Application 203072

Type: ANDA
Sponsor: PRINSTON INC

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;150MG	TABLET / ORAL	AB		2014-05-09
A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	12.5MG;300MG	TABLET / ORAL	AB		2014-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203072-001	AB
A203072-002	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 · 86 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	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203072-001	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG	TABLET / ORAL	AB	2014-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203072-002	IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;300MG	TABLET / ORAL	AB	2014-05-09	`74a2ff9319b5…`

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	A203072-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203072-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203072-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203072-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203072-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203072-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203072-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203072-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203072-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203072-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203072-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203072-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203072-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203072-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203072-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203072-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203072-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203072-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203072-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203072-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203072-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203072-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203072-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203072-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203072-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203072-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203072-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203072-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203072-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	88aaa2a1-13be-4f56-ace6-66e899028007	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072 ndc (product): 70518-1550
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	85494404-484c-45a1-8487-f9eb2a76490d	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072 ndc (product): 71335-2099
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	72fa8cd4-bc2a-4a7d-8feb-2d60e077d801	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072 ndc (product): 43547-331 ndc (product): 43547-330
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	53ce6e4f-db3a-4789-8bef-1e459fa78b79	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072
Irbesartan and Hydrochlorothiazide	IRBESARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	c7ce5a69-1e07-4d52-b815-ce64ac3731ac	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203072 application number: ANDA203072 ndc (product): 71205-063

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-330	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-331	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-672	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
70518-1550	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1550	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1550	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-3593	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
71205-063	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-063	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71335-2099	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current