Application 013217

Type: NDA
Sponsor: KING PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SKELAXIN	METAXALONE	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	SKELAXIN	METAXALONE	TABLET;ORAL	800MG	Yes	Yes

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

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
N013217-001	SKELAXIN	METAXALONE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N013217-003	SKELAXIN	METAXALONE	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N013217-003	7122566	2026-02-06	U-915

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 · 82 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
2026-02-19 14:30 UTC	2026-02	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013217-003	SKELAXIN	800MG	TABLET / ORAL		RLD	2002-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013217-001	SKELAXIN	400MG	TABLET / ORAL		RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013217-001	SKELAXIN	400MG	TABLET / ORAL		RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013217-003	SKELAXIN	800MG	TABLET / ORAL	AB	RLD, RS	2002-08-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013217-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013217-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013217-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013217-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013217-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013217-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013217-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013217-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013217-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013217-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013217-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013217-003	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013217-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013217-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013217-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013217-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013217-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013217-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N013217-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013217-003	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013217-003	7122566	2026-02-06	U-915	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013217-003	7122566	2026-02-06	U-915	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013217-003	7122566	2026-02-06	U-915	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013217-003	7122566	2026-02-06	U-915	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013217-003	7122566	2026-02-06	U-915	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013217-003	7122566	2026-02-06	U-915	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013217-003	7122566	2026-02-06	U-915	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013217-003	7122566	2026-02-06	U-915	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013217-003	7122566	2026-02-06	U-915	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013217-003	7122566	2026-02-06	U-915	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013217-003	7122566	2026-02-06	U-915	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013217-003	7122566	2026-02-06	U-915	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013217-003	7122566	2026-02-06	U-915	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013217-003	7122566	2026-02-06	U-915	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013217-003	7122566	2026-02-06	U-915	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013217-003	7122566	2026-02-06	U-915	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013217-003	7122566	2026-02-06	U-915	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013217-003	7714006	2021-12-03	U-1050	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013217-003	7122566	2026-02-06	U-915	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013217-003	7122566	2026-02-06	U-915	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013217-003	7714006	2021-12-03	U-1050	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013217-003	7122566	2026-02-06	U-915	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013217-003	7714006	2021-12-03	U-1050	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013217-003	7122566	2026-02-06	U-915	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013217-003	7714006	2021-12-03	U-1050	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N013217-003	7122566	2026-02-06	U-915	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013217-003	7714006	2021-12-03	U-1050	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N013217-003	7122566	2026-02-06	U-915	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013217-003	7714006	2021-12-03	U-1050	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N013217-003	7122566	2026-02-06	U-915	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013217-003	7714006	2021-12-03	U-1050	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N013217-003	7122566	2026-02-06	U-915	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013217-003	7714006	2021-12-03	U-1050	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N013217-003	7122566	2026-02-06	U-915	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013217-003	7714006	2021-12-03	U-1050	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N013217-003	7122566	2026-02-06	U-915	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013217-003	7122566	2026-02-06	U-915	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013217-003	7122566	2026-02-06	U-915	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013217-003	7122566	2026-02-06	U-915	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013217-003	7122566	2026-02-06	U-915	`a72a2bbeb626…`

