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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208332-001	EZETIMIBE	10MG	TABLET / ORAL		2017-06-12	`caaa826d4ba7…`
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…`

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	A-S Medication Solutions	5877150f-2807-435e-8e5b-a07dc7dbfd27	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	A-S Medication Solutions	1afdb764-c5da-4982-beae-9be61bdcbcdc	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	A-S Medication Solutions	63ecbbf1-a6de-493f-9710-812ff45cb4d3	2024-09-29	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Glenmark Pharmaceuticals Inc., USA	ac539a72-77e4-419c-b1d9-42002e9cecf7	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
EZETIMIBE	EZETIMIBE	Camber Pharmaceuticals, Inc.	c07fe2e0-dad4-48b5-8a07-7d57a4035ccd	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: EZETIMIBE generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	d6b4fd12-9954-42ba-b42a-56f3747c47ff	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	ScieGen Pharmaceuticals Inc	11de499b-ad8a-46a6-9021-c8eba72ae414	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Macleods Pharmaceuticals Limited	ebe3fa4e-82c4-4a9a-9aec-f64019391f4e	2024-05-13	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Orient Pharma Co., Ltd.	b6e77d9b-a553-63e0-e053-2a95a90a18fe	2024-04-15	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	11828685-dc27-42d8-a6ff-f110018207d1	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	03609879-bad2-4e75-83fe-1e1a2fd300c3	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Golden State Medical Supply, Inc.	4a78aa8d-1fe0-4df0-a15b-2350c15aead1	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
ezetimibe	EZETIMIBE	Quallent Pharmaceuticals Health LLC	68247ce8-e812-42f2-a3ba-0f6e49acca63	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Ohm Laboratories Inc.	5b3842f6-c80a-47b8-8a82-b69e465b05f7	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
ezetimibe	EZETIMIBE	Zydus Pharmaceuticals USA Inc.	f852b12f-e25f-415b-b1e2-58955d609507	2024-02-27	Warnings, Adverse reactions	Name fallback brand name: ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	A-S Medication Solutions	57d19491-cba1-4720-b69d-481574459201	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Proficient Rx LP	8b128e52-5d0d-4536-aa1f-be192d0989ad	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	A-S Medication Solutions	9a04678f-e961-45aa-b3bb-e38e66856edc	2023-09-21	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Proficient Rx LP	fbbe54c3-59a1-436c-aba8-188ba7ca70e0	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE
Ezetimibe	EZETIMIBE	Proficient Rx LP	5cbd9bce-e02d-440f-95d5-4eb958d2f4f3	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Ezetimibe generic name: EZETIMIBE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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