NDA 213702

PHARMA MAR USA INC

FDA Drug Application

Application #213702

Documents

• Label: 2020-06-15
• Letter: 2020-06-16
• Review: 2020-07-14
• Letter: 2022-04-04
• Label: 2022-04-05

Application Sponsors

NDA 213702

PHARMA MAR USA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4MG

2

ZEPZELCA

LURBINECTEDIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-06-15	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2022-04-01	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Orphan	5

CDER Filings

JAZZ

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213702
            [companyName] => JAZZ
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEPZELCA","activeIngredients":"LURBINECTEDIN","strength":"4MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/15\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213702s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/15\/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\\\/213702s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213702Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-15
        )

)