Application 091370

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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
A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15
A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15
A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET / ORAL	AB	2016-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091370-001	AB
A091370-002	AB
A091370-003	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 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	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091370-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091370-003	IRBESARTAN AND HYDROCHLOROTHIAZIDE	25MG;300MG	TABLET / ORAL	AB	2016-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091370-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A091370-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091370-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091370-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091370-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091370-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091370-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091370-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091370-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091370-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091370-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091370-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091370-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091370-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091370-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091370-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091370-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091370-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091370-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091370-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091370-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091370-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091370-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091370-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091370-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091370-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091370-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091370-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091370-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091370-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091370-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091370-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091370-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091370-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091370-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091370-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091370-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091370-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091370-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091370-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091370-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	e842fa14-b18e-4463-9bf1-a1c8700fe33c	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091370 application number: ANDA091370 ndc (product): 62332-051 ndc (product): 62332-053 ndc (product): 62332-052
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	9492a1cd-c012-4b43-931d-235220065e1e	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091370 application number: ANDA091370 ndc (product): 46708-442 ndc (product): 46708-444 ndc (product): 46708-443

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-442	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-442	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-443	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-443	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-444	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-444	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Limited	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals I	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-051	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals I	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-052	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals I	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-053	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Alembic Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45550	ORIG	2016-10-14