Application 205755

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYKADIA	CERITINIB	CAPSULE;ORAL	150MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0640	ZYKADIA	ceritinib	Novartis Pharmaceuticals	NDA	Current
0078-0640	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68978	SUPPL	2021-10-13
68953	SUPPL	2021-10-12
68446	SUPPL	2021-08-24
68436	SUPPL	2021-08-22
57916	SUPPL	2019-03-14
57923	SUPPL	2019-03-07
50928	SUPPL	2017-12-27
50855	SUPPL	2017-12-26
50493	SUPPL	2017-11-27
50468	SUPPL	2017-11-21
49036	SUPPL	2017-07-21
49028	SUPPL	2017-07-20
48638	SUPPL	2017-06-02
48601	SUPPL	2017-05-31
45256	SUPPL	2016-09-09
45271	SUPPL	2016-09-08
40500	SUPPL	2015-07-24
19681	SUPPL	2015-07-24
32716	SUPPL	2015-07-23
10495	SUPPL	2015-07-23
43502	ORIG	2014-05-16
24503	ORIG	2014-05-16
32715	ORIG	2014-04-30
19680	ORIG	2014-04-29