Application 022503

Type: NDA
Sponsor: PRIMUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METAXALONE	METAXALONE	TABLET;ORAL	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022503-001	METAXALONE	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, RS	2015-06-01

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022503-001	11918559	2039-07-29		Drug product	2024-03-13
N022503-001	12485111	2043-05-14	U-4453	Drug product	2026-04-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022503-001	METAXALONE	640MG	TABLET / ORAL	RLD	2015-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022503-001	METAXALONE	640MG	TABLET / ORAL	RLD	2015-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2015-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, RS	2015-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022503-001	METAXALONE	640MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2015-06-01	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022503-001	11918559	2039-07-29		Drug product	2024-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022503-001	12485111	2043-05-14	U-4453	Drug product	2026-04-10	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	INA Pharmaceutics Inc	fc6de1a6-26aa-47ac-a5d2-bf127a6ca563	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022503 application number: NDA022503

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82196	SUPPL	2025-05-15
82256	SUPPL	2025-05-08
77229	SUPPL	2024-01-17
77207	SUPPL	2024-01-11
70320	SUPPL	2022-03-01
70286	SUPPL	2022-02-28
42541	ORIG	2015-12-09
24326	ORIG	2015-12-09
29788	ORIG	2015-06-09
17650	ORIG	2015-06-04