Application 209010

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

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

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

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	Approval date
A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03
A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03
A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03
A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209010-001	AB
A209010-002	AB
A209010-003	AB
A209010-004	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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209010-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209010-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209010-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2018-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209010-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2018-12-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209010-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209010-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209010-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209010-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209010-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209010-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209010-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209010-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209010-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209010-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209010-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209010-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209010-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209010-004	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A209010-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209010-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209010-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209010-004	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A209010-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209010-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209010-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209010-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209010-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209010-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209010-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209010-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209010-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209010-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209010-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209010-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209010-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209010-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209010-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209010-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209010-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209010-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209010-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209010-004	AB	1	`c0c555d07b60…`

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
Amlodipine and Olmesartan Medoxomil	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AvKARE	1b30c3fe-5c84-0d42-e063-6394a90a81d8	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209010 application number: ANDA209010
Amlodipine and Olmesartan Medoxomil	AMLODIPINE AND OLMESARTAN MEDOXOMIL	ScieGen Pharmaceuticals, Inc	c531fceb-09aa-492b-a5a3-2b004e9eadda	2024-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209010 application number: ANDA209010 ndc (product): 50228-365 ndc (product): 50228-367 ndc (product): 50228-366 ndc (product): 50228-368
Amlodipine and Olmesartan Medoxomil	AMLODIPINE AND OLMESARTAN MEDOXOMIL	Amneal Pharmaceuticals NY LLC	02f9b562-6f7f-4783-bb0d-67c318073e1c	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209010 application number: ANDA209010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-365	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-366	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-367	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-368	Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	ScieGen Pharmaceuticals, Inc	ANDA	Current