Application 200565

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYTOIN	PHENYTOIN	TABLET, CHEWABLE;ORAL	50MG	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
A200565-001	PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB		2014-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200565-001	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	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200565-001	PHENYTOIN	50MG	TABLET, CHEWABLE / ORAL	AB	2014-04-17	`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	A200565-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200565-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200565-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200565-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200565-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200565-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200565-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200565-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200565-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200565-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200565-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200565-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200565-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200565-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200565-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200565-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200565-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200565-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200565-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200565-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200565-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200565-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200565-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200565-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200565-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200565-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200565-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200565-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200565-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200565-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200565-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200565-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200565-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200565-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200565-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200565-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200565-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200565-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200565-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200565-001	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
Phenytoin	PHENYTOIN	REMEDYREPACK INC.	31e8a777-75b1-4f48-9682-0bcc3189ad26	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200565 application number: ANDA200565 ndc (product): 70518-0841
Phenytoin	PHENYTOIN	Major Pharmaceuticals	08a9d26b-4419-43ec-98f3-43d4534c2e76	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200565 application number: ANDA200565 ndc (product): 0904-7199
Phenytoin	PHENYTOIN	Sun Pharmaceutical Industries, Inc.	78b38e7b-1460-4adc-b738-320ffa6259c2	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200565 application number: ANDA200565 ndc (product): 51672-4146
Phenytoin	PHENYTOIN	NCS HealthCare of KY, LLC dba Vangard Labs	98bd1d9f-b1a4-49eb-a0b4-a790265710dd	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200565 application number: ANDA200565
Phenytoin	PHENYTOIN	American Health Packaging	352007dd-0587-4597-8338-c13eda4c5d63	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200565 application number: ANDA200565 ndc (product): 60687-156

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7199	Phenytoin	Phenytoin	Major Pharmaceuticals	ANDA	Current
51672-4146	Phenytoin	Phenytoin	Taro Pharmaceuticals U.S.A., Inc	ANDA	Current
51672-4146	Phenytoin	Phenytoin	Taro Pharmaceuticals U.S.A., Inc	ANDA	Current
51672-4146	Phenytoin	Phenytoin	Taro Pharmaceuticals U.S.A., Inc	ANDA	Current
51672-4146	Phenytoin	Phenytoin	Taro Pharmaceuticals U.S.A., Inc	ANDA	Current
60687-156	Phenytoin	Phenytoin	American Health Packaging	ANDA	Current
60687-156	Phenytoin	Phenytoin	American Health Packaging	ANDA	Current
60687-156	Phenytoin	Phenytoin	American Health Packaging	ANDA	Current
60687-156	Phenytoin	Phenytoin	American Health Packaging	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current
70518-0841	Phenytoin	Phenytoin	REMEDYREPACK INC.	ANDA	Current