NDA 209936

BAYER HEALTHCARE

FDA Drug Application

Application #209936

Documents

• Label: 2017-09-14
• Letter: 2017-09-14
• Review: 2017-10-16
• Label: 2019-05-29
• Letter: 2019-06-04
• Label: 2019-10-29
• Letter: 2019-10-29
• Label: 2020-02-13
• Letter: 2020-02-13
• Letter: 2022-02-24
• Label: 2022-02-25

Application Sponsors

NDA 209936

BAYER HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

60MG/VIAL

1

ALIQOPA

COPANLISIB DIHYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-09-14	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2019-05-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-10-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-05-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-02-23	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	10	Null	7

CDER Filings

BAYER HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209936
            [companyName] => BAYER HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALIQOPA","activeIngredients":"COPANLISIB DIHYDROCHLORIDE","strength":"60MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209936s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209936s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209936s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209936s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/14\/2017","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\\\/2017\\\/209936s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209936Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209936Orig1_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209936s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209936Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/28\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209936s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209936Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"05\/24\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209936s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209936Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-02-12
        )

)