Application 202910

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRBESARTAN	IRBESARTAN	TABLET;ORAL	75MG	No	No
002	IRBESARTAN	IRBESARTAN	TABLET;ORAL	150MG	No	No
003	IRBESARTAN	IRBESARTAN	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202910-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27
A202910-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27
A202910-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202910-001	AB
A202910-002	AB
A202910-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202910-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202910-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202910-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202910-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202910-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202910-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202910-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202910-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202910-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202910-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202910-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202910-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202910-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202910-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202910-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202910-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202910-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202910-001	AB	1	`8072bd15b7f6…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	5b259fdd-ca4c-49c9-a50d-86066f5b0746	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 70518-2685
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	7e0ddb7b-80c5-47ab-afee-c74bb735e829	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 71335-1547 ndc (product): 71335-1244
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	21dd9a41-93c7-470c-94ed-f4c24e3d5633	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 71335-1826
Irbesartan	IRBESARTAN	Preferred Pharmaceuticals Inc.	197871da-e0c5-49a9-8dd0-34a8c2685c6b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	0c1fc197-c2d9-453c-b79f-b53de89c188b	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 70518-2245
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	bb58acb0-2dc0-45ee-86bb-b405b1b75cff	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 70518-2246
Irbesartan	IRBESARTAN	Camber Pharmaceuticals, Inc.	33416f1e-adee-4a45-b6fe-1fc39044e307	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 31722-729 ndc (product): 31722-730 ndc (product): 31722-731
Irbesartan	IRBESARTAN	AvPAK	61b60f94-35e6-b90b-08ce-fbb2fe011f34	2025-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 50268-442 ndc (product): 50268-440 ndc (product): 50268-441
IRBESARTAN	IRBESARTAN	direct rx	bfdf76ae-fedf-630c-e053-2995a90a9868	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 72189-270 ndc (product): 72189-205 ndc (product): 72189-201
Irbesartan	IRBESARTAN	Quality Care Products, LLC	9b8581c1-d052-4fe2-a9fc-cf7adf0f9061	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	5c125c2a-a709-4cf1-b2d5-6e1d24a77377	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	A-S Medication Solutions	9644fa38-dd28-4888-9d55-80967c4fc8d7	2023-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910
Irbesartan	IRBESARTAN	A-S Medication Solutions	868bd0a7-38ff-4722-8063-a697af3be527	2023-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 50090-2017 ndc (product): 50090-1284
Irbesartan	IRBESARTAN	Proficient Rx LP	950e33da-5e77-40df-b73b-dd084b36a804	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202910 application number: ANDA202910 ndc (product): 71205-452

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-729	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-729	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-730	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-730	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-731	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-731	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-1284	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50090-1284	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50090-2017	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50090-2017	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50090-2017	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50090-2017	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50090-2017	Irbesartan	Irbesartan	A-S Medication Solutions	ANDA	Current
50268-440	Irbesartan	Irbesartan	AvPAK	ANDA	Current
50268-441	Irbesartan	Irbesartan	AvPAK	ANDA	Current
50268-441	Irbesartan	Irbesartan	AvPAK	ANDA	Current
50268-442	Irbesartan	Irbesartan	AvPAK	ANDA	Current
50268-442	Irbesartan	Irbesartan	AvPAK	ANDA	Current
68084-217	Irbesartan	Irbesartan	American Health Packaging	ANDA	Current
70518-1798	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2245	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2245	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2245	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2245	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2246	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2246	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2685	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2685	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
70518-2685	Irbesartan	Irbesartan	REMEDYREPACK INC.	ANDA	Current
71205-452	Irbesartan	Irbesartan	Proficient Rx LP	ANDA	Current
71205-452	Irbesartan	Irbesartan	Proficient Rx LP	ANDA	Current
71335-1244	Irbesartan	Irbesartan	Bryant Ranch Prepack	ANDA	Current
71335-1244	Irbesartan	Irbesartan	Bryant Ranch Prepack	ANDA	Current
71335-1547	Irbesartan	Irbesartan	Bryant Ranch Prepack	ANDA	Current
71335-1826	Irbesartan	Irbesartan	Bryant Ranch Prepack	ANDA	Current
72189-201	IRBESARTAN	IRBESARTAN	direct rx	ANDA	Current
72189-201	IRBESARTAN	IRBESARTAN	direct rx	ANDA	Current
72189-201	IRBESARTAN	IRBESARTAN	direct rx	ANDA	Current
72189-205	IRBESARTAN	IRBESARTAN	direct rx	ANDA	Current
72189-205	IRBESARTAN	IRBESARTAN	direct rx	ANDA	Current
72189-270	IRBESARTAN	IRBESARTAN	direct rx	ANDA	Current