Application 076674

Type: ANDA
Sponsor: COREPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;10MG	No	No
002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;20MG	No	No
003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	25MG;20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076674-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET / ORAL	AB	2004-10-05
A076674-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2004-10-05
A076674-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2004-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076674-001	AB
A076674-002	AB
A076674-003	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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	A076674-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL		2004-10-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076674-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL		2004-10-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076674-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL		2004-10-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076674-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL		2004-10-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076674-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL		2004-10-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076674-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL		2004-10-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076674-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL		2004-10-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076674-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL		2004-10-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076674-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL		2004-10-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076674-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2004-10-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076674-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2004-10-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076674-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2004-10-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076674-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076674-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076674-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076674-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076674-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076674-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076674-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076674-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076674-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076674-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076674-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076674-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076674-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076674-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076674-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076674-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076674-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076674-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076674-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076674-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076674-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076674-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076674-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076674-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076674-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076674-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076674-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076674-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076674-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076674-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076674-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076674-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076674-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076674-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076674-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076674-003	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076674-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076674-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076674-003	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL and HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	GSMS, Incorporated	d02a0d38-676a-4e0f-9aa2-0a6c56cd7361	2025-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076674 application number: ANDA076674

Reported adverse events (FAERS/openFDA)#

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