THERAKIND LIMITED FDA Approval NDA 212479

NDA 212479

THERAKIND LIMITED

FDA Drug Application

Application #212479

Documents

Letter2022-11-30
Letter2022-11-30
Letter2022-11-30
Letter2022-11-30
Label2022-12-02
Label2022-12-02
Label2022-12-02
Label2022-12-02

Application Sponsors

NDA 212479THERAKIND LIMITED

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SOLUTION;ORAL2MG/ML0JYLAMVOMETHOTREXATE
002SOLUTION;ORAL2MG/ML0JYLAMVOMETHOTREXATE
003SUSPENSION;ORAL2MG/ML0JYLAMVOMETHOTREXATE
004SOLUTION;ORAL2MG/ML0JYLAMVOMETHOTREXATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-11-29STANDARD
TYPE 5; Type 5 - New Formulation or New ManufacturerORIG2AP2022-11-29STANDARD
TYPE 5; Type 5 - New Formulation or New ManufacturerORIG3AP2022-11-29STANDARD
TYPE 5; Type 5 - New Formulation or New ManufacturerORIG4AP2022-11-29STANDARD

Submissions Property Types

ORIG1Null6
ORIG2Null6
ORIG3Null6
ORIG4Null6

CDER Filings

THERAKIND LIMITED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212479
            [companyName] => THERAKIND LIMITED
            [docInserts] => ["",""]
            [products] => [{"drugName":"JYLAMVO","activeIngredients":"METHOTREXATE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"JYLAMVO","activeIngredients":"METHOTREXATE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"JYLAMVO","activeIngredients":"METHOTREXATE","strength":"2MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"JYLAMVO","activeIngredients":"METHOTREXATE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2022","submission":"ORIG-4","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212479s000lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2022","submission":"ORIG-3","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212479s000lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2022","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212479s000lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/212479s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/29\/2022","submission":"ORIG-4","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\\\/212479s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/29\/2022","submission":"ORIG-3","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\\\/212479s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/29\/2022","submission":"ORIG-2","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\\\/212479s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/29\/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\\\/212479s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-11-29
        )

)

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