Application 208130

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	5MG	No	No
002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	20MG	No	No
003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	TABLET;ORAL	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208130-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29
A208130-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29
A208130-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208130-001	AB
A208130-002	AB
A208130-003	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 4 · 123 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	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208130-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208130-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208130-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208130-001	AB	1	`8072bd15b7f6…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	4a2aad53-fcba-2a61-e063-6394a90a6016	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	fe6e39da-fb6e-46da-9c03-c765020a7c87	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Golden State Medical Supply, Inc.	865c2765-5072-d029-e053-2a91aa0a098e	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 51407-197 ndc (product): 51407-199 ndc (product): 51407-198
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	8466711a-3a02-4675-96db-c7cffdb89778	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 63629-8525
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	640936ee-55a6-47ae-a1ad-cffae316b925	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 63629-8523
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	1be698df-30a0-4117-8c24-7253af94c8ad	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	25431c8c-9f6e-42e7-ab84-4b062755bfe3	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	fe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 63629-8522
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	c35408d2-a4b5-43de-8dab-f74a60fa9853	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 63629-8524
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	409e06ad-2ea9-4b47-829e-57139e22eac9	2023-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 71335-1920
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	ScieGen Pharmaceuticals, Inc.	f15664a4-6b5f-4e88-ad56-c827ed90a40c	2021-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (product): 50228-339 ndc (product): 50228-340 ndc (product): 50228-341

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-542	olmesartan medoxomil	olmesartan medoxomil	AvKARE, Inc.	ANDA	Current
42291-542	olmesartan medoxomil	olmesartan medoxomil	AvKARE	ANDA	Current
42291-543	olmesartan medoxomil	olmesartan medoxomil	AvKARE, Inc.	ANDA	Current
42291-543	olmesartan medoxomil	olmesartan medoxomil	AvKARE	ANDA	Current
42291-544	olmesartan medoxomil	olmesartan medoxomil	AvKARE, Inc.	ANDA	Current
42291-544	olmesartan medoxomil	olmesartan medoxomil	AvKARE	ANDA	Current
50228-339	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-339	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-339	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-340	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-340	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-340	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-341	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-341	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-341	olmesartan medoxomil	olmesartan medoxomil	ScieGen Pharmaceuticals, Inc.	ANDA	Current
51407-197	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply Inc	ANDA	Current
51407-197	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply	ANDA	Current
51407-197	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply, Inc.	ANDA	Current
51407-198	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply Inc	ANDA	Current
51407-198	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply	ANDA	Current
51407-198	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply, Inc.	ANDA	Current
51407-199	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply Inc	ANDA	Current
51407-199	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply	ANDA	Current
51407-199	olmesartan medoxomil	olmesartan medoxomil	Golden State Medical Supply, Inc.	ANDA	Current
63629-8522	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8522	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8523	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8523	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8524	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8524	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8525	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
63629-8525	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-1920	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current