Application 207804

Type: ANDA
Sponsor: PRINSTON INC

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
A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24
A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24
A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	2017-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207804-001	AB
A207804-002	AB
A207804-003	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	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207804-002	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207804-003	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	25MG;40MG	TABLET / ORAL	AB	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207804-001	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2017-04-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A207804-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207804-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207804-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207804-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207804-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207804-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207804-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207804-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207804-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207804-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207804-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207804-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207804-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207804-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207804-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207804-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207804-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207804-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207804-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207804-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207804-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207804-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207804-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207804-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207804-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207804-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207804-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207804-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207804-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207804-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207804-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207804-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207804-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207804-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207804-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207804-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207804-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207804-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207804-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207804-003	AB	1	`f41ea6bd6efb…`

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 · 7 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	Bryant Ranch Prepack	68d44330-4213-46a7-97b9-f858c16454d1	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	78eb9041-a738-4056-8705-8c1dd13a4da4	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	2c8bb018-af07-4745-a4e9-f9a6795a5ea2	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	bdca31d3-60b1-4659-aef7-56530b4f9039	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804 ndc (product): 43547-391 ndc (product): 43547-393 ndc (product): 43547-392
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	5c4c5907-36f0-461e-b0c9-d51edff32a97	2025-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	4c0b028d-f0f4-417f-a068-dca24e56113f	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	13a03209-c73c-4254-be19-d1f8884cc662	2023-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207804 application number: ANDA207804

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-391	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-391	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-392	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-392	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-393	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-393	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
70518-1347	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1347	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	olmesartan medoxomil and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current