Application 203281

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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
A203281-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25
A203281-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25
A203281-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203281-001	AB
A203281-002	AB
A203281-003	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	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`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	A203281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203281-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	5972c6fd-08e3-4189-a894-1ba220b57e80	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	57dc737b-01e2-4b22-991f-d4710950dcf3	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	67aa498d-edf6-45b8-a3fd-019c3fb76960	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281 ndc (product): 50090-4451
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	8acdc142-aa38-4fcb-bd15-fbba9635a4c6	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Glenmark Pharmaceuticals Inc., USA	8e0adf3d-7569-4909-bab1-5fed9578ad77	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281 ndc (product): 68462-438 ndc (product): 68462-436 ndc (product): 68462-437

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4451	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
50090-4451	Olmesartan Medoxomil	Olmesartan Medoxomil	A-S Medication Solutions	ANDA	Current
60505-4652	Olmesartan Medoxomil	Olmesartan Medoxomil	Apotex Corp.	ANDA	Current
60505-4652	Olmesartan Medoxomil	Olmesartan Medoxomil	Apotex Corp.	ANDA	Current
60505-4653	olmesartan medoxomil	olmesartan medoxomil	Apotex Corp.	ANDA	Current
60505-4653	olmesartan medoxomil	olmesartan medoxomil	Apotex Corp.	ANDA	Current
60505-4654	olmesartan medoxomil	olmesartan medoxomil	Apotex Corp.	ANDA	Current
60505-4654	olmesartan medoxomil	olmesartan medoxomil	Apotex Corp.	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-436	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-437	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-438	Olmesartan Medoxomil	Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
71335-0999	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current
71335-0999	olmesartan medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	ANDA	Current