Application 080857

Type: ANDA
Sponsor: LANNETT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENYLAN SODIUM	PHENYTOIN SODIUM	CAPSULE;ORAL	30MG PROMPT	No	No
002	DIPHENYLAN SODIUM	PHENYTOIN SODIUM	CAPSULE;ORAL	100MG PROMPT	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A080857-001	DIPHENYLAN SODIUM	PHENYTOIN SODIUM	30MG PROMPT	CAPSULE / ORAL		Approved before 1982
A080857-002	DIPHENYLAN SODIUM	PHENYTOIN SODIUM	100MG PROMPT	CAPSULE / ORAL		Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080857-001	DIPHENYLAN SODIUM	30MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080857-002	DIPHENYLAN SODIUM	100MG PROMPT	CAPSULE / ORAL	Approved before 1982	`3a93d1ddd44b…`

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin Sodium	PHENYTOIN SODIUM	Major Pharmaceuticals	46d5c0d1-a97b-46d9-8cf4-994780673337	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	A-S Medication Solutions	ef4e97a7-cd18-47a9-a016-2eca5481a87e	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Extended Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	363cd347-d25e-42b9-9ce7-30642f3cb353	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Amneal Pharmaceuticals LLC	7e467c02-49a0-4b62-b537-430fdfa4f10e	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	e33ce05d-9c60-4ede-8b13-e8c41a3de25d	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Coupler LLC	51b660c3-7d88-77b2-e063-6294a90a0286	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Golden State Medical Supply, Inc.	36262a4c-33f1-40a5-e063-6394a90ad36a	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	844a16db-17d5-44da-819d-54f3e19cfec2	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Sun Pharmaceutical Industries, Inc.	601f7353-225d-4a5d-9810-3869c2c21874	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	AvPAK	4c2542b8-ac54-e85d-e063-6294a90a759b	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUM	PHENYTOIN SODIUM	DIRECT RX	df0bf42b-ce9a-42c3-8c24-46f1ea3bd214	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Proficient Rx LP	f4353734-29b0-4027-824d-2fc97f778c67	2026-02-01	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	ProPharma Distribution	43060ca9-58a7-3371-e063-6294a90a5799	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Henry Schein, Inc.	889dd22c-46f0-48d0-b18e-a3783c5fa653	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	3bc82d23-3950-f181-e063-6394a90ad565	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Bryant Ranch Prepack	a9a1059e-63a2-486e-aa50-eda388f79525	2025-06-11	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Extended Phenytoin Sodium	PHENYTOIN SODIUM	American Health Packaging	5b64cb11-673a-41ec-9b2a-1e194ae5eb0c	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
PHENYTOIN SODIUM	PHENYTOIN SODIUM	Henry Schein, Inc.	a52cf1bd-dc1f-47be-aba8-29066d9a50fb	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Phenytoin Sodium	PHENYTOIN SODIUM	Aphena Pharma Solutions - Tennessee, LLC	29b8d0a2-a96e-46a5-e063-6394a90a7113	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM
Extended Phenytoin Sodium	PHENYTOIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	a7bfb3aa-5226-4a48-8156-a9ecc4536fdf	2024-10-18	Warnings, Adverse reactions	Name fallback generic name: PHENYTOIN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.