Application 040342

Type: ANDA
Sponsor: VISTAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYTOIN	PHENYTOIN	SUSPENSION;ORAL	125MG/5ML	No	No
002	PHENYTOIN	PHENYTOIN	SUSPENSION;ORAL	125MG/5ML	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
A040342-001	PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL			2001-01-31
A040342-002	PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL			2005-08-18

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 · 70 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	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2005-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`3f01610625f2…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040342-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040342-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040342-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040342-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040342-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040342-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040342-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040342-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040342-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040342-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040342-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040342-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040342-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040342-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040342-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040342-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040342-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040342-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040342-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040342-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040342-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040342-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040342-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040342-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040342-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040342-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040342-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040342-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040342-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040342-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040342-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040342-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040342-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040342-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040342-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040342-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040342-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040342-002	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin Infatabs	PHENYTOIN	Prasco Laboratories	3580e6a8-f7c3-44a0-a1eb-2a84ae589d21	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN
Phenytoin	PHENYTOIN	REMEDYREPACK INC.	31e8a777-75b1-4f48-9682-0bcc3189ad26	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Dilantin Infatabs	PHENYTOIN	Parke-Davis Div of Pfizer Inc	ca119a89-2394-4d34-8078-cd1fa4e8e2f1	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN
Phenytoin	PHENYTOIN	Major Pharmaceuticals	08a9d26b-4419-43ec-98f3-43d4534c2e76	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	Sun Pharmaceutical Industries, Inc.	78b38e7b-1460-4adc-b738-320ffa6259c2	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	NCS HealthCare of KY, LLC dba Vangard Labs	98bd1d9f-b1a4-49eb-a0b4-a790265710dd	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	American Health Packaging	f9fe4c92-2761-4cb4-9cf3-7066e240e014	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	Sun Pharmaceutical Industries, Inc.	093fd736-5971-47af-b4ef-08c1696cebe8	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	ATLANTIC BIOLOGICALS CORP.	09daf485-3355-44cb-92af-072dd281e129	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	Mylan Pharmaceuticals Inc.	37943ec1-a8d2-42df-967e-6f96f84c017b	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	PAI Holdings, LLC dba PAI Pharma	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin	PHENYTOIN	American Health Packaging	352007dd-0587-4597-8338-c13eda4c5d63	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Phenytoin Infatabs	PHENYTOIN	NCS HealthCare of KY, LLC dba Vangard Labs	0d240b2b-bc5c-4989-a20b-54ed37a09a4f	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN
Phenytoin	PHENYTOIN	Rising Pharma Holdings, Inc.	e95cad66-b5f9-4802-a35f-fed340bf09ab	2024-03-14	Warnings, Adverse reactions	Name fallback brand name: Phenytoin generic name: PHENYTOIN
Dilantin-125	PHENYTOIN	Viatris Specialty LLC	f339f9e4-b289-4efe-82b9-46c57d1dc277	2023-02-02	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66689-036	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current
66689-036	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current
66689-036	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current
66689-036	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current
66689-036	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current
66689-036	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current
66689-775	Phenytoin	Phenytoin	VistaPharm, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29934	ORIG	2001-01-31