NDA 212479

THERAKIND LIMITED

FDA Drug Application

Application #212479

Documents

• Letter: 2022-11-30
• Letter: 2022-11-30
• Letter: 2022-11-30
• Letter: 2022-11-30
• Label: 2022-12-02
• Label: 2022-12-02
• Label: 2022-12-02
• Label: 2022-12-02

Application Sponsors

NDA 212479

THERAKIND LIMITED

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;ORAL	2MG/ML	0	JYLAMVO	METHOTREXATE
002	SOLUTION;ORAL	2MG/ML	0	JYLAMVO	METHOTREXATE
003	SUSPENSION;ORAL	2MG/ML	0	JYLAMVO	METHOTREXATE
004	SOLUTION;ORAL	2MG/ML	0	JYLAMVO	METHOTREXATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2022-11-29	STANDARD
TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	2	AP	2022-11-29	STANDARD
TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	3	AP	2022-11-29	STANDARD
TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	4	AP	2022-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
ORIG	2	Null	6
ORIG	3	Null	6
ORIG	4	Null	6

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
        )

)