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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	Preferred Pharmaceuticals Inc.	01199953-8124-4ace-947f-7b11989b44c3	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	REMEDYREPACK INC.	e9e45029-b1a4-435f-b9ca-cdfa01051bc8	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Preferred Pharmaceuticals, Inc.	1541da6a-7681-40bc-b67e-28e02a950d72	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Preferred Pharmaceuticals Inc.	8aa84e64-0075-4f22-a576-da085f32d56c	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	St. Mary's Medical Park Pharmacy	5de36266-3964-5aca-e053-2991aa0a2205	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Direct_Rx	8c3bc0a2-5c93-e1d6-e053-2995a90a0b83	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
METAXALONE	METAXALONE	DIRECT RX	9b7b4fc3-3f38-db66-e053-2995a90aaadb	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Direct_Rx	91432cd0-8404-8029-e053-2a95a90adc1b	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	St. Mary's Medical Park Pharmacy	a23ca660-b066-1396-e053-2a95a90a30b2	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Highmark Pharma LLC	834be129-cfb5-4420-b660-025833376b3e	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Asclemed USA, Inc.	f4a0e910-2b20-46d4-b49e-21fb15925b58	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	4facde6f-1828-9138-e063-6294a90a1ec1	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Sportpharm LLC	3e7efad7-2752-4f7d-ba30-40f17d13e4c3	2026-04-05	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	AvKARE	4c3b2aa4-fe65-507c-e063-6394a90a7b00	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	AvKARE	4c3ae824-48a9-fd91-e063-6394a90a9a54	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Sportpharm LLC	5bcdc9d3-8827-4d05-8783-4519f1b284a3	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	INA Pharmaceutics Inc	fc6de1a6-26aa-47ac-a5d2-bf127a6ca563	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	REMEDYREPACK INC.	fe82b33b-2a24-4477-91ca-b23e59156675	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Direct_Rx	45726fbc-3450-63f7-e063-6394a90a671a	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
METAXALONE	METAXALONE	DIRECT RX	49250bbf-fbfe-07cd-e054-00144ff88e88	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: METAXALONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1748	Metaxalone	Metaxalone	Impax Generics	NDA	Current
0115-1748	Metaxalone	Metaxalone	Amneal Pharmaceuticals of New York LLC	NDA	Current
0115-1748	Metaxalone	Metaxalone	Amneal Pharmaceuticals of New York LLC	NDA	Current
10544-002	Metaxalone	Metaxalone	Blenheim Pharmacal, Inc.	NDA	Current
10544-524	SKELAXIN	metaxalone	Blenheim Pharmacal, Inc.	NDA	Current
21695-123	Skelaxin	Metaxalone	Rebel Distributors Corp	NDA	Current
35356-570	Metaxalone	Metaxalone	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
42254-040	Metaxalone	Metaxalone	Rebel Distributors Corp	NDA	Current
43063-239	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-239	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-239	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-239	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-581	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
50436-3024	Metaxalone	Metaxalone	Unit Dose Services	NDA	Current
51655-163	Metaxalone	Metaxalone	Northwind Pharmaceuticals	NDA	Current
52959-596	Metaxalone	Metaxalone	H.J. Harkins Company, Inc.	NDA	Current
55289-736	SKELAXIN	metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-736	SKELAXIN	metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-736	SKELAXIN	metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-736	SKELAXIN	metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-736	SKELAXIN	metaxalone	PD-Rx Pharmaceuticals, Inc.	NDA	Current
60793-136	SKELAXIN	metaxalone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-136	SKELAXIN	metaxalone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61919-346	METAXALONE	METAXALONE	DIRECT RX	NDA	Current
61919-346	METAXALONE	METAXALONE	DIRECT RX	NDA	Current
63629-2768	Metaxalone	Metaxalone	Bryant Ranch Prepack	NDA	Current
64720-321	Metaxalone	Metaxalone	CorePharma, LLC	NDA	Current
64720-321	Metaxalone	Metaxalone	CorePharma, LLC	NDA	Current
68151-4668	Metaxalone	Metaxalone	Carilion Materials Management	NDA	Current
68258-7100	Metaxalone	Metaxalone	Dispensing Solutions, Inc.	NDA	Current
68788-0881	Skelaxin	Metaxalone	Preferred Pharmaceuticals, Inc	NDA	Current
68788-9896	Metaxalone	Metaxalone	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-1161	Metaxalone	Metaxalone	REMEDYREPACK INC.	NDA	Current
70518-1161	Metaxalone	Metaxalone	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78879	SUPPL	2024-06-24
78871	SUPPL	2024-06-24
52908	SUPPL	2018-03-12
52874	SUPPL	2018-03-08
33103	SUPPL	2012-11-27
40686	SUPPL	2009-09-14
40685	SUPPL	2009-09-14
40684	SUPPL	2009-09-14
20043	SUPPL	2009-09-14
20041	SUPPL	2009-09-14
12045	SUPPL	2008-11-03
33102	SUPPL	2006-12-04
12044	SUPPL	2006-12-04
20042	SUPPL	2006-05-10
10831	SUPPL	2002-08-30
355	SUPPL	2002-08-30
356	SUPPL	2002-06-20