Application 040707

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040707-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2007-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040707-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040707-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040707-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040707-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040707-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040707-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040707-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040707-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040707-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040707-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040707-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040707-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040707-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040707-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040707-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040707-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040707-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040707-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040707-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040707-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040707-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040707-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040707-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040707-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040707-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040707-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040707-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040707-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040707-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040707-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040707-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040707-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040707-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040707-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040707-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040707-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040707-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040707-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040707-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040707-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040707-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040707-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	fea5a353-9b13-9b87-e053-6394a90a627d	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040707 application number: ANDA040707
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	01ad3531-5ed9-434c-b7d5-02d72aa82e46	2023-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040707 application number: ANDA040707
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Actavis Pharma, Inc.	afdf1170-25a0-496d-b293-36ee0db2cd1e	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040707 application number: ANDA040707 ndc (product): 0228-2820

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2820	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0228-2820	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0228-2820	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0228-2820	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
0228-2820	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	ANDA	Current
21695-537	Hydrochlorothiazide	Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
51138-038	Hydrochlorothiazide	Hydrochlorothiazide	Med-Health Pharma, LLC	ANDA	Current
53002-1702	Hydrochlorothiazide	Hydrochlorothiazide	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1702	Hydrochlorothiazide	Hydrochlorothiazide	RPK Pharmaceuticals, Inc.	ANDA	Current
60429-888	Hydrochlorothiazide	Hydrochlorothiazide	Golden State Medical Supply, Inc.	ANDA	Current
60429-888	Hydrochlorothiazide	Hydrochlorothiazide	Golden State Medical Supply	ANDA	Current
60429-888	Hydrochlorothiazide	Hydrochlorothiazide	Golden State Medical Supply	ANDA	Current
71610-276	Hydrochlorothiazide	Hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current