Application 200892

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETHOSUXIMIDE	ETHOSUXIMIDE	CAPSULE;ORAL	250MG	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
A200892-001	ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE / ORAL			2012-09-25

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	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB	2012-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200892-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	BX	2012-09-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200892-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200892-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200892-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200892-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200892-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200892-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200892-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200892-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200892-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200892-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200892-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200892-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200892-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200892-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200892-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200892-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200892-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200892-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200892-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200892-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200892-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200892-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200892-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200892-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200892-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200892-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200892-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200892-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200892-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200892-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200892-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200892-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200892-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200892-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200892-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200892-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200892-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200892-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200892-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200892-001	BX	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETHOSUXIMIDE	ETHOSUXIMIDE	Chartwell RX, LLC	43fdfd16-c723-452a-9c1d-accf6f7c622e	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200892 application number: ANDA200892

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-532	ETHOSUXIMIDE	ETHOSUXIMIDE	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-532	ETHOSUXIMIDE	ETHOSUXIMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-532	ETHOSUXIMIDE	ETHOSUXIMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
68382-443	ethosuximide	ethosuximide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current