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001	SKELAXIN	METAXALONE	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N013217-001	SKELAXIN	METAXALONE	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N013217-003	SKELAXIN	METAXALONE	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30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N013217-001	SKELAXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`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N013217-003	SKELAXIN	800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2002-08-30	`84e616aacf4f…`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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metaxalone	METAXALONE	American Health Packaging	b6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c	2024-08-29	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	ScieGen Pharmaceuticals, Inc.	1cef46bb-e590-4a58-82e0-7cf1fc3836a5	2024-08-21	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Bryant Ranch Prepack	a662fd07-2896-4cbb-bafc-aa5ab179a148	2024-08-12	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Bryant Ranch Prepack	7f758053-2367-4c5f-9bbd-ce8ce263a615	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Bryant Ranch Prepack	c86862a4-f6ff-4268-bec6-35dedbe4cd4a	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Bryant Ranch Prepack	07ccff59-e335-40be-9e40-fd2d08197617	2024-07-24	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Lannett Company, Inc.	8294bb3c-c8eb-474c-b567-e53cf81249e9	2024-06-27	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Proficient Rx LP	9c7d0cd4-625a-485e-9d13-ce854630148c	2024-03-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Misemer Pharmaceuticals, Inc.	d0276e7b-a1c9-61f3-e053-2a95a90ae3aa	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Proficient Rx LP	c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6	2024-01-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	A-S Medication Solutions	ef47682d-ea41-465e-aa21-cc773d45a6f0	2023-10-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	CIPLA USA INC.	c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4	2023-06-08	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Amneal Pharmaceuticals of New York LLC	f06f2b96-3684-483c-89f7-6c9201fd4664	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Proficient Rx LP	fba1601d-3ac4-41cf-9548-35ec4994a95e	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Asclemed USA, Inc.	02c42f72-5d78-436d-8105-8c0f8d4c0d91	2022-07-25	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Proficient Rx LP	ee86f52c-fbf4-4882-bb7d-50220736fbb3	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Doc Rx	4a558a2f-f9be-40d1-8d02-dd0c8c501ef6	2022-03-24	Warnings, Adverse reactions	Name fallback generic name: METAXALONE
Metaxalone	METAXALONE	Doc Rx	87518046-c959-d5f3-e053-2a95a90a5f7e	2021-09-28	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