Application 204309

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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
A204309-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB		2015-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204309-001	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	A204309-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`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	A204309-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204309-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204309-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204309-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204309-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204309-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204309-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204309-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204309-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204309-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204309-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204309-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204309-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204309-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204309-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204309-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204309-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204309-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204309-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204309-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204309-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204309-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204309-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204309-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204309-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204309-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204309-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204309-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204309-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204309-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204309-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204309-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204309-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204309-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204309-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204309-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204309-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204309-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204309-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204309-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extended Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	363cd347-d25e-42b9-9ce7-30642f3cb353	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309 ndc (product): 70518-2227
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Bryant Ranch Prepack	a9a1059e-63a2-486e-aa50-eda388f79525	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	American Health Packaging	5b64cb11-673a-41ec-9b2a-1e194ae5eb0c	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	a7bfb3aa-5226-4a48-8156-a9ecc4536fdf	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Aurobindo Pharma Limited	5362ea50-38a4-48b4-a85b-d634c3d8b91a	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309 ndc (product): 65862-692

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3142	Extended Phenytoin Sodium	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
50090-3165	Extended Phenytoin Sodium	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
50090-3165	Extended Phenytoin Sodium	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
50090-3165	Extended Phenytoin Sodium	Phenytoin Sodium	A-S Medication Solutions	ANDA	Current
65862-692	Extended Phenytoin Sodium	Phenytoin Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-692	Extended Phenytoin Sodium	Phenytoin Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-692	Extended Phenytoin Sodium	Phenytoin Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-692	Extended Phenytoin Sodium	Phenytoin Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-692	Extended Phenytoin Sodium	Phenytoin Sodium	Aurobindo Pharma Limited	ANDA	Current
68788-6968	Extended Phenytoin Sodium	Phenytoin Sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2227	Extended Phenytoin Sodium	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2227	Extended Phenytoin Sodium	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2227	Extended Phenytoin Sodium	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2227	Extended Phenytoin Sodium	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2227	Extended Phenytoin Sodium	Phenytoin Sodium	REMEDYREPACK INC.	ANDA	Current
71335-1349	Extended Phenytoin Sodium	Phenytoin Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1349	Extended Phenytoin Sodium	Phenytoin Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1349	Extended Phenytoin Sodium	Phenytoin Sodium	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10322	ORIG	2015-06-12