Application 207466

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METAXALONE	METAXALONE	TABLET;ORAL	800MG	No	No
002	METAXALONE	METAXALONE	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207466-001	METAXALONE	METAXALONE	800MG	TABLET / ORAL	AB		2017-08-31
A207466-002	METAXALONE	METAXALONE	400MG	TABLET / ORAL	AB		2020-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207466-001	AB
A207466-002	AB

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 · 78 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
2026-02-19 14:30 UTC	2026-02	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207466-002	METAXALONE	400MG	TABLET / ORAL	AB	2020-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207466-001	METAXALONE	800MG	TABLET / ORAL	AB	2017-08-31	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207466-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207466-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207466-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207466-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207466-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207466-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207466-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207466-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207466-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207466-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207466-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207466-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207466-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207466-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207466-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207466-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207466-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207466-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207466-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207466-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207466-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207466-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207466-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207466-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207466-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207466-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207466-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207466-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207466-001	AB	1	`87673890dc5c…`

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 1 · 16 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	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Preferred Pharmaceuticals Inc.	8aa84e64-0075-4f22-a576-da085f32d56c	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Highmark Pharma LLC	834be129-cfb5-4420-b660-025833376b3e	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	4facde6f-1828-9138-e063-6294a90a1ec1	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	REMEDYREPACK INC.	fe82b33b-2a24-4477-91ca-b23e59156675	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Northwind Health Company, LLC	f2b46d69-1c20-5ae9-e053-2a95a90a60a9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	BluePoint Laboratories	c91c0fb0-0b61-4e45-8bea-d0bf57ca7068	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 68001-485
Metaxalone	METAXALONE	Advanced Rx of Tennessee, LLC	36c1d263-48ce-831b-e063-6394a90a0a2b	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466
Metaxalone	METAXALONE	Major Pharmaceuticals	8c1e10fe-0330-4bf8-a94d-aeed80f6aef1	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 0904-6831
Metaxalone	METAXALONE	PD-Rx Pharmaceuticals, Inc.	edc6ba8d-2d45-4833-8dc7-e2d4e5d72856	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 72789-028
Metaxalone	METAXALONE	Dr. Reddys Laboratories Limited	02eb5938-cd59-4a81-853d-a4148d813a94	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 55111-650
Metaxalone	METAXALONE	American Health Packaging	b6afb4d3-eb3e-4e9f-9aa9-a44cfacb959c	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 60687-663
Metaxalone	METAXALONE	ScieGen Pharmaceuticals, Inc.	1cef46bb-e590-4a58-82e0-7cf1fc3836a5	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 50228-474 ndc (product): 50228-323
Metaxalone	METAXALONE	Proficient Rx LP	9c7d0cd4-625a-485e-9d13-ce854630148c	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 71205-016
Metaxalone	METAXALONE	Misemer Pharmaceuticals, Inc.	d0276e7b-a1c9-61f3-e053-2a95a90ae3aa	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466 ndc (product): 0276-0508
Metaxalone	METAXALONE	CIPLA USA INC.	c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207466 application number: ANDA207466

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0276-0508	Metaxalone	Metaxalone	Misemer Pharmaceuticals, Inc.	ANDA	Current
0904-6831	Metaxalone	Metaxalone	Major Pharmaceuticals	ANDA	Current
0904-6831	Metaxalone	Metaxalone	Major Pharmaceuticals	ANDA	Current
0904-6831	Metaxalone	Metaxalone	Major Pharmaceuticals	ANDA	Current
0904-6831	Metaxalone	Metaxalone	Major Pharmaceuticals	ANDA	Current
50090-4448	Metaxalone	Metaxalone	A-S Medication Solutions	ANDA	Current
50090-4448	Metaxalone	Metaxalone	A-S Medication Solutions	ANDA	Current
50228-323	Metaxalone	Metaxalone	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-323	Metaxalone	Metaxalone	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-323	Metaxalone	Metaxalone	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-474	Metaxalone	Metaxalone	ScieGen Pharmaceuticals, Inc.	ANDA	Current
55111-650	Metaxalone	Metaxalone	Dr. Reddy	ANDA	Current
55111-650	Metaxalone	Metaxalone	Dr. Reddy	ANDA	Current
55111-650	Metaxalone	Metaxalone	Dr. Reddy	ANDA	Current
60687-663	Metaxalone	Metaxalone	American Health Packaging	ANDA	Current
67296-1577	Metaxalone	Metaxalone	RedPharm Drug, Inc.	ANDA	Current
67296-1577	Metaxalone	Metaxalone	RedPharm Drug, Inc.	ANDA	Current
67296-1577	Metaxalone	Metaxalone	RedPharm Drug, Inc.	ANDA	Current
68001-485	Metaxalone	Metaxalone	BluePoint Laboratories	ANDA	Current
68001-485	Metaxalone	Metaxalone	BluePoint Laboratories	ANDA	Current
68788-7073	Metaxalone	Metaxalone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7073	Metaxalone	Metaxalone	Preferred Pharmaceuticals Inc.	ANDA	Current
69336-130	Metaxalone	Metaxalone	Sterling-Knight Pharmaceuticals, LLC	ANDA	Current
71205-016	Metaxalone	Metaxalone	Proficient Rx LP	ANDA	Current
71205-016	Metaxalone	Metaxalone	Proficient Rx LP	ANDA	Current
71335-0099	Metaxalone	Metaxalone	Bryant Ranch Prepack	ANDA	Current
71335-0099	Metaxalone	Metaxalone	Bryant Ranch Prepack	ANDA	Current
71335-0099	Metaxalone	Metaxalone	Bryant Ranch Prepack	ANDA	Current
72789-028	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-028	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-028	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-028	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-028	Metaxalone	Metaxalone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current