Application 040667

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRIMIDONE	PRIMIDONE	TABLET;ORAL	50MG	No	No
002	PRIMIDONE	PRIMIDONE	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040667-001	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL			2006-07-27
A040667-002	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL			2006-07-27

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 · 86 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
2026-09-14 22:38:34	2026-08	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2006-07-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040667-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040667-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040667-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040667-002	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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	TruPharma LLC.	c60b3a92-4404-4a89-b2c5-c23ff72bedad	2023-03-08	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	1c56d09c-4224-4875-bb22-e8bfd595d378	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Oxford Pharmaceuticals, LLC	439096a4-c5d5-4ad8-be9c-238973a3e290	2022-04-05	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	91de277e-34b8-4ee1-8846-f02aea626089	2021-10-15	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	70b93341-ce93-4be5-a782-87c1a26129d7	2021-08-19	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Lannett Company, Inc.	a1a817f7-c190-4825-94eb-442f477187e3	2020-06-11	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Dr. Reddy's Laboratories Limited	a4f917f4-2aa2-c3ed-071e-232fa0f125e8	2010-12-02	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1482	Primidone	Primidone	West-ward Pharmaceutical Corp	ANDA	Current
0143-1484	Primidone	Primidone	West-ward Pharmaceutical Corp	ANDA	Current
0615-2521	Primidone	primidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current