NDA 213756

ASTRAZENECA LP

FDA Drug Application

Application #213756

Documents

• Label: 2020-04-10
• Letter: 2020-04-13
• Review: 2020-05-11
• Letter: 2021-12-23
• Label: 2021-12-23

Application Sponsors

NDA 213756

ASTRAZENECA LP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE; ORAL	25MG	2	KOSELUGO	SELUMETINIB SULFATE
002	CAPSULE; ORAL	10MG	2	KOSELUGO	SELUMETINIB SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-04-10	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	30
SUPPL	3	Orphan	5

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

ASTRAZENECA PHARMS

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(
    [0] => Array
        (
            [ApplNo] => 213756
            [companyName] => ASTRAZENECA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KOSELUGO","activeIngredients":"SELUMETINIB SULFATE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KOSELUGO","activeIngredients":"SELUMETINIB SULFATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/10\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213756s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213756s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213756Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213756Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-10
        )

)