23
Letter2022-11-25

Application Sponsors

NDA 215813MERIDIAN LABORATORIES INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION10MG/ML0DOCETAXELDOCETAXEL
002INJECTABLE;INJECTION20MG/2ML0DOCETAXELDOCETAXEL
003INJECTABLE;INJECTION80MG/8ML0DOCETAXELDOCETAXEL
004INJECTABLE;INJECTION160MG/16ML0DOCETAXELDOCETAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-11-22STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

MERIDIAN LABORATORIES INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215813
            [companyName] => MERIDIAN LABORATORIES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/16ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215813s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/22\/2022","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\\\/2022\\\/215813s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215813Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-11-22
        )

)

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