Application 208332

Type: ANDA
Sponsor: APOTEX

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
A208332-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL			2017-06-12

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	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208332-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A208332-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208332-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208332-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208332-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208332-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208332-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208332-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208332-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208332-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208332-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208332-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208332-001	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 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	A-S Medication Solutions	090776cf-f211-49a3-a993-ff5d707311f2	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	A-S Medication Solutions	a1cc2018-72a3-48bc-90de-c460f224cf5a	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Major Pharmaceuticals	e257ed7f-5015-4f1d-93f4-5adf5797643d	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
EZETIMIBE	EZETIMIBE	Bryant Ranch Prepack	02b00cb2-7253-4fb4-a216-53691a929a28	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: EZETIMIBE generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	AvPAK	6fcbfbd9-6e09-8224-e053-2a91aa0a8226	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Zetia	EZETIMIBE	Organon LLC	174e45e0-45bb-48b7-9e60-8f6cfc1d22bb	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Marlex Pharmaceuticals, Inc.	109a22f4-a7cb-96c6-e063-6394a90ad7f6	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
EZETIMIBE	EZETIMIBE	Accord Healthcare Inc.	ceecdbe9-5404-4a93-a488-9211cd103058	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: EZETIMIBE generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	American Health Packaging	0e9a9eda-1b2a-4475-8483-0f410a17c524	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
EZETIMIBE	EZETIMIBE	A-S Medication Solutions	4cfda5aa-e21a-47b2-b296-88d8336298ef	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: EZETIMIBE generic name: EZETIMIBE
EZETIMIBE	EZETIMIBE	A-S Medication Solutions	4158aa71-3540-4912-b909-7491e5a1429c	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: EZETIMIBE generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	A-S Medication Solutions	dd8a09cb-f014-4650-9da2-4ad1581c9741	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	c92292f5-5444-4247-927e-db7bf6816109	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Ascend Laboratories, LLC	206d702c-b09a-4555-972b-6555d6d6d6e6	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	3a80b668-51cd-42be-8497-8712b0508422	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Aurobindo Pharma Limited	726b1e63-437a-4b3b-b773-3ac47a5c0f38	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	NorthStar Rx LLC	5f5644a9-e019-4e5d-ab6f-3d30b1024c5a	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Proficient Rx LP	55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Amneal Pharmaceuticals NY LLC	3fadf4e9-017d-4ccd-91dc-a89b981eb138	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
ezetimibe	EZETIMIBE	Zydus Lifesciences Limited	de814dcd-4759-4e9c-a650-335fb885a79d	2024-11-28		Name fallback brand name: ezetimibe generic name: EZETIMIBE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6664	Ezetimibe	Ezetimibe	Major Pharmaceuticals	ANDA	Current
0904-6664	Ezetimibe	Ezetimibe	Major Pharmaceuticals	ANDA	Current
0904-6664	Ezetimibe	Ezetimibe	Major Pharmaceuticals	ANDA	Current
42291-314	Ezetimibe	Ezetimibe	AvKARE, Inc.	ANDA	Current
42291-314	Ezetimibe	Ezetimibe	AvKARE, Inc.	ANDA	Current
50090-3402	Ezetimibe	Ezetimibe	A-S Medication Solutions	ANDA	Current
60505-2945	Ezetimibe	Ezetimibe	Apotex Corp.	ANDA	Current
71335-1354	Ezetimibe	Ezetimibe	Bryant Ranch Prepack	ANDA	Current