Application 022334

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AFINITOR	EVEROLIMUS	TABLET;ORAL	5MG	Yes	Yes
002	AFINITOR	EVEROLIMUS	TABLET;ORAL	10MG	Yes	No
003	AFINITOR	EVEROLIMUS	TABLET;ORAL	2.5MG	Yes	No
004	AFINITOR	EVEROLIMUS	TABLET;ORAL	7.5MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0566	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0567	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0594	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0620	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70061	SUPPL	2022-02-03
70047	SUPPL	2022-02-02
69930	SUPPL	2022-01-20
67110	SUPPL	2021-04-19
67103	SUPPL	2021-04-19
61896	SUPPL	2020-02-14
61891	SUPPL	2020-02-14
61629	SUPPL	2020-01-23
61624	SUPPL	2020-01-23
53655	SUPPL	2018-04-12
53647	SUPPL	2018-04-11
49876	SUPPL	2017-09-28
49868	SUPPL	2017-09-28
17269	SUPPL	2016-06-17
29618	SUPPL	2016-06-16
7264	SUPPL	2016-02-29
38597	SUPPL	2016-02-26
7263	SUPPL	2016-02-23
38596	SUPPL	2016-02-11
7262	SUPPL	2016-02-05
17268	SUPPL	2016-02-02
7261	SUPPL	2016-02-01
17267	SUPPL	2015-09-23
7260	SUPPL	2015-09-22
38595	SUPPL	2015-05-27
7259	SUPPL	2015-05-26
17266	SUPPL	2015-01-29
7258	SUPPL	2015-01-26
29617	SUPPL	2014-12-19
17265	SUPPL	2014-12-19
7257	SUPPL	2014-07-03
17264	SUPPL	2014-07-02
38594	SUPPL	2014-02-21
29616	SUPPL	2014-02-21
29615	SUPPL	2014-02-21
29614	SUPPL	2014-02-21
17263	SUPPL	2014-02-21
17261	SUPPL	2014-02-21
17262	SUPPL	2013-11-08
7256	SUPPL	2013-11-07
42494	SUPPL	2013-10-21
17260	SUPPL	2012-08-31
7255	SUPPL	2012-08-31
7253	SUPPL	2012-07-23
38592	SUPPL	2012-07-20
7254	SUPPL	2012-05-02
38593	SUPPL	2012-04-26
38591	SUPPL	2012-04-02
29613	SUPPL	2012-04-02
29612	SUPPL	2012-04-02
17259	SUPPL	2012-04-02
29611	SUPPL	2011-05-10
7252	SUPPL	2011-05-10
38590	SUPPL	2011-05-06
17258	SUPPL	2011-05-06
7251	SUPPL	2010-11-04
17257	SUPPL	2010-11-01
7250	SUPPL	2010-07-14
17256	SUPPL	2010-07-12
29610	SUPPL	2010-05-18
17255	SUPPL	2010-05-17
51730	ORIG	2010-04-01
24285	ORIG	2009-05-15
21997	ORIG	2009-05-15
29609	ORIG	2009-04-03
17254	ORIG	2009-04-03
54060	ORIG	1900-01-01
53272	ORIG	1900-01-01

Application 022334

Related Records#

Application Products#

NDC Listings For This Application#

Documents#