Application 090201

Type: ANDA
Sponsor: HIKMA

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	Approval date
A090201-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15
A090201-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15
A090201-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090201-002	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090201-003	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090201-001	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090201-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090201-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090201-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090201-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090201-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090201-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090201-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090201-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090201-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090201-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090201-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090201-003	AB	1	`ea99ee380514…`

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	Macleods Pharmaceuticals Limited	e8635a1c-ae06-4e23-99f7-e704f91d6f43	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	Hisun Pharmaceuticals USA Inc.	61ab1b6e-c849-49ca-a3f0-150774db649d	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	5b259fdd-ca4c-49c9-a50d-86066f5b0746	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	029a90b6-0722-49be-8400-3ec29526aafd	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	9adacfa2-2814-4deb-9e34-c3b3c8dcd41a	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	Chartwell RX, LLC	6eb0cb56-2e51-45ef-9fd5-5646cf9f78a3	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	7e0ddb7b-80c5-47ab-afee-c74bb735e829	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	21dd9a41-93c7-470c-94ed-f4c24e3d5633	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Preferred Pharmaceuticals Inc.	197871da-e0c5-49a9-8dd0-34a8c2685c6b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
IRBESARTAN	IRBESARTAN	Jubilant Cadista Pharmaceuticals Inc.	068224c4-a34d-32d7-bb2a-7eed44ccf7d3	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IRBESARTAN generic name: IRBESARTAN
Irbesartan	IRBESARTAN	NorthStar RxLLC	08c85ada-de6f-4cff-bc81-2332a22bef45	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	0c1fc197-c2d9-453c-b79f-b53de89c188b	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	REMEDYREPACK INC.	bb58acb0-2dc0-45ee-86bb-b405b1b75cff	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Camber Pharmaceuticals, Inc.	33416f1e-adee-4a45-b6fe-1fc39044e307	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Avapro	IRBESARTAN	Sanofi-Aventis U.S. LLC	7885b2a8-be4e-48ab-8113-4e6ab791eb98	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Aurobindo Pharma Limited	2113a901-2612-4557-b86d-3afc006fb8bb	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	bc07bbf5-b1c6-4854-b6af-e06520c20728	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Amneal Pharmaceuticals LLC	8c9bb449-6341-4f24-9d38-6ca952e07122	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	ed789dc1-0b39-4efc-990d-7b6b43a8b3ba	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Bryant Ranch Prepack	44b72da1-4434-461f-8e3c-264ad46f85df	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0250	Irbesartan	Irbesartan	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0251	Irbesartan	Irbesartan	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0252	Irbesartan	Irbesartan	West-Ward Pharmaceuticals Corp.	ANDA	Current