Application 022100

Type: NDA
Sponsor: DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;20MG	Yes	No
002	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 5MG BASE;40MG	Yes	No
003	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;20MG	Yes	No
004	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	EQ 10MG BASE;40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022100-001	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26
N022100-002	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26
N022100-003	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26
N022100-004	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022100-001	AB
N022100-002	AB
N022100-003	AB
N022100-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022100-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022100-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022100-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022100-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022100-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022100-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022100-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022100-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022100-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022100-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022100-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022100-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022100-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022100-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022100-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022100-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022100-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022100-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022100-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022100-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022100-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022100-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022100-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022100-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022100-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022100-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022100-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022100-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022100-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022100-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022100-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022100-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022100-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022100-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022100-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022100-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022100-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022100-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022100-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022100-004	AB	1	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amlodipine besylate and olmesartan medoxomil	AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL	Golden State Medical Supply, Inc.	132cca8f-48a2-2516-e063-6394a90a5f32	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022100 application number: NDA022100
Azor	AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	c5535406-b63b-49aa-88b9-169aaf0ed08e	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022100 application number: NDA022100 ndc (product): 0713-0872 ndc (product): 0713-0871 ndc (product): 0713-0873 ndc (product): 0713-0870

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0870	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0870	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0870	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0871	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0871	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0871	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0872	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0872	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0872	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0873	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0873	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0873	Azor	amlodipine besylate and olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
57664-772	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-772	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-772	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-772	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-772	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-773	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-773	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-773	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-773	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-773	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-774	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-774	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-774	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-774	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-774	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-775	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-775	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-775	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-775	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-775	Amlodipine and Olmesartan Medoxomil	amlodipine besylate and olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
65597-110	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-110	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-110	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-110	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-110	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-110	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-111	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-111	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-111	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-111	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-111	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-111	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-112	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-112	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-112	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-112	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-112	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-112	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-113	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-113	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-113	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-113	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-113	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-113	Azor	amlodipine besylate and olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64874	SUPPL	2020-10-07
64819	SUPPL	2020-10-05
46836	SUPPL	2017-01-13
46723	SUPPL	2017-01-06
46132	SUPPL	2016-12-13
45779	SUPPL	2016-11-02
45775	SUPPL	2016-11-01
16929	SUPPL	2014-09-26
6875	SUPPL	2014-09-24
38230	SUPPL	2014-07-03
6874	SUPPL	2014-07-03
6873	SUPPL	2014-06-18
38229	SUPPL	2014-06-17
38228	SUPPL	2013-07-05
6872	SUPPL	2013-07-05
38227	SUPPL	2012-12-13
6871	SUPPL	2012-12-11
29235	SUPPL	2012-10-03
16928	SUPPL	2012-10-02
38226	SUPPL	2012-01-23
29234	SUPPL	2012-01-20
29232	SUPPL	2011-11-16
38224	SUPPL	2011-11-14
29233	SUPPL	2011-11-03
38225	SUPPL	2011-10-31
6870	SUPPL	2011-05-24
6869	SUPPL	2011-05-24
38223	SUPPL	2011-05-23
16927	SUPPL	2011-05-23
21935	ORIG	2009-12-17
29230	SUPPL	2009-05-14
38222	SUPPL	2009-05-13
29231	SUPPL	2008-08-12
38221	ORIG	2007-10-04
6868	ORIG	2007-10-04