Application 208774

Type: ANDA
Sponsor: APPCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METAXALONE	METAXALONE	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208774-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL			2018-09-24

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208774-001	METAXALONE	800MG	TABLET / ORAL	AB	2018-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208774-001	METAXALONE	800MG	TABLET / ORAL	BX	2018-09-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208774-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208774-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208774-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208774-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208774-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208774-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208774-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208774-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208774-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208774-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208774-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208774-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208774-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208774-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208774-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208774-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208774-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208774-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208774-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208774-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208774-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208774-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208774-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208774-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208774-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208774-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208774-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208774-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208774-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208774-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208774-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208774-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208774-001	BX	1	`cb3db0bc1861…`

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2398	Metaxalone	Metaxalone	Bryant Ranch Prepack	ANDA	Current
63629-2398	Metaxalone	Metaxalone	Bryant Ranch Prepack	ANDA	Current
64980-472	Metaxalone	Metaxalone	Rising Pharmaceuticals, Inc.	ANDA	Current
67296-1778	Metaxalone	Metaxalone	RedPharm Drug, Inc.	ANDA	Current
67296-1778	Metaxalone	Metaxalone	RedPharm Drug, Inc.	ANDA	Current
68788-7499	Metaxalone	Metaxalone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7499	Metaxalone	Metaxalone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7499	Metaxalone	Metaxalone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2275	Metaxalone	Metaxalone	REMEDYREPACK INC.	ANDA	Current
70518-2275	Metaxalone	Metaxalone	REMEDYREPACK INC.	ANDA	Current
70518-2275	Metaxalone	Metaxalone	REMEDYREPACK INC.	ANDA	Current
70518-2275	Metaxalone	Metaxalone	REMEDYREPACK INC.	ANDA	Current
70934-429	Metaxalone	Metaxalone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-429	Metaxalone	Metaxalone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-429	Metaxalone	Metaxalone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-470	Metaxalone	Metaxalone	Proficient Rx LP	ANDA	Current
71205-961	Metaxalone	Metaxalone	Proficient Rx LP	ANDA	Current
71205-961	Metaxalone	Metaxalone	Proficient Rx LP	ANDA	Current
71335-1320	Metaxalone	Metaxalone	Bryant Ranch Prepack	ANDA	Current
72789-122	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-122	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-122	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
80175-0472	Metaxalone	Metaxalone	Central Packaging	ANDA	Current
80175-0472	Metaxalone	Metaxalone	Central Packaging	ANDA	Current
80175-0472	Metaxalone	Metaxalone	Central Packaging	ANDA	Current