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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A208774-001	METAXALONE	800MG	TABLET / ORAL		2018-09-24	`84e616aacf4f…`
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…`

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