Application 040731

Type: ANDA
Sponsor: SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	CAPSULE;ORAL	200MG EXTENDED	No	No
002	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	CAPSULE;ORAL	300MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040731-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL			2008-06-30
A040731-002	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL			2008-06-30

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 3 · 82 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	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL		2008-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL		2008-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040731-001	EXTENDED PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040731-002	EXTENDED PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE / ORAL	AB	2008-06-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040731-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040731-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040731-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040731-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040731-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040731-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040731-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040731-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040731-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040731-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040731-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040731-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040731-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040731-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040731-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040731-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040731-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040731-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040731-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040731-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040731-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040731-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040731-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040731-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040731-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040731-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040731-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040731-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040731-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040731-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040731-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040731-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040731-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040731-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040731-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040731-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040731-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040731-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040731-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040731-002	AB	1	`ea99ee380514…`

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
phenytoin sodium	PHENYTOIN SODIUM	Sun Pharmaceutical Industries, Inc.	c40f66cc-6f4a-4b29-84ba-d265e4848735	2022-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040731 application number: ANDA040731 ndc (product): 62756-299 ndc (product): 62756-432

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
62756-299	phenytoin sodium	phenytoin sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-299	phenytoin sodium	phenytoin sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-299	phenytoin sodium	phenytoin sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-432	phenytoin sodium	phenytoin sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-432	phenytoin sodium	phenytoin sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-432	phenytoin sodium	phenytoin sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current