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