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 42.

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.

Product history page 1 of 12 · 462 observed 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
2026-08-18 06:07:40	2026-07	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 12 · 462 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021540-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-009	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-010	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021540-011	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021540-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-009	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-010	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-011	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-009	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-010	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-011	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021540-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-007	AB	1	`6a471c1ec25d…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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