Application 208803

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EZETIMIBE	EZETIMIBE	TABLET;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208803-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208803-001	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 2 · 41 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	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208803-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A208803-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208803-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208803-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208803-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208803-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208803-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208803-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208803-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208803-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208803-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208803-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208803-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208803-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208803-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208803-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208803-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208803-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208803-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208803-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208803-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208803-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208803-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208803-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208803-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208803-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208803-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208803-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208803-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208803-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208803-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208803-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208803-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208803-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208803-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208803-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208803-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208803-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208803-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208803-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208803-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	AvPAK	6fcbfbd9-6e09-8224-e053-2a91aa0a8226	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208803 application number: ANDA208803 ndc (product): 50268-298
Ezetimibe	EZETIMIBE	Amneal Pharmaceuticals NY LLC	3fadf4e9-017d-4ccd-91dc-a89b981eb138	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208803 application number: ANDA208803 ndc (product): 69238-1154
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	d6b4fd12-9954-42ba-b42a-56f3747c47ff	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208803 application number: ANDA208803 ndc (product): 71335-0684

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3087	Ezetimibe	Ezetimibe	A-S Medication Solutions	ANDA	Current
50268-298	Ezetimibe	Ezetimibe	AvPAK	ANDA	Current
50268-298	Ezetimibe	Ezetimibe	AvPAK	ANDA	Current
69238-1154	Ezetimibe	Ezetimibe	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1154	Ezetimibe	Ezetimibe	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1154	Ezetimibe	Ezetimibe	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1154	Ezetimibe	Ezetimibe	Amneal Pharmaceuticals LL	ANDA	Current
69238-1154	Ezetimibe	Ezetimibe	Amneal Pharmaceuticals NY LLC	ANDA	Current
71335-0684	Ezetimibe	Ezetimibe	Bryant Ranch Prepack	ANDA	Current