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001	SKELAXIN	METAXALONE	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 43.

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N013217-001	SKELAXIN	METAXALONE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N013217-003	SKELAXIN	METAXALONE	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30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 · 86 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
2026-09-14 22:38:34	2026-08	N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

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 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2026-09-14 22:38:34	2026-08	N013217-003	7122566	2026-02-06	U-915	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N013217-003	7122566	2026-02-06	U-915	`caaa826d4ba7…`
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…`

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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	Northwind Health Company, LLC	d9cefc55-7643-ce9b-e053-2a95a90aff12	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Northwind Health Company, LLC	f2b46d69-1c20-5ae9-e053-2a95a90a60a9	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	A-S Medication Solutions	d4caa7c6-afb5-43a2-ba38-cf30106b1d62	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	AvPAK	9b21a974-6a5a-9efb-e9de-470363217126	2025-11-26	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	PHOENIX RX LLC	3a7c8b4d-7add-cb31-e063-6294a90a37f8	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	PHOENIX RX LLC	413b300d-4163-afef-e063-6394a90a618f	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Actavis Pharma, Inc.	b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a0	2025-07-30	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	BluePoint Laboratories	c91c0fb0-0b61-4e45-8bea-d0bf57ca7068	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	36c1d263-48ce-831b-e063-6394a90a0a2b	2025-05-29	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Amneal Pharmaceuticals LLC	3aa9dba9-29b0-4520-a0f7-66d19d52c6bc	2025-03-28	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Major Pharmaceuticals	8c1e10fe-0330-4bf8-a94d-aeed80f6aef1	2025-03-03	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	PD-Rx Pharmaceuticals, Inc.	edc6ba8d-2d45-4833-8dc7-e2d4e5d72856	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Dr. Reddys Laboratories Limited	02eb5938-cd59-4a81-853d-a4148d813a94	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	b3279496-293e-7e1f-e053-2a95a90ab506	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Advanced Rx Pharmacy of Tennessee, LLC	bd1c9022-aadc-af1f-e053-2995a90a0b42	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Advanced Rx Pharmacy of Tennessee, LLC	b713a0f2-d47a-0ae7-e053-2995a90a5b85	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Quality Care Products, LLC	f05bb280-6736-4215-be5b-0e5f7991cd87	2024-12-17	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Bryant Ranch Prepack	a12304b7-6477-4518-8db5-898879c62caf	2024-11-13	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Bryant Ranch Prepack	c2dd7071-cba3-410c-ade5-9d7e5af42038	2024-09-16	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Amneal Pharmaceuticals of New York LLC	de3448df-4ca1-44ec-bad1-486549cddf64	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: METAXALONE

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 · 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