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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021540-001	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-002	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-003	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-004	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-005	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-006	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-007	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30
N021540-008	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30
N021540-009	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29
N021540-010	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29
N021540-011	CADUET	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 11 matching rows.

Application-product, TE code table
Application-product	TE code
N021540-001	AB
N021540-002	AB
N021540-003	AB
N021540-004	AB
N021540-005	AB
N021540-006	AB
N021540-007	AB
N021540-008	AB
N021540-009	AB
N021540-010	AB
N021540-011	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N021540-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-008	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-009	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-010	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021540-011	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caduet	AMLODIPINE AND ATORVASTATIN	Pfizer Laboratories Div Pfizer Inc	6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021540 application number: NDA021540 ndc (product): 0069-2150 ndc (product): 0069-2260 ndc (product): 0069-2250 ndc (product): 0069-2190 ndc (product): 0069-2160 ndc (product): 0069-2270 ndc (product): 0069-2180 ndc (product): 0069-2170
Caduet	AMLODIPINE AND ATORVASTATIN	Viatris Specialty LLC	164394b3-d7ba-4bbf-b64b-e2dd15735ea8	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021540 application number: NDA021540
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Prasco Laboratories	14124e56-77ba-426d-8f5a-dbe42eda1a20	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021540 application number: NDA021540

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 174 matching rows.

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