Application 088587

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	SOLUTION;ORAL	50MG/5ML	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
A088587-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1984-07-02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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL		1984-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1984-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	1984-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088587-001	HYDROCHLOROTHIAZIDE	50MG/5ML	SOLUTION / ORAL	RLD	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 3 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	ab8115a0-e96f-7aee-e053-2995a90a6ec0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f3191ca2-4dbc-01f5-e053-2a95a90a572c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	e3afa83d-c79c-848a-e053-2a95a90ac922	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f331769a-ff11-6c68-e053-2a95a90a493b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f2f3b60a-bffe-2675-e053-2995a90ae96e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f7091c54-0984-7f6e-e053-6394a90afb4d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f68d211d-d802-6c78-e053-2995a90a90d7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	076017ce-8aad-1336-e063-6394a90a76b5	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f9faec8a-2b71-47bb-a296-48ecbce9af50	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	c9c44c37-bb49-4364-9293-3c8fd51b759e	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
INZIRQO	HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	41aaea48-6c1b-42c8-a96f-5923d49dc934	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	9cd5d16e-3db7-4b25-847d-6de91543463b	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Chartwell RX, LLC	4e43dd27-3f4b-4205-a26e-6ecaa8281347	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma Inc	578f74ea-53d1-4c44-b872-66033292abe0	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	5bacc909-6b02-4815-85ef-55fd25b1b1f7	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	QPharma Inc	f795db5e-d5ef-4a20-e053-6394a90a7fda	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	0937d511-4d5e-4aba-bfae-92094c67bcf4	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	c182b6a9-1a31-45ee-9cea-a557c99f5db7	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ef8a7dee-3704-4c62-8981-f8adfb47f5d0	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	67c48f86-f412-4957-8e15-aec89e07d295	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE

Reported adverse events (FAERS/openFDA)#

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