Application 022088

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TORISEL	TEMSIROLIMUS	SOLUTION;INTRAVENOUS	25MG/ML (25MG/ML)	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0008-1179	Torisel	temsirolimus	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1179	Torisel	temsirolimus	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1179	Torisel	temsirolimus	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1179	Torisel	temsirolimus	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1179	Torisel	temsirolimus	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53505	SUPPL	2018-03-29
53504	SUPPL	2018-03-29
53466	SUPPL	2018-03-27
53465	SUPPL	2018-03-27
48515	SUPPL	2017-05-24
48512	SUPPL	2017-05-24
29228	SUPPL	2016-07-28
16926	SUPPL	2016-07-28
16925	SUPPL	2015-03-02
29227	SUPPL	2015-02-27
29226	SUPPL	2014-10-09
16924	SUPPL	2014-10-09
38215	SUPPL	2014-04-08
29225	SUPPL	2014-04-08
38214	SUPPL	2012-06-06
6861	SUPPL	2012-06-04
52362	SUPPL	2012-02-28
52361	SUPPL	2012-02-28
52360	SUPPL	2012-02-28
52359	SUPPL	2012-02-28
52358	SUPPL	2012-02-28
52357	SUPPL	2012-02-28
29224	SUPPL	2011-06-27
29223	SUPPL	2011-06-27
29222	SUPPL	2011-06-27
6860	SUPPL	2011-06-27
6858	SUPPL	2011-06-27
6856	SUPPL	2011-06-27
38213	SUPPL	2011-06-16
38212	SUPPL	2011-06-16
38211	SUPPL	2011-06-16
38210	SUPPL	2011-06-16
38209	SUPPL	2011-06-16
38208	SUPPL	2011-06-16
6859	SUPPL	2010-07-14
16923	SUPPL	2010-07-12
6857	SUPPL	2010-04-29
16922	SUPPL	2010-04-28
16921	SUPPL	2007-11-19
6855	SUPPL	2007-11-19
42411	ORIG	2007-07-30
16920	ORIG	2007-06-04
6854	ORIG	2007-06-04
53411	ORIG	1900-01-01
53410	ORIG	1900-01-01