Application 209234

Type: ANDA
Sponsor: ALKEM LABS 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 42.

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
A209234-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209234-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209234-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209234-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209234-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209234-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209234-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209234-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209234-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209234-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209234-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209234-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209234-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209234-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209234-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209234-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209234-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209234-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209234-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209234-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209234-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209234-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209234-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209234-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209234-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209234-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209234-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209234-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209234-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209234-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209234-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209234-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209234-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209234-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209234-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209234-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209234-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209234-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209234-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209234-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209234-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209234-001	AB	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	Major Pharmaceuticals	e257ed7f-5015-4f1d-93f4-5adf5797643d	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 0904-7103
Ezetimibe	EZETIMIBE	American Health Packaging	0e9a9eda-1b2a-4475-8483-0f410a17c524	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 60687-373
Ezetimibe	EZETIMIBE	A-S Medication Solutions	dd8a09cb-f014-4650-9da2-4ad1581c9741	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	c92292f5-5444-4247-927e-db7bf6816109	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 71335-1127
Ezetimibe	EZETIMIBE	Ascend Laboratories, LLC	206d702c-b09a-4555-972b-6555d6d6d6e6	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 67877-490
Ezetimibe	EZETIMIBE	A-S Medication Solutions	9a04678f-e961-45aa-b3bb-e38e66856edc	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 50090-3657
Ezetimibe	EZETIMIBE	Proficient Rx LP	fbbe54c3-59a1-436c-aba8-188ba7ca70e0	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 71205-277

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7103	Ezetimibe	Ezetimibe	Major Pharmaceuticals	ANDA	Current
0904-7103	Ezetimibe	Ezetimibe	Major Pharmaceuticals	ANDA	Current
50090-3657	Ezetimibe	Ezetimibe	A-S Medication Solutions	ANDA	Current
50090-3657	Ezetimibe	Ezetimibe	A-S Medication Solutions	ANDA	Current
60687-373	Ezetimibe	Ezetimibe	American Health Packaging	ANDA	Current
60687-373	Ezetimibe	Ezetimibe	American Health Packaging	ANDA	Current
60687-373	Ezetimibe	Ezetimibe	American Health Packaging	ANDA	Current
67877-490	Ezetimibe	Ezetimibe	Ascend Laboratories, LLC	ANDA	Current
67877-490	Ezetimibe	Ezetimibe	Ascend Laboratories, LLC	ANDA	Current
68788-8297	Ezetimibe	Ezetimibe	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1783	Ezetimibe	Ezetimibe	REMEDYREPACK INC.	ANDA	Current
70518-1927	Ezetimibe	Ezetimibe	REMEDYREPACK INC.	ANDA	Current
70518-2262	Ezetimibe	Ezetimibe	REMEDYREPACK INC.	ANDA	Current
70518-2262	Ezetimibe	Ezetimibe	REMEDYREPACK INC.	ANDA	Current
70518-2262	Ezetimibe	Ezetimibe	REMEDYREPACK INC.	ANDA	Current
71205-277	Ezetimibe	Ezetimibe	Proficient Rx LP	ANDA	Current
71205-277	Ezetimibe	Ezetimibe	Proficient Rx LP	ANDA	Current
71205-277	Ezetimibe	Ezetimibe	Proficient Rx LP	ANDA	Current
71335-1127	Ezetimibe	Ezetimibe	Bryant Ranch Prepack	ANDA	Current
72189-118	EZETIMIBE	EZETIMIBE	direct rx	ANDA	Current
72189-118	EZETIMIBE	EZETIMIBE	direct rx	ANDA	Current