Application 209838

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A209838-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209838-001	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	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`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	A209838-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209838-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209838-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209838-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209838-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209838-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209838-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209838-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209838-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209838-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209838-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209838-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209838-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209838-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209838-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209838-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209838-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209838-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209838-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209838-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209838-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209838-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209838-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209838-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209838-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209838-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209838-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209838-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209838-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209838-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209838-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209838-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209838-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209838-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209838-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209838-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209838-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209838-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209838-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209838-001	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 · 8 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	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	a1cc2018-72a3-48bc-90de-c460f224cf5a	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	3a80b668-51cd-42be-8497-8712b0508422	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838 ndc (product): 71335-2123
Ezetimibe	EZETIMIBE	Aurobindo Pharma Limited	726b1e63-437a-4b3b-b773-3ac47a5c0f38	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838 ndc (product): 59651-052
Ezetimibe	EZETIMIBE	NorthStar Rx LLC	5f5644a9-e019-4e5d-ab6f-3d30b1024c5a	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838 ndc (product): 16714-813
Ezetimibe	EZETIMIBE	A-S Medication Solutions	63ecbbf1-a6de-493f-9710-812ff45cb4d3	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838 ndc (product): 50090-3422
Ezetimibe	EZETIMIBE	A-S Medication Solutions	57d19491-cba1-4720-b69d-481574459201	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Proficient Rx LP	8b128e52-5d0d-4536-aa1f-be192d0989ad	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838

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
0615-8300	Ezetimibe	Ezetimibe	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
16714-813	Ezetimibe	Ezetimibe	NorthStar Rx LLC	ANDA	Current
50090-3422	Ezetimibe	Ezetimibe	A-S Medication Solutions	ANDA	Current
59651-052	Ezetimibe	Ezetimibe	Aurobindo Pharma Limited	ANDA	Current
59651-052	Ezetimibe	Ezetimibe	Aurobindo Pharma Limited	ANDA	Current
59651-052	Ezetimibe	Ezetimibe	Aurobindo Pharma Limited	ANDA	Current
59651-052	Ezetimibe	Ezetimibe	Aurobindo Pharma Limited	ANDA	Current
71335-2123	Ezetimibe	Ezetimibe	Bryant Ranch Prepack	ANDA	Current