Application 203931

Type: ANDA
Sponsor: SANDOZ INC

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
A203931-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203931-001	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	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203931-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`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	A203931-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203931-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203931-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203931-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203931-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203931-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203931-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203931-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203931-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203931-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203931-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203931-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203931-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203931-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203931-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203931-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203931-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203931-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203931-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203931-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203931-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203931-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203931-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203931-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203931-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203931-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203931-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203931-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203931-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203931-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203931-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203931-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203931-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203931-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203931-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203931-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203931-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203931-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203931-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203931-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	03609879-bad2-4e75-83fe-1e1a2fd300c3	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203931 application number: ANDA203931 ndc (product): 63629-7413
Ezetimibe	EZETIMIBE	Sandoz Inc	ebcb6655-fd60-4099-8099-be911c5b32ae	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203931 application number: ANDA203931 ndc (product): 0781-5690
Ezetimibe	EZETIMIBE	Proficient Rx LP	5cbd9bce-e02d-440f-95d5-4eb958d2f4f3	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203931 application number: ANDA203931 ndc (product): 71205-145

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
0781-5690	Ezetimibe	Ezetimibe	Sandoz Inc	ANDA	Current
0781-5690	Ezetimibe	Ezetimibe	Sandoz Inc	ANDA	Current
63629-7413	Ezetimibe	Ezetimibe	Bryant Ranch Prepack	ANDA	Current
70518-3334	Ezetimibe	Ezetimibe	REMEDYREPACK INC.	ANDA	Current
71205-145	Ezetimibe	Ezetimibe	Proficient Rx LP	ANDA	Current
71205-145	Ezetimibe	Ezetimibe	Proficient Rx LP	ANDA	Current