Application 204774

Type: ANDA
Sponsor: SCIEGEN PHARMS 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 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
A204774-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07
A204774-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07
A204774-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204774-001	AB
A204774-002	AB
A204774-003	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	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204774-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2015-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204774-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2015-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204774-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2015-12-07	`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	A204774-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204774-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204774-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204774-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204774-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204774-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204774-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204774-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204774-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204774-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204774-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204774-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204774-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204774-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204774-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204774-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204774-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204774-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204774-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204774-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204774-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204774-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204774-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204774-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204774-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204774-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204774-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204774-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204774-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204774-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204774-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204774-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204774-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204774-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204774-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204774-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204774-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204774-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204774-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204774-001	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 · 2 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	Exact identifier application applno (ANDA): 204774 application number: ANDA204774 ndc (product): 50228-162 ndc (product): 50228-160 ndc (product): 50228-161
Irbesartan	IRBESARTAN	Camber Pharmaceuticals, Inc.	0f3408b4-44be-4a92-a59f-9b5a9716bc9a	2016-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204774 application number: ANDA204774 ndc (product): 31722-160 ndc (product): 31722-161 ndc (product): 31722-162

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-160	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-161	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-162	Irbesartan	Irbesartan	Camber Pharmaceuticals, Inc.	ANDA	Current
50228-160	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-160	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-160	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-161	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-161	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-161	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-162	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-162	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-162	Irbesartan	Irbesartan	ScieGen Pharmaceuticals, Inc.	ANDA	Current
60429-640	Irbesartan	Irbesartan	Golden State Medical Supply, Inc.	ANDA	Current
60429-640	Irbesartan	Irbesartan	Golden State Medical Supply	ANDA	Current
60429-641	Irbesartan	Irbesartan	Golden State Medical Supply, Inc.	ANDA	Current
60429-641	Irbesartan	Irbesartan	Golden State Medical Supply	ANDA	Current
60429-642	Irbesartan	Irbesartan	Golden State Medical Supply, Inc.	ANDA	Current
60429-642	Irbesartan	Irbesartan	Golden State Medical Supply	ANDA	Current
69367-119	Irbesartan	Irbesartan	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-119	Irbesartan	Irbesartan	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-120	Irbesartan	Irbesartan	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-120	Irbesartan	Irbesartan	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-121	Irbesartan	Irbesartan	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-121	Irbesartan	Irbesartan	Westminster Pharmaceuticals, LLC	ANDA	Current