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 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
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 2 of 3 · 88 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
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…`
2022-03-09 01:35 UTC	2022-03	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2006-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040667-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2006-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040667-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2006-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040667-001	PRIMIDONE	50MG	TABLET / ORAL		2006-07-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040667-002	PRIMIDONE	250MG	TABLET / ORAL		2006-07-27	`3a93d1ddd44b…`

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 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mysoline	PRIMIDONE	Bausch Health US, LLC	af593171-dabb-4ea3-b44c-89ed457b2c46	2026-09-10	Warnings, Adverse reactions	Name fallback generic name: PRIMIDONE
Primidone	PRIMIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	14f9aee1-4d3e-45e0-ad5c-70bd98667adc	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Bryant Ranch Prepack	93b4b34c-6dba-4aec-b98e-b2b18feb86a9	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	AvKARE	e7a50a67-9653-463e-8c85-315b53f460c8	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Amneal Pharmaceuticals of New York LLC	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Actavis Pharma, Inc.	ae0fa704-818e-4423-8e3a-6cc3390cdd7d	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Advagen Pharma Limited	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Proficient Rx LP	db761e34-8573-4f96-872c-e851b3004e5e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Chartwell RX, LLC	4a8e309f-d89e-4b1a-abb2-856a66ebbff9	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	AvPAK	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	PD-Rx Pharmaceuticals, Inc.	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	PD-Rx Pharmaceuticals, Inc.	0193c0a4-f593-609c-e063-6294a90aaa68	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	NorthStar Rx LLC	182a424b-d142-48c9-996b-059c0885f528	2025-05-21	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
PRIMIDONE	PRIMIDONE	DIRECT RX	c20f803c-e965-9dd8-e053-2995a90a92ba	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: PRIMIDONE generic name: PRIMIDONE
Primidone	PRIMIDONE	Golden State Medical Supply, Inc	e4e493bd-94d7-7e5a-e053-2995a90a2706	2024-12-23	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Amneal Pharmaceuticals LLC	02ba0182-0870-4c0d-a814-a1dc427d47b8	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	American Health Packaging	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Carnegie Pharmaceuticals LLC	dc018b1d-72d3-45a2-84ff-cf9499c7ae97	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Bryant Ranch Prepack	5067ff85-07f5-424c-b072-6907891e7b4e	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Primidone generic name: PRIMIDONE
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	ad8b50e2-e797-4326-a57e-d254da85b6b9	2024-01-09	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