Application 077369

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No
002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No
003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	25MG;300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30
A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30
A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET / ORAL		2012-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077369-001	AB
A077369-002	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL		2012-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077369-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-03-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077369-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077369-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077369-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077369-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077369-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077369-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077369-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077369-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077369-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077369-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077369-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077369-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077369-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077369-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077369-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077369-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077369-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077369-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077369-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077369-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077369-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077369-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077369-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077369-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077369-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077369-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077369-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077369-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077369-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077369-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077369-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077369-002	AB	1	`74a2ff9319b5…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5eabb13d-f6fd-4091-9909-c4f0c5922289	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369 ndc (product): 71335-1097
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5029c9f7-6233-4a6f-ace9-2268cc8e286d	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Teva Pharmaceuticals USA, Inc.	83f4acc1-697a-4770-b554-1b9a8fb5de74	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369 ndc (product): 0093-8238 ndc (product): 0093-8232
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	c5f26357-40f3-49f4-99f2-845a8dda5f39	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077369 application number: ANDA077369 ndc (product): 63187-981

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-342	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-342	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	AvKARE	ANDA	Current
42291-343	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	AvKARE, Inc.	ANDA	Current
42291-343	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	AvKARE	ANDA	Current
63187-981	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
63187-981	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
68645-405	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Legacy Pharmaceutical Packaging	ANDA	Current
70518-2247	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2247	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2247	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2247	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2247	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2619	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2619	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2619	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2619	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
71335-1097	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-1097	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-1097	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9039	ORIG	2012-04-02