Application 084903

Type: ANDA
Sponsor: LANNETT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRIMIDONE	PRIMIDONE	TABLET;ORAL	250MG	No	No
002	PRIMIDONE	PRIMIDONE	TABLET;ORAL	50MG	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
A084903-001	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982
A084903-002	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084903-001	AB
A084903-002	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 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	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A084903-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A084903-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A084903-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084903-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084903-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084903-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084903-002	AB	1	`4b0b4de00fa7…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	Chartwell RX, LLC	4a8e309f-d89e-4b1a-abb2-856a66ebbff9	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903
Primidone	PRIMIDONE	Golden State Medical Supply, Inc	e4e493bd-94d7-7e5a-e053-2995a90a2706	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903 ndc (product): 51407-637 ndc (product): 51407-638
Primidone	PRIMIDONE	American Health Packaging	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903 ndc (product): 68084-202 ndc (product): 68084-203
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	ad8b50e2-e797-4326-a57e-d254da85b6b9	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903
Primidone	PRIMIDONE	Lannett Company, Inc.	a1a817f7-c190-4825-94eb-442f477187e3	2020-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903 ndc (product): 0527-1231 ndc (product): 0527-1301

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1231	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1231	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1231	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1231	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1231	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1301	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1301	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1301	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1301	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0527-1301	Primidone	Primidone	Lannett Company, Inc.	ANDA	Current
0615-5591	Primidone	Primidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7738	Primidone	Primidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5559	Primidone	Primidone	Major Pharmaceuticals	ANDA	Current
0904-5559	Primidone	Primidone	Major Pharmaceuticals	ANDA	Current
0904-5559	Primidone	Primidone	Major Pharmaceuticals	ANDA	Current
10135-522	Primidone	Primidone	Marlex Pharmaceuticals Inc	ANDA	Current
10135-522	Primidone	Primidone	Marlex Pharmaceuticals Inc	ANDA	Current
10135-522	Primidone	Primidone	Marlex Pharmaceuticals Inc	ANDA	Current
10135-540	Primidone	Primidone	Marlex Pharmaceuticals Inc	ANDA	Current
10135-540	Primidone	Primidone	Marlex Pharmaceuticals Inc	ANDA	Current
10135-540	Primidone	Primidone	Marlex Pharmaceuticals Inc	ANDA	Current
51407-637	Primidone	Primidone	Golden State Medical Supply, Inc.	ANDA	Current
51407-638	Primidone	Primidone	Golden State Medical Supply, Inc.	ANDA	Current
68084-202	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-202	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-202	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-202	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-202	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-202	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-203	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-203	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-203	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-203	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-203	Primidone	Primidone	American Health Packaging	ANDA	Current
68084-203	Primidone	Primidone	American Health Packaging	ANDA	Current
71335-1158	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
71335-1158	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
71335-1158	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
71610-191	Primidone	Primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current