Application 202414

Type: ANDA
Sponsor: MACLEODS 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; HYDROCHLOROTHIAZIDE	IRBESARTAN: HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB		2012-09-27
A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB		2012-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202414-001	AB
A202414-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202414-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202414-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202414-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202414-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202414-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202414-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202414-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202414-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202414-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202414-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202414-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202414-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202414-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202414-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202414-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202414-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202414-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202414-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202414-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202414-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202414-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202414-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202414-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202414-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202414-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202414-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202414-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202414-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202414-002	AB	1	`bb7c543d1eb4…`

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
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	46d77ed8-ece2-4f51-b1a4-4a440e2dce2d	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202414 application number: ANDA202414 ndc (product): 63629-7468
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	1898f438-4571-4aab-ae06-9bf1aabf0486	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202414 application number: ANDA202414 ndc (product): 33342-057 ndc (product): 33342-058
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	97b09783-7bba-4f7a-b1b3-86ccf12c7ecc	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202414 application number: ANDA202414 ndc (product): 63187-653

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-057	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-057	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-057	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-057	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-057	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-057	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-058	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-058	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-058	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-058	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-058	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-058	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
63187-653	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
63187-653	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
63629-7468	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-7468	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-7468	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
63629-7468	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
68071-2123	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-1330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current