Application 050709

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROGRAF	TACROLIMUS	INJECTABLE;INJECTION	EQ 5MG BASE/ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72704	SUPPL	2022-11-25
72690	SUPPL	2022-11-23
72689	SUPPL	2022-11-23
71267	SUPPL	2022-06-13
68117	SUPPL	2021-07-19
68101	SUPPL	2021-07-16
65799	SUPPL	2020-12-31
65786	SUPPL	2020-12-31
59031	SUPPL	2019-06-12
56674	SUPPL	2018-12-07
56630	SUPPL	2018-12-04
54354	SUPPL	2018-05-29
54348	SUPPL	2018-05-29
39152	SUPPL	2015-05-21
8062	SUPPL	2015-05-21
18067	SUPPL	2013-09-09
8061	SUPPL	2013-09-09
44517	SUPPL	2012-10-11
42686	SUPPL	2012-10-11
18066	SUPPL	2012-08-15
8060	SUPPL	2012-08-15
39151	SUPPL	2012-07-10
8059	SUPPL	2012-07-09
8058	SUPPL	2012-02-08
39150	SUPPL	2012-02-06
30317	SUPPL	2011-07-19
8057	SUPPL	2011-07-19
18065	SUPPL	2011-07-18
18064	SUPPL	2011-07-18
8055	SUPPL	2009-05-27
18063	SUPPL	2009-05-21
39149	SUPPL	2009-02-20
8056	SUPPL	2009-02-18
39148	SUPPL	2006-05-01
30316	SUPPL	2006-05-01
30315	SUPPL	2006-04-05
8054	SUPPL	2005-12-16
30314	SUPPL	2004-06-23
18062	SUPPL	2004-06-23
42685	ORIG	2003-09-10
39147	SUPPL	2003-05-02
18061	SUPPL	2003-05-02