Application 078560

Type: ANDA
Sponsor: GLENMARK PHARMS 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
A078560-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2015-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078560-001	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	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`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	A078560-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078560-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078560-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078560-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078560-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078560-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078560-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078560-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078560-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078560-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078560-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078560-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078560-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078560-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078560-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078560-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078560-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078560-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078560-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078560-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078560-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078560-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078560-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078560-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078560-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078560-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078560-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078560-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078560-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078560-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078560-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078560-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078560-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078560-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078560-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078560-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078560-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078560-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078560-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078560-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	Proficient Rx LP	55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560
Ezetimibe	EZETIMIBE	A-S Medication Solutions	5877150f-2807-435e-8e5b-a07dc7dbfd27	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560
Ezetimibe	EZETIMIBE	A-S Medication Solutions	1afdb764-c5da-4982-beae-9be61bdcbcdc	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560
Ezetimibe	EZETIMIBE	Glenmark Pharmaceuticals Inc., USA	ac539a72-77e4-419c-b1d9-42002e9cecf7	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560 ndc (product): 68462-226

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-228	Ezetimibe	Ezetimibe	Par Pharmaceutical Inc	ANDA	Current
49884-228	Ezetimibe	Ezetimibe	Par Pharmaceutical Inc	ANDA	Current
50090-2717	Ezetimibe	Ezetimibe	A-S Medication Solutions	ANDA	Current
60687-284	Ezetimibe	Ezetimibe	American Health Packaging	ANDA	Current
68462-226	Ezetimibe	Ezetimibe	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-226	Ezetimibe	Ezetimibe	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31372	ORIG	2015-06-29