Application 050791

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYFORTIC	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	180MG	Yes	No
002	MYFORTIC	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	360MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82710	SUPPL	2025-06-30
82704	SUPPL	2025-06-30
79389	SUPPL	2024-08-14
70534	SUPPL	2022-03-16
70533	SUPPL	2022-03-16
70527	SUPPL	2022-03-16
68362	SUPPL	2021-08-13
67159	SUPPL	2021-04-23
66806	SUPPL	2021-03-18
66792	SUPPL	2021-03-17
65941	SUPPL	2021-01-19
62740	SUPPL	2020-04-29
62739	SUPPL	2020-04-29
62735	SUPPL	2020-04-29
56377	SUPPL	2018-11-08
30562	SUPPL	2015-11-16
39341	SUPPL	2015-10-29
8299	SUPPL	2015-10-29
8298	SUPPL	2015-08-12
30561	SUPPL	2013-10-01
8297	SUPPL	2013-10-01
18261	SUPPL	2013-09-30
18260	SUPPL	2013-09-30
39340	SUPPL	2013-05-09
30559	SUPPL	2013-05-07
30554	SUPPL	2012-09-27
24040	ORIG	2012-09-27
30560	SUPPL	2012-06-26
18259	SUPPL	2012-06-26
30558	SUPPL	2010-11-03
18258	SUPPL	2010-10-28
30557	SUPPL	2009-11-09
23425	ORIG	2009-10-16
18257	SUPPL	2009-10-14
30556	SUPPL	2009-07-17
44209	ORIG	2009-07-15
18256	SUPPL	2009-07-14
30555	SUPPL	2009-04-01
18255	SUPPL	2009-01-02
30553	SUPPL	2008-12-19
18254	SUPPL	2008-05-16
30552	SUPPL	2008-05-14
30551	SUPPL	2007-11-08
39339	SUPPL	2007-11-07
22241	ORIG	2005-04-27
30550	ORIG	2004-03-03