Application 021540

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 10MG BASE	Yes	No
002	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 20MG BASE	Yes	No
003	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 40MG BASE	Yes	No
004	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 80MG BASE	Yes	No
005	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 10MG BASE	Yes	No
006	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 20MG BASE	Yes	No
007	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 40MG BASE	Yes	No
008	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 80MG BASE	Yes	Yes
009	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 2.5MG BASE;EQ 10MG BASE	Yes	No
010	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 2.5MG BASE;EQ 20MG BASE	Yes	No
011	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 2.5MG BASE;EQ 40MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2150	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2160	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2170	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2180	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2190	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2250	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2260	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-2270	Caduet	amlodipine besylate and atorvastatin calcium	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80148	SUPPL	2024-11-05
78524	SUPPL	2024-05-21
78515	SUPPL	2024-05-20
66207	SUPPL	2021-02-12
65950	SUPPL	2021-01-21
65869	SUPPL	2021-01-08
65599	SUPPL	2020-12-16
64743	SUPPL	2020-09-29
64725	SUPPL	2020-09-29
61384	SUPPL	2019-12-23
61343	SUPPL	2019-12-19
58679	SUPPL	2019-05-14
58658	SUPPL	2019-05-13
55489	SUPPL	2018-10-29
55488	SUPPL	2018-10-29
55526	SUPPL	2018-09-19
55525	SUPPL	2018-09-19
54364	SUPPL	2018-05-29
54357	SUPPL	2018-05-29
50260	SUPPL	2017-11-02
48847	SUPPL	2017-06-27
48841	SUPPL	2017-06-27
15733	SUPPL	2015-03-27
15732	SUPPL	2015-03-27
5686	SUPPL	2015-03-25
28074	SUPPL	2015-02-19
15731	SUPPL	2014-05-28
28073	SUPPL	2014-05-27
37191	SUPPL	2013-11-13
15730	SUPPL	2013-11-13
5685	SUPPL	2013-11-12
5684	SUPPL	2013-11-12
5683	SUPPL	2012-11-06
37190	SUPPL	2012-11-02
37189	SUPPL	2012-07-30
37188	SUPPL	2012-07-30
28072	SUPPL	2012-07-30
28071	SUPPL	2012-07-30
28070	SUPPL	2010-02-23
15729	SUPPL	2010-02-23
28069	SUPPL	2009-11-24
15728	SUPPL	2009-07-23
28068	SUPPL	2008-06-02
37187	SUPPL	2007-09-26
37186	SUPPL	2007-09-26
28067	SUPPL	2007-09-25
28066	SUPPL	2007-09-25
28064	SUPPL	2006-09-18
15727	SUPPL	2006-08-29
28065	SUPPL	2006-04-20
37185	SUPPL	2006-04-14
37184	SUPPL	2004-09-29
28063	SUPPL	2004-09-29
21726	ORIG	2004-08-05
37183	ORIG	2004-02-03
28062	ORIG	2004-02-03

Application 021540

Related Records#

Application Products#

NDC Listings For This Application#

Documents#