Application 079213

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

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 44.

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
A079213-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27
A079213-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27
A079213-003	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
A079213-001	AB
A079213-002	AB
A079213-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079213-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079213-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079213-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A079213-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079213-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079213-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079213-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079213-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079213-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079213-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079213-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079213-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079213-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079213-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079213-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079213-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079213-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079213-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079213-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079213-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079213-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079213-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079213-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079213-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079213-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079213-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079213-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079213-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079213-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079213-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079213-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079213-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079213-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079213-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079213-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079213-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079213-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079213-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079213-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079213-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079213-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079213-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079213-001	AB	1	`79d66fd596c7…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	14d85774-2d74-4300-b4bb-c2836db4d5bd	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Solco Healthcare U.S., LLC	6916c617-92d2-44f5-b968-6267517a2ce6	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	Alembic Pharmaceuticals Inc.	83f5d5c8-27c0-4208-a291-0c4aa55a1ff5	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	AvKARE	2d80abcb-c995-82bc-e063-6294a90aa530	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Unichem Pharmaceuticals (USA), Inc.	fdf196d5-e933-49de-9c4c-bde50149c7d4	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	A-S Medication Solutions	70a25c6d-23ce-488c-9ef8-62b3b99e5052	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	A-S Medication Solutions	6babdb48-8384-49ce-a759-d380d79a4010	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	direct rx	bfdf76ae-fedf-630c-e053-2995a90a9868	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Quality Care Products, LLC	9b8581c1-d052-4fe2-a9fc-cf7adf0f9061	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	ecc490ea-a68e-4261-8be2-5020ac5ab803	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	5c125c2a-a709-4cf1-b2d5-6e1d24a77377	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	A-S Medication Solutions	9644fa38-dd28-4888-9d55-80967c4fc8d7	2023-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	A-S Medication Solutions	868bd0a7-38ff-4722-8063-a697af3be527	2023-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	efcd5f2e-1837-44ae-bc91-410c4d8b27c7	2023-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	1ab1ff46-d0b1-4762-9ebf-3e07dde8b048	2023-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Lupin Pharmaceuticals, Inc.	a7c093c2-3eef-4956-8a14-c36aada0304f	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Proficient Rx LP	f0ec2ccc-7d79-4cde-a13e-08faeea4e934	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	Alembic Pharmaceuticals Limited	0898f423-0aa9-409c-8d4e-1349b59141d1	2022-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Proficient Rx LP	950e33da-5e77-40df-b73b-dd084b36a804	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	ScieGen Pharmaceuticals, Inc.	ddca7d7c-07fe-4df6-83ae-a9c05048b66e	2021-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-299	Irbesartan	Irbesartan	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-299	Irbesartan	Irbesartan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-299	Irbesartan	Irbesartan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-300	Irbesartan	Irbesartan	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-300	Irbesartan	Irbesartan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-300	Irbesartan	Irbesartan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-301	Irbesartan	Irbesartan	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-301	Irbesartan	Irbesartan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-301	Irbesartan	Irbesartan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1159	Irbesartan	Irbesartan	Zydus Lifesciences Limited	ANDA	Current
70771-1159	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1159	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1159	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1160	Irbesartan	Irbesartan	Zydus Lifesciences Limited	ANDA	Current
70771-1160	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1160	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1160	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1161	Irbesartan	Irbesartan	Zydus Lifesciences Limited	ANDA	Current
70771-1161	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1161	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current
70771-1161	Irbesartan	Irbesartan	Cadila Healthcare Limited	ANDA	Current