Application 088588

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE INTENSOL	HYDROCHLOROTHIAZIDE	SOLUTION;ORAL	100MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	HYDROCHLOROTHIAZIDE	100MG/ML	SOLUTION / ORAL			1984-07-02

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088588-001	HYDROCHLOROTHIAZIDE INTENSOL	100MG/ML	SOLUTION / ORAL	1984-07-02	`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 7 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	34703033-14c4-459c-8b8f-2f2e1145aff7	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	98edae8a-99dc-4f26-a956-3ad58bf38a26	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	48b4d633-ecfa-4748-80e8-6c0e3d8b067e	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	fd9b3e5a-f564-4730-8b9f-2cdc2953cbc9	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	b54ec2b1-3325-46a1-b654-8a75dc41ab0a	2022-03-01	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	4c3403a6-da6a-4f37-bc7e-9fe0aa284305	2021-12-07	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	f0b993f2-9771-42e3-b10e-09719189e2bd	2021-01-19	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	6be05675-c4b4-4e1e-9047-044a7fc7cef6	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	78c04f59-65c3-4a16-83a6-ed4a409afce5	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	e8ca7334-4b58-4f4b-bf36-0ab47b60ff7c	2020-12-14	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	ec70ea28-a219-45d1-9d5b-6a79c7ef4987	2020-10-28	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	841b7962-bf5d-4c45-b594-80b17ba5187d	2020-09-11	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	0fdb6713-8013-4cfe-a776-0c1e9414a91c	2020-06-02	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Solco Healthcare U.S., LLC	60c97ab9-b25e-4ea5-a159-792292178c65	2020-05-20	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	ScieGen Pharmaceuticals, Inc.	02e96a51-1d56-460c-8c20-3d6f37e0ce46	2020-05-11	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Exelan Pharmaceuticals Inc.	b5a1b38c-0433-4649-a8b0-f72db0a96c45	2018-12-28	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	0f7a608d-748b-49a9-a4b3-b3fdcab53ce0	2017-12-21	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	61487122-8a94-4ad5-a307-7893e0b7510c	2017-10-13	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	2febae4f-836e-4935-bd06-3495f87b3b82	2017-08-15	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.