NDA 207027

NOVARTIS

FDA Drug Application

Application #207027

Documents

• Summary Review: 2016-06-03
• Letter: 2015-08-25
• Label: 2015-08-25
• Review: 2016-06-03
• Letter: 2016-10-14
• Label: 2016-10-17
• Label: 2017-03-10
• Letter: 2017-03-14
• Label: 2017-07-10
• Pediatric Written Request: 2010-01-25
• Pediatric Amendment 1: 2011-11-23
• Letter: 2018-05-30
• Label: 2018-05-31
• Label: 2018-07-25
• Letter: 2018-07-26
• Letter: 2018-10-01
• Label: 2018-10-04
• Label: 2019-04-25
• Medication Guide: 2019-04-25
• Letter: 2020-04-30
• Label: 2020-05-01
• Medication Guide: 2020-05-01
• Pediatric Medical Review: 1900-01-01
• Letter: 2021-02-03
• Label: 2021-02-04
• Label: 2021-02-04
• Medication Guide: 2021-02-04
• Letter: 2021-02-04
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Letter: 2022-04-04
• Label: 2022-04-05
• Medication Guide: 2022-04-05

Application Sponsors

NDA 207027

NOVARTIS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 25MG ACID/PACKET	1	PROMACTA KIT	ELTROMBOPAG OLAMINE
002	FOR SUSPENSION;ORAL	EQ 12.5MG ACID/PACKET	1	PROMACTA KIT	ELTROMBOPAG OLAMINE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination	ORIG	1	AP	2015-08-24	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-03-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-07-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-05-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-07-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-09-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2020-10-08	N/A
LABELING; Labeling	SUPPL	14	AP	2021-02-03	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	6
SUPPL	6	Null	6
SUPPL	8	Null	6
SUPPL	10	Null	15
SUPPL	14	Null	6
SUPPL	15	Null	7

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207027
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/022291s033,207027s015lbl.pdf#page=35"]
            [products] => [{"drugName":"PROMACTA KIT","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 25MG ACID\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PROMACTA KIT","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 12.5MG ACID\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
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            [supplements] => [{"actionDate":"03\/31\/2022","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022291s033,207027s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"02\/03\/2021","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207027s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207027Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2020","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)-Facility","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207027Orig1s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207027Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"04\/29\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022291s027,207027s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"04\/24\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207027s008lbl.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207027s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207027Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"07\/24\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022291s020,207027s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/022291Orig1s020,207027Orig1s005Ltr.pdf\"}]","notes":">"},{"actionDate":"05\/25\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207027s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207027Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/05\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207027s003lbl.pdf\"}]","notes":">"},{"actionDate":"03\/09\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207027s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/022291Orig1s017,207027Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"10\/12\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022291s016,207027s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207027Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-03-31
        )

)