Application 203161

Type: ANDA
Sponsor: NEOPHARMA

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 43.

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
A203161-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27
A203161-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27
A203161-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203161-002	IRBESARTAN	150MG	TABLET / ORAL	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203161-003	IRBESARTAN	300MG	TABLET / ORAL	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203161-001	IRBESARTAN	75MG	TABLET / ORAL	2012-09-27	`301d65b070ca…`

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	A203161-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203161-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203161-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A203161-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203161-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203161-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203161-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203161-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203161-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203161-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203161-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203161-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203161-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203161-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203161-003	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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Irbesartan	IRBESARTAN	Proficient Rx LP	ada35ec2-8472-411a-8e7c-ff1a0df94ab5	2020-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Proficient Rx LP	b587d89b-8ff9-4180-b31a-bbff5d365a1d	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Irbesartan generic name: IRBESARTAN
Irbesartan	IRBESARTAN	Camber Pharmaceuticals, Inc.	0f3408b4-44be-4a92-a59f-9b5a9716bc9a	2016-10-06	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.