Application 209281

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	12.5MG;20MG	No	No
002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	12.5MG;40MG	No	No
003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	TABLET;ORAL	25MG;40MG	No	No

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

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
A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07
A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07
A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	2019-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209281-001	AB
A209281-002	AB
A209281-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209281-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2019-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209281-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2019-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209281-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2019-02-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209281-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209281-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209281-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209281-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209281-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209281-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209281-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209281-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209281-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209281-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209281-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209281-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209281-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209281-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209281-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209281-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209281-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209281-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209281-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209281-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209281-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209281-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209281-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209281-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209281-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209281-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209281-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209281-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209281-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209281-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209281-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209281-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A209281-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A209281-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209281-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209281-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209281-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209281-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209281-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209281-003	AB	1	`a50c72e98297…`

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
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	d858a6de-dda5-4bcd-a255-5723d01d896f	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209281 application number: ANDA209281 ndc (product): 16729-367 ndc (product): 16729-366 ndc (product): 16729-368
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3df6c955-9c38-4e44-a665-dac2a051bd02	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209281 application number: ANDA209281 ndc (product): 50090-5402

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-366	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-366	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-367	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-367	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-367	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-368	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-368	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
16729-368	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	ANDA	Current
50090-5402	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ANDA	Current
50090-5402	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ANDA	Current