Application 084878

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	50MG	No	No
002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084878-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982
A084878-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A084878-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A084878-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084878-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084878-001	AB	1	`ea99ee380514…`

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 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	31a3d1cb-0f52-4818-965d-7584374bb23e	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	0789baef-3424-43ab-a3fb-4908172da565	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Redpharm Drug	57436cfa-9b94-89bf-e063-6394a90aa264	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	03b7e52e-0003-47c3-af12-93ef00800b37	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	cb7b7315-0170-492c-803f-60a6e75e55da	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Golden State Medical Supply, Inc.	a85f69f5-ba97-478d-e053-2a95a90a0a97	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Unit Dose Solutions, Inc.	54f027ea-0a6e-7920-e063-6394a90ab6ae	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	8a1de4e2-3aca-a4d3-e053-2995a90a1a41	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Leading Pharma, LLC	8c868894-667e-4a51-906a-838d63e420ba	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	099496f1-4e2d-8d21-e063-6294a90af695	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	a013211e-b8f8-426d-8e55-e86193f0634e	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f22a10a2-8f84-4060-9143-427237c51280	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	2b21f3fc-4164-401a-803e-b982dea97e19	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	27a7e751-8aca-440e-95e4-cfecae1a2465	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	5ab641d8-cd22-4368-8070-18487dd801eb	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	99f45e08-897d-44dd-b48d-aa6d78981f0c	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	918391e3-e8b3-4ceb-b4e7-c7c9617ea882	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	2fd8f595-7aec-4308-bb17-a6f2e7190044	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	ff557069-f177-4e2e-91f4-675a033e2739	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	c8de63da-b6c0-42f0-9d47-e273fe93adb3	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE

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
0143-1256	Hydrochlorothiazide	Hydrochlorothiazide	West-ward Pharmaceutical Corp	ANDA	Current
0143-1257	Hydrochlorothiazide	Hydrochlorothiazide	West-ward Pharmaceutical Corp	ANDA	Current
21695-538	Hydrochlorothiazide	Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
21695-539	Hydrochlorothiazide	Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
53808-0266	Hydrochlorothiazide	Hydrochlorothiazide	State of Florida DOH Central Pharmacy	ANDA	Current
55289-136	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
67046-271	Hydrochlorothiazide	Hydrochlorothiazide	Contract Pharmacy Services-PA	ANDA	Current
67046-272	Hydrochlorothiazide	Hydrochlorothiazide	Contract Pharmacy Services-PA	ANDA	Current