NDA 214907

ON TARGET LABROTORIES, INC.

FDA Drug Application

Application #214907

Documents

• Letter: 2021-11-30
• Label: 2021-11-30
• Review: 2021-12-22
• Label: 2022-12-19
• Letter: 2022-12-20

Application Sponsors

NDA 214907

ON TARGET LABROTORIES, INC.

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3.2MG/1.6ML (2MG/ML)

0

CYTALUX

PAFOLACIANINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-11-29	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-12-16	PRIORITY

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	2

CDER Filings

ON TARGET LABROTORIES, INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214907
            [companyName] => ON TARGET LABROTORIES, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYTALUX","activeIngredients":"PAFOLACIANINE","strength":"3.2MG\/1.6ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214907s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/29\/2021","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\\\/214907s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214907Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-29
        )

)