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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`84e616aacf4f…`
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…`

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 6 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	ff448eb4-b48f-46f5-ac30-f03aad08f9f5	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	78d65a02-c78e-4f98-b756-3cb5ee78f252	2024-02-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	bd5728a2-6322-42e3-bd1e-e4915750e398	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	01ad3531-5ed9-434c-b7d5-02d72aa82e46	2023-12-25	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5de62aee-f3cc-4aaa-8588-2aed2bdeced9	2023-11-14	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	94cd40a1-65bc-4b1b-bb05-cec93bc96502	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	d6b933c6-f5f8-406a-84d6-b22c6040482a	2023-10-19	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	24cba606-263f-46dc-a4dc-fddc729c0f4b	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	9dd2f58b-d143-4d0c-a298-6d9390e6187a	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b9e1bed7-fef9-434a-92f9-b70941176e3e	2023-09-11	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	1bb00980-eeea-4722-b010-e208f3ec2214	2023-08-24	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b56a3559-6eb2-4a8d-a9a4-232d2ff0febe	2023-06-29	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	460f922c-1fda-44a5-889e-d7009883176b	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5605f105-f7ec-473f-8beb-9e8955e8e26e	2023-04-28	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	69c41abb-75f4-429b-905a-1ce967924aee	2023-04-04	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Proficient Rx LP	3464be28-5bab-4642-9d9b-8b425822dd07	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Actavis Pharma, Inc.	afdf1170-25a0-496d-b293-36ee0db2cd1e	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	54224596-325d-473e-adb5-1c86857aba34	2023-02-04	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	c1052d38-fd75-40c2-a685-0e889009be0b	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	c4fe84e3-c291-4220-95c1-a2bd02b1e134	2023-02-01	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.

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