Application 021560

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZORTRESS	EVEROLIMUS	TABLET;ORAL	0.25MG	Yes	No
002	ZORTRESS	EVEROLIMUS	TABLET;ORAL	0.5MG	Yes	No
003	ZORTRESS	EVEROLIMUS	TABLET;ORAL	0.75MG	Yes	Yes
004	ZORTRESS	EVEROLIMUS	TABLET;ORAL	1MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77673	SUPPL	2024-02-29
77672	SUPPL	2024-02-29
75497	SUPPL	2023-09-15
75473	SUPPL	2023-09-15
74478	SUPPL	2023-06-13
64271	SUPPL	2020-08-12
64270	SUPPL	2020-08-12
64269	SUPPL	2020-08-12
51079	SUPPL	2018-01-18
51078	SUPPL	2018-01-18
51068	SUPPL	2018-01-17
51060	SUPPL	2018-01-17
45622	SUPPL	2016-10-17
45546	SUPPL	2016-10-14
37226	SUPPL	2015-11-12
5738	SUPPL	2015-11-09
37225	SUPPL	2015-01-30
28116	SUPPL	2015-01-28
15777	SUPPL	2013-02-20
5734	SUPPL	2013-02-20
37224	SUPPL	2012-10-04
5736	SUPPL	2012-10-04
5737	SUPPL	2012-05-04
37223	SUPPL	2012-05-01
5735	SUPPL	2012-04-27
28115	SUPPL	2011-11-28
24205	ORIG	2010-06-16
21734	ORIG	2010-06-16
37222	ORIG	2010-05-03
28114	ORIG	2010-04-29

Application 021560

Related Records#

Application Products#

NDC Listings For This Application#

Documents#