Application 203985

Type: NDA
Sponsor: NOVARTIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AFINITOR DISPERZ	EVEROLIMUS	TABLET, FOR SUSPENSION;ORAL	2MG	Yes	No
002	AFINITOR DISPERZ	EVEROLIMUS	TABLET, FOR SUSPENSION;ORAL	3MG	Yes	No
003	AFINITOR DISPERZ	EVEROLIMUS	TABLET, FOR SUSPENSION;ORAL	5MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78399	SUPPL	2024-05-06
78397	SUPPL	2024-05-06
70062	SUPPL	2022-02-03
70046	SUPPL	2022-02-02
67111	SUPPL	2021-04-19
67104	SUPPL	2021-04-19
61897	SUPPL	2020-02-14
61892	SUPPL	2020-02-14
61630	SUPPL	2020-01-23
61625	SUPPL	2020-01-23
53648	SUPPL	2018-04-11
40337	SUPPL	2016-02-02
10267	SUPPL	2016-02-01
19509	SUPPL	2015-01-29
10266	SUPPL	2015-01-26
10265	SUPPL	2014-07-03
19508	SUPPL	2014-07-02
40336	SUPPL	2014-02-21
40334	SUPPL	2014-02-21
32487	SUPPL	2014-02-21
32485	SUPPL	2014-02-21
19507	SUPPL	2014-02-21
10264	SUPPL	2014-02-21
44891	ORIG	2013-11-12
22939	ORIG	2013-11-12
40335	SUPPL	2013-11-08
32486	SUPPL	2013-11-07
10263	ORIG	2012-08-31
19506	ORIG	2012-08-29
58107	ORIG	1900-01-01
51099	ORIG	1900-01-01
51098	ORIG	1900-01-01
51097	ORIG	1900-01-01

Application 203985

Related Records#

Application Products#

NDC Listings For This Application#

Documents#