Application 040765

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	CAPSULE;ORAL	100MG EXTENDED	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
A040765-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB		2008-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040765-001	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	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`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	A040765-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040765-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040765-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040765-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040765-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040765-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040765-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040765-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040765-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040765-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040765-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040765-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040765-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040765-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040765-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040765-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040765-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040765-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040765-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040765-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040765-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040765-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040765-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040765-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040765-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040765-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040765-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040765-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040765-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040765-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040765-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040765-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040765-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040765-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040765-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040765-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040765-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040765-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040765-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040765-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Amneal Pharmaceuticals LLC	7e467c02-49a0-4b62-b537-430fdfa4f10e	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040765 application number: ANDA040765 ndc (product): 65162-212
PHENYTOIN SODIUM	PHENYTOIN SODIUM	DIRECT RX	df0bf42b-ce9a-42c3-8c24-46f1ea3bd214	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040765 application number: ANDA040765 ndc (product): 61919-815

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6187	Extended Phenytoin Sodium	Phenytoin Sodium	Major Pharmaceuticals	ANDA	Current
0904-6187	Extended Phenytoin Sodium	Phenytoin Sodium	Major Pharmaceuticals	ANDA	Current
10135-603	Extended Phenytoin Sodium	Phenytoin Sodium	Marlex Pharmaceuticals Inc	ANDA	Current
42291-772	Extended Phenytoin Sodium	Phenytoin Sodium	AvKARE	ANDA	Current
42291-772	Extended Phenytoin Sodium	Phenytoin Sodium	AvKARE	ANDA	Current
43063-492	Extended Phenytoin Sodium	Phenytoin Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-492	Extended Phenytoin Sodium	Phenytoin Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-492	Extended Phenytoin Sodium	Phenytoin Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-492	Extended Phenytoin Sodium	Phenytoin Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-492	Extended Phenytoin Sodium	Phenytoin Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2089	Extended Phenytoin Sodium	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
50090-2089	Extended Phenytoin Sodium	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
53808-1040	Extended Phenytoin Sodium	Phenytoin Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-7979	Extended Phenytoin Sodium	Phenytoin Sodium	Cardinal Health 107, LLC	ANDA	Current
55154-7979	Extended Phenytoin Sodium	Phenytoin Sodium	Cardinal Health	ANDA	Current
55154-7979	Extended Phenytoin Sodium	Phenytoin Sodium	Cardinal Health	ANDA	Current
61919-815	PHENYTOIN SODIUM	PHENYTOIN SODIUM	DIRECT RX	ANDA	Current
61919-815	PHENYTOIN SODIUM	PHENYTOIN SODIUM	DIRECT RX	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
65162-212	Extended Phenytoin Sodium	Phenytoin Sodium	Amneal Pharmaceuticals LLC	ANDA	Current
68084-376	Extended Phenytoin Sodium	Phenytoin Sodium	American Health Packaging	ANDA	Current
68084-376	Extended Phenytoin Sodium	Phenytoin Sodium	American Health Packaging	ANDA	Current
68084-376	Extended Phenytoin Sodium	Phenytoin Sodium	American Health Packaging	ANDA	Current
68084-376	Extended Phenytoin Sodium	Phenytoin Sodium	American Health Packaging	ANDA	Current
70518-0231	Extended Phenytoin Sodium	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
71610-479	Extended Phenytoin Sodium	Phenytoin Sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current