Application 022059

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TYKERB	LAPATINIB DITOSYLATE	TABLET;ORAL	EQ 250MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0671	TYKERB	lapatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0671	TYKERB	lapatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0671	TYKERB	lapatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0671	TYKERB	lapatinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0671	TYKERB	lapatinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70628	SUPPL	2022-03-28
70623	SUPPL	2022-03-28
64841	SUPPL	2020-10-06
60093	SUPPL	2019-09-24
56658	SUPPL	2018-12-07
56657	SUPPL	2018-12-07
56642	SUPPL	2018-12-07
56641	SUPPL	2018-12-07
47973	SUPPL	2017-04-12
47890	SUPPL	2017-04-05
29180	SUPPL	2015-04-02
38169	SUPPL	2015-04-01
16868	SUPPL	2015-01-05
29181	SUPPL	2014-12-30
38168	SUPPL	2013-10-22
38167	SUPPL	2013-10-22
29178	SUPPL	2013-10-22
29177	SUPPL	2013-10-22
16867	SUPPL	2013-06-25
16866	SUPPL	2013-06-25
29179	SUPPL	2013-06-24
29176	SUPPL	2013-06-24
29175	SUPPL	2012-02-21
38166	SUPPL	2012-02-17
29174	SUPPL	2011-08-15
29173	SUPPL	2011-08-15
38165	SUPPL	2011-08-12
16865	SUPPL	2011-08-12
6793	SUPPL	2010-03-09
6792	SUPPL	2010-03-09
6794	SUPPL	2010-02-05
38164	SUPPL	2010-02-01
16864	SUPPL	2010-02-01
16862	SUPPL	2010-02-01
29172	SUPPL	2008-07-10
16863	SUPPL	2008-07-09
29171	SUPPL	2007-08-22
38163	SUPPL	2007-08-21
42404	ORIG	2007-05-09
16861	SUPPL	2007-05-01
6791	SUPPL	2007-05-01
29170	ORIG	2007-03-15
38162	ORIG	2007-03-13