Application 214896

Type: ANDA
Sponsor: RUBICON

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
003	PRIMIDONE	PRIMIDONE	TABLET;ORAL	125MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214896-001	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28
A214896-002	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28
A214896-003	PRIMIDONE	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214896-001	AB
A214896-002	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 · 80 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	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A214896-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214896-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214896-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214896-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214896-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214896-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214896-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214896-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214896-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214896-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214896-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214896-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214896-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214896-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214896-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214896-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214896-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214896-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214896-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214896-002	AB	1	`a67488948f0b…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	Advagen Pharma Limited	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214896 application number: ANDA214896 ndc (product): 72888-160 ndc (product): 72888-045 ndc (product): 72888-046
Primidone	PRIMIDONE	NorthStar Rx LLC	182a424b-d142-48c9-996b-059c0885f528	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214896 application number: ANDA214896
Primidone	PRIMIDONE	TruPharma LLC.	c60b3a92-4404-4a89-b2c5-c23ff72bedad	2023-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214896 application number: ANDA214896

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-045	Primidone	Primidone	Advagen Pharma Limited	ANDA	Current
72888-045	Primidone	Primidone	Advagen Pharma Limited	ANDA	Current
72888-046	Primidone	Primidone	Advagen Pharma Limited	ANDA	Current
72888-046	Primidone	Primidone	Advagen Pharma Limited	ANDA	Current
72888-160	Primidone	Primidone	Advagen Pharma Limited	ANDA	Current